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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02970942
Registration number
NCT02970942
Ethics application status
Date submitted
18/11/2016
Date registered
22/11/2016
Date last updated
16/11/2021
Titles & IDs
Public title
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
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Scientific title
This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis
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Secondary ID [1]
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2016-000685-39
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Secondary ID [2]
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NN9931-4296
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary Disorders
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Non-alcoholic Steatohepatitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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0
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Metabolic disorders
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Diet and Nutrition
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0
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Obesity
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Cancer
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0
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Liver
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo
Experimental: Semaglutide 0,1 mg -
Experimental: Semaglutide 0,2 mg -
Experimental: Semaglutide 0,4 mg -
Placebo Comparator: Placebo 1 -
Placebo Comparator: Placebo 2 -
Placebo Comparator: Placebo 3 -
Treatment: Drugs: Semaglutide
Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
Treatment: Drugs: Placebo
Once daily administration subcutaneously ( s.c., under the skin)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)
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Assessment method [1]
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NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [1]
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After 72 weeks
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Secondary outcome [1]
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Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)
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Assessment method [1]
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NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.
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Timepoint [1]
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After 72 weeks
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Secondary outcome [2]
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Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)
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Assessment method [2]
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Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [2]
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Baseline (week 0), Week 72
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Secondary outcome [3]
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Percentage of Participants With Change in Steatosis
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Assessment method [3]
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Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [3]
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Baseline (week 0), Week 72
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Secondary outcome [4]
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Percentage of Participants With Change in Lobular Inflammation
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Assessment method [4]
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Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [4]
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Baseline (week 0), Week 72
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Secondary outcome [5]
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Percentage of Participants With Change in Hepatocyte Ballooning
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Assessment method [5]
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Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [5]
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Baseline (week 0), Week 72
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Secondary outcome [6]
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Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification
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Assessment method [6]
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Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [6]
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Baseline (week 0), Week 72
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Secondary outcome [7]
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Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score
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Assessment method [7]
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Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [7]
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Baseline (week 0), Week 72
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Secondary outcome [8]
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Change in Fibrosis-4 Score
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Assessment method [8]
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Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [8]
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Baseline (week 0), Week 72
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Secondary outcome [9]
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Change in NAFLD Fibrosis Score (NFS)
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Assessment method [9]
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Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [9]
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Baseline (week 0), Week 72
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Secondary outcome [10]
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Change in Alanine Aminotransferase (ALT)
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Assessment method [10]
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Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [10]
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Baseline (week 0), Week 72
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Secondary outcome [11]
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Change in Aspartate Aminotransferase (AST)
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Assessment method [11]
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Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [11]
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Baseline (week 0), Week 72
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Secondary outcome [12]
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Change in Gamma Glutamyl Transferase (GGT)
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Assessment method [12]
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Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [12]
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Baseline (week 0), Week 72
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Secondary outcome [13]
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Change in Albumin
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Assessment method [13]
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Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [13]
0
0
Baseline (week 0), Week 72
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Secondary outcome [14]
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Change in International Normalized Ratio (INR)
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Assessment method [14]
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Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [14]
0
0
Baseline (week 0), Week 72
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Secondary outcome [15]
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Change in Enhanced Liver Fibrosis (ELF)
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Assessment method [15]
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Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) = 7.7 - < 9.8: Moderate fibrosis; c) = 9.8 - < 11.3: Severe fibrosis; d) = 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [15]
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Baseline (week 0), Week 72
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Secondary outcome [16]
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Change in Cytokeratin 18 (CK-18) Fragments
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Assessment method [16]
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Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [16]
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Baseline (week 0), Week 72
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Secondary outcome [17]
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Change in microRNA 122 (miR-122)
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Assessment method [17]
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Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [17]
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Baseline (week 0), Week 72
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Secondary outcome [18]
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Change in Interleukin-1 Receptor (IL-1R) Antagonist
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Assessment method [18]
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Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [18]
0
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Baseline (week 0), Week 72
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Secondary outcome [19]
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Change in Monocyte Chemoattractant Protein 1 (MCP-1)
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Assessment method [19]
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Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [19]
0
0
Baseline (week 0), Week 72
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Secondary outcome [20]
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Change in Fibroblast Growth Factor 21 (FGF-21)
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Assessment method [20]
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Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [20]
0
0
Baseline (week 0), Week 72
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Secondary outcome [21]
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Change in Liver Stiffness Assessed by FibroScan®
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Assessment method [21]
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Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [21]
0
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Baseline (week 0), Week 72
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Secondary outcome [22]
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Change in Liver Steatosis Assessed by FibroScan®
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Assessment method [22]
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Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ~3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [22]
0
0
Baseline (week 0), Week 72
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Secondary outcome [23]
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Percentage of Participants With Weight Loss of = 5% of Baseline Body Weight at 72 Weeks (Yes/No)
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Assessment method [23]
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Percentage of participants with weight loss of greater than or equal to (=) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved = 5% weight loss; 'No' infers percentage of participants who have not achieved = 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
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Timepoint [23]
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Week 72
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Secondary outcome [24]
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Percentage of Participants With Weight Loss of = 10% of Baseline Body Weight at 72 Weeks (Yes/No)
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Assessment method [24]
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Pentage of participants with weight loss of = 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved = 10% weight loss; 'No' infers percentage of participants who have not achieved = 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).
