Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02453711
Registration number
NCT02453711
Ethics application status
Date submitted
21/05/2015
Date registered
25/05/2015
Date last updated
17/04/2020
Titles & IDs
Public title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Query!
Scientific title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Query!
Secondary ID [1]
0
0
2014-001540-38
Query!
Secondary ID [2]
0
0
NN9536-4153
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder
0
0
Query!
Obesity
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - semaglutide
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Experimental: Sema 0.05 mg - Dose 0.05 mg
Experimental: Sema 0.1 mg - Dose 0.05 or 0.1 mg with dose escalation every fourth week
Experimental: Sema 0.2 mg - Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week
Experimental: Sema 0.3 mg - Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week
Experimental: Sema 0.4 mg - Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week
Experimental: Sema 0.3 mg (fast dose escalation) - Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week
Experimental: Sema 0.4 mg (fast dose escalation) - Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week
Active comparator: Lira 3.0 mg - Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week
Placebo comparator: Placebo Sema 0.05 mg - Placebo arm matching active arm Sema 0.05 mg
Placebo comparator: Placebo Sema 0.1 mg - Placebo arm matching active arm Sema 0.1 mg
Placebo comparator: Placebo Sema 0.2 mg - Placebo arm matching active arm Sema 0.2 mg
Placebo comparator: Placebo Sema 0.3 mg - Placebo arm matching active arm Sema 0.3 mg
Placebo comparator: Placebo Sema 0.4 mg - Placebo arm matching active arm Sema 0.4 mg
Placebo comparator: Placebo Sema 0.3 mg (fast dose escalation) - Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)
Placebo comparator: Placebo Sema 0.4 mg (fast dose escalation) - Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)
Placebo comparator: Placebo Lira 3.0 mg - Placebo arm matching active arm Lira 3.0 mg
Treatment: Drugs: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Treatment: Drugs: liraglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Treatment: Drugs: placebo
Once-daily subcutaneous (s.c., under the skin) administration.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Relative Change in Body Weight (%)
Query!
Assessment method [1]
0
0
Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [1]
0
0
Week 0, Week 52
Query!
Secondary outcome [1]
0
0
Participants With Weight Loss of =5% of Baseline Body Weight
Query!
Assessment method [1]
0
0
Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [1]
0
0
Week 52
Query!
Secondary outcome [2]
0
0
Participants With Weight Loss of =10% of Baseline Body Weight
Query!
Assessment method [2]
0
0
Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [2]
0
0
Week 52
Query!
Secondary outcome [3]
0
0
Change in Body Weight (kg)
Query!
Assessment method [3]
0
0
Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [3]
0
0
Week 0, Week 52
Query!
Secondary outcome [4]
0
0
Change in Waist Circumference
Query!
Assessment method [4]
0
0
Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [4]
0
0
Week 0, Week 52
Query!
Secondary outcome [5]
0
0
Change in Waist to Hip Circumference Ratio
Query!
Assessment method [5]
0
0
Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [5]
0
0
Week 0, Week 52
Query!
Secondary outcome [6]
0
0
Change in BMI
Query!
Assessment method [6]
0
0
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [6]
0
0
Week 0, Week 52
Query!
Secondary outcome [7]
0
0
Change in HbA1c
Query!
Assessment method [7]
0
0
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [7]
0
0
Week 0, Week 52
Query!
Secondary outcome [8]
0
0
Change in FPG
Query!
Assessment method [8]
0
0
Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [8]
0
0
Week 0, Week 52
Query!
Secondary outcome [9]
0
0
Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)
Query!
Assessment method [9]
0
0
The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.
Query!
Timepoint [9]
0
0
Week 0, Week 52
Query!
Secondary outcome [10]
0
0
Change in SBP
Query!
Assessment method [10]
0
0
Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [10]
0
0
Week 0, Week 52
Query!
Secondary outcome [11]
0
0
Change in DBP
Query!
Assessment method [11]
0
0
Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [11]
0
0
Week 0, Week 52
Query!
Secondary outcome [12]
0
0
Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
Query!
Assessment method [12]
0
0
Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.
Query!
Timepoint [12]
0
0
Week 0, Week 52
Query!
Secondary outcome [13]
0
0
Change in hsCRP
Query!
Assessment method [13]
0
0
Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [13]
0
0
Week 0, Week 52
Query!
Secondary outcome [14]
0
0
Change in IWQoL Lite
Query!
Assessment method [14]
0
0
The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.
Query!
Timepoint [14]
0
0
Week 0, Week 52
Query!
Secondary outcome [15]
0
0
Change in SF-36
Query!
Assessment method [15]
0
0
Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.
Query!
Timepoint [15]
0
0
Week 0, Week 52
Query!
Secondary outcome [16]
0
0
Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
Query!
Assessment method [16]
0
0
Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [16]
0
0
Week 0, Week 52
Query!
Secondary outcome [17]
0
0
Compliance With Nutritional Counselling
Query!
Assessment method [17]
0
0
This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.
Query!
Timepoint [17]
0
0
Week 4-52
Query!
Secondary outcome [18]
0
0
Number of AEs During the Trial
Query!
Assessment method [18]
0
0
Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [18]
0
0
Week 0-59
Query!