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Timepoint [24]
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0
Week 72
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Secondary outcome [25]
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Change in Body Weight
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Assessment method [25]
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Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [25]
0
0
Baseline (week 0), Week 72
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Secondary outcome [26]
0
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Change in Waist Circumference
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Assessment method [26]
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Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [26]
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0
Baseline (week 0), Week 72
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Secondary outcome [27]
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Change in Body Mass Index (BMI)
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Assessment method [27]
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Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [27]
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0
Baseline (week 0), Week 72
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Secondary outcome [28]
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Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
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Assessment method [28]
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Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [28]
0
0
Baseline (week 0), Week 72
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Secondary outcome [29]
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0
Change in HbA1c (Millimoles Per Mole)
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Assessment method [29]
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Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [29]
0
0
Baseline (week 0), Week 72
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Secondary outcome [30]
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0
Change in Fasting Plasma Glucose (FPG)
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Assessment method [30]
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Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [30]
0
0
Baseline (week 0), Week 72
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Secondary outcome [31]
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0
Change in Fasting Glucagon
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Assessment method [31]
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Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [31]
0
0
Baseline (week 0), Week 72
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Secondary outcome [32]
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0
Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)
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Assessment method [32]
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Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [32]
0
0
Baseline (week 0), Week 72
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Secondary outcome [33]
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0
Change in Diastolic Blood Pressure (DBP)
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Assessment method [33]
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0
Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [33]
0
0
Baseline (week 0), Week 72
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Secondary outcome [34]
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Change in Systolic Blood Pressure (SBP)
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Assessment method [34]
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0
Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
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Timepoint [34]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [35]
0
0
Change in Total Cholesterol
Query!
Assessment method [35]
0
0
Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [35]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [36]
0
0
Change in Low Density Lipoprotein (LDL) Cholesterol
Query!
Assessment method [36]
0
0
Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [36]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [37]
0
0
Change in High Density Lipoprotein (HDL) Cholesterol
Query!
Assessment method [37]
0
0
Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [37]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [38]
0
0
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Query!
Assessment method [38]
0
0
Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [38]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [39]
0
0
Change in Triglycerides
Query!
Assessment method [39]
0
0
Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [39]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [40]
0
0
Change in Free Fatty Acids
Query!
Assessment method [40]
0
0
Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [40]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [41]
0
0
Change in High Sensitivity C-reactive Protein (hsCRP)
Query!
Assessment method [41]
0
0
Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [41]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [42]
0
0
Change in Short Form 36 (SF-36) Score
Query!
Assessment method [42]
0
0
Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [42]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [43]
0
0
Number of Treatment-emergent Adverse Events (TEAEs)
Query!
Assessment method [43]
0
0
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [43]
0
0
From week 0 to week 79
Query!
Secondary outcome [44]
0
0
Number of Treatment-emergent Hypoglycaemic Episodes
Query!
Assessment method [44]
0
0
Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [44]
0
0
From week 0 to week 79
Query!
Secondary outcome [45]
0
0
Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes
Query!
Assessment method [45]
0
0
Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.
Query!
Timepoint [45]
0
0
From week 0 to week 79
Query!
Secondary outcome [46]
0
0
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Query!
Assessment method [46]
0
0
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [46]
0
0
From week 0 to week 79
Query!
Secondary outcome [47]
0
0
Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events
Query!
Assessment method [47]
0
0
Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [47]
0
0
From week 0 to week 79
Query!
Secondary outcome [48]
0
0
Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)
Query!
Assessment method [48]
0
0
Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [48]
0
0
From week 0 to week 79
Query!
Secondary outcome [49]
0
0
Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)
Query!
Assessment method [49]
0
0
Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [49]
0
0
From week 0 to week 79
Query!
Secondary outcome [50]
0
0
Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Query!
Assessment method [50]
0
0
Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [50]
0
0
From week 0 to week 79
Query!
Secondary outcome [51]
0
0
Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)
Query!
Assessment method [51]
0
0
Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.
Query!
Timepoint [51]
0
0
From week 0 to week 79
Query!
Secondary outcome [52]
0
0
Change in Pulse From Baseline to Week 72
Query!
Assessment method [52]
0
0
Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [52]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [53]
0
0
Percentage of Participants With Change in Electrocardiogram (ECG)
Query!