Secondary outcome [19]
0
0
Number of Hypoglycaemic Episodes During the Trial
Query!
Assessment method [19]
0
0
Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values =3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [19]
0
0
Week 0-59
Query!
Secondary outcome [20]
0
0
Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
Query!
Assessment method [20]
0
0
Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [20]
0
0
Week 0-59
Query!
Secondary outcome [21]
0
0
Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
Query!
Assessment method [21]
0
0
This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.
Query!
Timepoint [21]
0
0
Week 52
Query!
Secondary outcome [22]
0
0
Change in ECG
Query!
Assessment method [22]
0
0
Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [22]
0
0
Week 0, week 52
Query!
Secondary outcome [23]
0
0
Change in Pulse
Query!
Assessment method [23]
0
0
Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [23]
0
0
Week 0, week 52
Query!
Secondary outcome [24]
0
0
Change in Haematology: Haemoglobin
Query!
Assessment method [24]
0
0
Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [24]
0
0
Week 0, week 52
Query!
Secondary outcome [25]
0
0
Change in Haematology: Haematocrit
Query!
Assessment method [25]
0
0
Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [25]
0
0
Week 0, week 52
Query!
Secondary outcome [26]
0
0
Change in Haematology: Thrombocytes, Leucocytes and Differential Count
Query!
Assessment method [26]
0
0
Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [26]
0
0
Week 0, week 52
Query!
Secondary outcome [27]
0
0
Change in Haematology: Erythrocytes
Query!
Assessment method [27]
0
0
Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [27]
0
0
Week 0, week 52
Query!
Secondary outcome [28]
0
0
Change in Biochemistry: Creatinine and Bilirubin (Total)
Query!
Assessment method [28]
0
0
Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [28]
0
0
Week 0, week 52
Query!
Secondary outcome [29]
0
0
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Query!
Assessment method [29]
0
0
Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [29]
0
0
Week 0, week 52
Query!
Secondary outcome [30]
0
0
Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
Query!
Assessment method [30]
0
0
Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [30]
0
0
Week 0, week 52
Query!
Secondary outcome [31]
0
0
Change in Biochemistry: Albumin
Query!
Assessment method [31]
0
0
Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [31]
0
0
Week 0, week 52
Query!
Secondary outcome [32]
0
0
Change in Biochemistry: Calcitonin
Query!
Assessment method [32]
0
0
Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [32]
0
0
Week 0, week 52
Query!
Secondary outcome [33]
0
0
Change in Biochemistry: TSH
Query!
Assessment method [33]
0
0
Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [33]
0
0
Week 0, week 52
Query!
Secondary outcome [34]
0
0
Change in Mental Health Assessed by C-SSRS
Query!
Assessment method [34]
0
0
Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [34]
0
0
Week 0 and Week 4-59
Query!
Secondary outcome [35]
0
0
Change in Mental Health Assessed by PHQ-9
Query!
Assessment method [35]
0
0
Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.
Query!
Timepoint [35]
0
0
Week 0, week 52
Query!
Secondary outcome [36]
0
0
Anti-semaglutide Antibodies During and After Treatment
Query!
Assessment method [36]
0
0
Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.
Query!
Timepoint [36]
0
0
Week 0-52
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 - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - 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
1/10/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/04/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
957
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 - Merewether
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - St Leonards
Query!
Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - Heidelberg Heights
Query!
Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2291 - Merewether
Query!
Recruitment postcode(s) [3]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [4]
0
0
3081 - Heidelberg Heights
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
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
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oregon
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Bruxelles
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Edegem
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Leuven
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Liège
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Mons
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Alberta
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
British Columbia
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
New Brunswick
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Nova Scotia
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Ontario
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Quebec
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Dresden
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Duisburg
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Leipzig
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Saint Ingbert-Oberwürzbach
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Stuttgart
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Wangen
Query!
Country [31]
0
0
Israel
Query!
State/province [31]
0
0
Haifa
Query!
Country [32]
0
0
Israel
Query!
State/province [32]
0
0
Jerusalem
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Kfar-Saba
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Petah-Tikva
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Tel Hashomer
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Tel-Aviv
Query!
Country [37]
0
0
Russian Federation
Query!
State/province [37]
0
0
Moscow
Query!
Country [38]
0
0
Russian Federation
Query!
State/province [38]
0
0
Novosibirsk
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Penza
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Saint-Petersburg
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
Tumen
Query!
Country [42]
0
0
Russian Federation
Query!
State/province [42]
0
0
Voronezh
Query!
Country [43]
0
0
Russian Federation
Query!
State/province [43]
0
0
Yaroslavl
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Bristol
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
Cambridge
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Glasgow
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Liverpool
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
London
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Luton
Query!
Country [50]
0
0
United Kingdom
Query!
State/province [50]
0
0
Norwich
Query!
Country [51]
0
0
United Kingdom
Query!
State/province [51]
0
0
Rotherham
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02453711
Query!
Trial related presentations / publications
Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16. O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Global Clinical Registry (GCR, 1452)
Query!
Address
0
0
Novo Nordisk A/S
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT02453711/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT02453711/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, P...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02453711
Download to PDF