Assessment method [53]
0
0
A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [53]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [54]
0
0
Percentage of Participants With Change in Physical Examination: Cardiovascular System
Query!
Assessment method [54]
0
0
Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [54]
0
0
Week -6, week 72
Query!
Secondary outcome [55]
0
0
Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System
Query!
Assessment method [55]
0
0
Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [55]
0
0
Week -6, week 72
Query!
Secondary outcome [56]
0
0
Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth
Query!
Assessment method [56]
0
0
Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [56]
0
0
Week -6, week 72
Query!
Secondary outcome [57]
0
0
Percentage of Participants With Change in Physical Examination: General Appearance
Query!
Assessment method [57]
0
0
Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [57]
0
0
Week -6, week 72
Query!
Secondary outcome [58]
0
0
Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck
Query!
Assessment method [58]
0
0
Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [58]
0
0
Week -6, week 72
Query!
Secondary outcome [59]
0
0
Percentage of Participants With Change in Physical Examination: Lymph Node Palpation
Query!
Assessment method [59]
0
0
Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [59]
0
0
Week -6, week 72
Query!
Secondary outcome [60]
0
0
Percentage of Participants With Change in Physical Examination: Musculoskeletal System
Query!
Assessment method [60]
0
0
Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [60]
0
0
Week -6, week 72
Query!
Secondary outcome [61]
0
0
Percentage of Participants With Change in Physical Examination: Respiratory System
Query!
Assessment method [61]
0
0
Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [61]
0
0
Week -6, week 72
Query!
Secondary outcome [62]
0
0
Percentage of Participants With Change in Physical Examination: Skin
Query!
Assessment method [62]
0
0
Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [62]
0
0
Week -6, week 72
Query!
Secondary outcome [63]
0
0
Percentage of Participants With Change in Physical Examination: Thyroid Gland
Query!
Assessment method [63]
0
0
Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [63]
0
0
Week -6, week 72
Query!
Secondary outcome [64]
0
0
Change in Haematocrit
Query!
Assessment method [64]
0
0
Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [64]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [65]
0
0
Change in Haemoglobin (g/dL)
Query!
Assessment method [65]
0
0
Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [65]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [66]
0
0
Change in Haemoglobin (mmol/L)
Query!
Assessment method [66]
0
0
Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [66]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [67]
0
0
Change in Leukocytes
Query!
Assessment method [67]
0
0
Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [67]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [68]
0
0
Change in Thrombocytes
Query!
Assessment method [68]
0
0
Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [68]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [69]
0
0
Change in Erythrocytes
Query!
Assessment method [69]
0
0
Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [69]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [70]
0
0
Change in Creatinine (mg/dL)
Query!
Assessment method [70]
0
0
Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [70]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [71]
0
0
Change in Creatinine (Umol/L)
Query!
Assessment method [71]
0
0
Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [71]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [72]
0
0
Change in Estimated Glomerular Filtration Rate (eGFR)
Query!
Assessment method [72]
0
0
Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [72]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [73]
0
0
Change in Creatine Kinase
Query!
Assessment method [73]
0
0
Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [73]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [74]
0
0
Change in Urea
Query!
Assessment method [74]
0
0
Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [74]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [75]
0
0
Change in Total Bilirubin (mg/dL)
Query!
Assessment method [75]
0
0
Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [75]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [76]
0
0
Change in Total Bilirubin (Umol/L)
Query!
Assessment method [76]
0
0
Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [76]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [77]
0
0
Change in Alkaline Phosphatase
Query!
Assessment method [77]
0
0
Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [77]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [78]
0
0
Change in Ferritin
Query!
Assessment method [78]
0
0
Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [78]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [79]
0
0
Change in Sodium (mEq/L)
Query!
Assessment method [79]
0
0
Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [79]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [80]
0
0
Change in Sodium (mmol/L)
Query!
Assessment method [80]
0
0
Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [80]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [81]
0
0
Change in Potassium (mEq/L)
Query!
Assessment method [81]
0
0
Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [81]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [82]
0
0
Change in Potassium (mmol/L)
Query!
Assessment method [82]
0
0
Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [82]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [83]
0
0
Change in Calcium (mg/dL)
Query!
Assessment method [83]
0
0
Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [83]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [84]
0
0
Change in Calcium (mmol/L)
Query!
Assessment method [84]
0
0
Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [84]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [85]
0
0
Change in Amylase
Query!
Assessment method [85]
0
0
Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [85]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [86]
0
0
Change in Lipase
Query!
Assessment method [86]
0
0
Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [86]
0
0
Baseline (week 0), Week 72
Query!
Secondary outcome [87]
0
0
Change in Calcitonin
Query!
Assessment method [87]
0
0
Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.
Query!
Timepoint [87]
0
0
Baseline (week 0), Week 72
Query!
Eligibility
Key inclusion criteria
- Informed consent obtained before any trial-related activities.
Trial-related activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial except for protocol described
pre-screening activities which require a separate informed consent. - Male or female, aged
18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive))
at the time of signing informed consent - Local histological diagnosis of NASH followed by
histological confirmation of NASH based on central pathologist evaluation of a liver biopsy
obtained up to 21 weeks before screening - Histologic evidence of NASH based on central
pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH
fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central
pathologist evaluation
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Known or suspected abuse of alcohol (above 20
g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed
by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type
1 diabetes according to medical records - HbA1c above 10% at screening - History or
presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at
screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary
thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) =
25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or
intends to become pregnant or is of childbearing potential and not using an adequate
contraceptive method (adequate contraceptive measures as required by local regulation or
practice)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/11/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/03/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
320
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Kingswood
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - Westmead
Query!
Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Box Hill
Query!
Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
3065 - Fitzroy
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Michigan
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nevada
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Vermont
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Washington
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Graz
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Salzburg
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Wien
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Bruxelles
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Edegem
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Gent
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Sofia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Alberta
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Manitoba
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Nova Scotia
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Quebec
Query!
Country [30]
0
0
Denmark
Query!
State/province [30]
0
0
Aarhus N
Query!
Country [31]
0
0
Denmark
Query!
State/province [31]
0
0
Hvidovre
Query!
Country [32]
0
0
Finland
Query!
State/province [32]
0
0
Helsinki
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Besançon
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Clermont-Ferrand
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Lyon Cedex 4
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
MARSEILLE cedex 08
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Montpellier
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
NICE cedex 3
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Paris
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Pessac
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Toulouse
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Venissieux
Query!
Country [43]
0
0
Greece
Query!
State/province [43]
0
0
Athens
Query!
Country [44]
0
0
Greece
Query!
State/province [44]
0
0
Goudi, Athens
Query!
Country [45]
0
0
Greece
Query!
State/province [45]
0
0
Larissa
Query!
Country [46]
0
0
Greece
Query!
State/province [46]
0
0
Thessaloniki
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Asahikawa-shi, Hokkaido
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Fukui-shi, Fukui
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Kamigyo-ku, Kyoto
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Kumamoto-shi, Kumamoto
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Nagakute-shi, Aichi
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Nara-shi, Nara
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Nishinomiya-shi, Hyogo
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Osaka-shi, Osaka
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Otsu-shi, Shiga
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Saga-shi, Saga
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Shimonoseki-shi, Yamaguchi
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Suita-shi, Osaka
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Takamatsu-shi, Kagawa
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Toyoake-shi, Aichi
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Alkmaar
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Amstelveen
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Amsterdam
Query!
Country [64]
0
0
Netherlands
Query!
State/province [64]
0
0
Delft
Query!
Country [65]
0
0
Netherlands
Query!
State/province [65]
0
0
Groningen
Query!
Country [66]
0
0
Netherlands
Query!
State/province [66]
0
0
Leiden
Query!
Country [67]
0
0
Netherlands
Query!
State/province [67]
0
0
Maastricht
Query!
Country [68]
0
0
Netherlands
Query!
State/province [68]
0
0
Nijmegen
Query!
Country [69]
0
0
Puerto Rico
Query!
State/province [69]
0
0
San Juan
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Barnaul
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Kazan
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Kemerovo
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Krasnoyarsk
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Moscow
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Novosibirsk
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Penza
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Saint-Petersburg
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Saratov
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Stavropol
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Tomsk
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
Ulianovsk
Query!
Country [82]
0
0
Russian Federation
Query!
State/province [82]
0
0
Yoshkar-Ola
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Majadahonda
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Santander
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Santiago de Compostela
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Sevilla
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Valencia
Query!
Country [89]
0
0
Sweden
Query!
State/province [89]
0
0
Göteborg
Query!
Country [90]
0
0
Sweden
Query!
State/province [90]
0
0
Malmö
Query!
Country [91]
0
0
Sweden
Query!
State/province [91]
0
0
Stockholm
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Birmingham
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Bolton
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Cambridge
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Derby
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Country [96]
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State/province [96]
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Dundee
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Country [97]
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United Kingdom
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State/province [97]
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Edinburgh
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Country [98]
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United Kingdom
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State/province [98]
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Glasgow
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Country [99]
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United Kingdom
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State/province [99]
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Hull
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United Kingdom
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Leeds
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London
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Nottingham
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Country [103]
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United Kingdom
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Portsmouth
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Ethics approval
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Summary
Brief summary
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
daily versus placebo in subjects with non-alcoholic steatohepatitis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02970942
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Public notes
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Contacts
Principal investigator
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02970942
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