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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02913105
Registration number
NCT02913105
Ethics application status
Date submitted
13/09/2016
Date registered
23/09/2016
Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
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Scientific title
A Randomized, Patient and Investigator Blinded, Placebo Controlled, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With Non-alcoholic Steatohepatitis (NASH)
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Secondary ID [1]
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CLMB763X2201
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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:
Non-alcoholic Steatohepatitis NASH
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Condition category
Condition code
Oral and Gastrointestinal
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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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Metabolic disorders
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LMB763
Treatment: Drugs - Placebo
Experimental: LMB763 - Oral dose once daily for 12 weeks (84 days)
Placebo comparator: Placebo - Oral dose once daily for 12 weeks (84 days)
Treatment: Drugs: LMB763
Hard Gelatin Capsules
Treatment: Drugs: Placebo
Hard Gelatin Capsule
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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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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. No statistical analysis was planned for this primary outcome measure.
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Timepoint [1]
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From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))
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Primary outcome [2]
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Change From Baseline in Alanine Aminotransferase (ALT) Levels
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Assessment method [2]
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ALT level assessment is one of the diagnostic parameters in Liver function test (LFT). Baseline was defined as the mean of ALT levels at baseline and pre-dose visits. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [2]
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Baseline to Day 84 (Week 12)
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Secondary outcome [1]
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Observed Maximum Plasma Concentration (Cmax) of LMB763
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Assessment method [1]
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No statistical analysis was planned for this outcome measure.
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Timepoint [1]
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0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
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Secondary outcome [2]
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Time to Reach Maximum Concentration (Tmax) of LMB763
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Assessment method [2]
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No statistical analysis was planned for this outcome measure.
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Timepoint [2]
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0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42
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Secondary outcome [3]
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Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763
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Assessment method [3]
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No statistical analysis was planned for this outcome measure.
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Timepoint [3]
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0 to 96 hours post-dose on Days 1 and 42
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Secondary outcome [4]
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Accumulation Ratio (Racc) of LMB763
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Assessment method [4]
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The drug accumulation ratio (Racc) is the ratio of accumulation of drug going from a single dose to steady state with repeated administration.
No statistical analysis was planned for this outcome measure.
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Timepoint [4]
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Day 42
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Secondary outcome [5]
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Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)
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Assessment method [5]
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Participants were to undergo MRI twice (Baseline and End of Treatment) during the course of the study to quantitate liver fat. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [5]
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Baseline to Day 84 (Week 12)
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Secondary outcome [6]
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Change From Baseline in Weight
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Assessment method [6]
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Baseline was defined as the last available measurement prior to the first dose.
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Timepoint [6]
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Baseline to Days 28, 42, 56, 84 and 112 (EOS)
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Secondary outcome [7]
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Change From Baseline in Body Mass Index (BMI)
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Assessment method [7]
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Baseline was defined as the last available measurement prior to the first dose at specified visit (day).
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Timepoint [7]
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Baseline to Days 28, 42, 56, 84 and 112 (EOS)
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Secondary outcome [8]
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Change From Baseline in Waist to Hip Ratio
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Assessment method [8]
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Baseline was defined as the last available measurement prior to the first dose.
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Timepoint [8]
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Baseline to Days 28, 42, 56, 84 and 112 (EOS)
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Secondary outcome [9]
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Change From to Baseline in Liver Stiffness
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Assessment method [9]
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Fibroscan® was performed where available to assess liver stiffness. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [9]
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Baseline to Day 84 (Week 12)
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Secondary outcome [10]
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Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel
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Assessment method [10]
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The ADVIA CentaurR systems' ELF™ test is an in vitro diagnostic multivariate index assay that provides a single score by combining quantitative measurements of hyaluronic acid (HA), amino-terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) in human serum using the ADVIA Centaur XP, ADVIA Centaur XPT, and ADVIA Centaur CP systems in an algorithm. ELF score for the ADVIA Centaur systems is calculated by, first obtaining results for the ADVIA Centaur HA, PIIINP, and TIMP-1 assays and then using the following equation/algorithm:
ADVIA Centaur XP/XPT:
ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln(CP3NP) + 0.394 ln(CTIMP1)
ADVIA Centaur CP:
ELF score = 2.494 + 0.846 ln(CHA) + 0.735 ln(CP3NP) + 0.391 ln(CTIMP1) Concentrations (C) of each assay are in ng/mL
Interpretation of ELF score is as follows:
\< 7.7 None to mild
* 7.7 to \< 9.8 Moderate
* 9.8 Severe
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Timepoint [10]
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Baseline to Days 42 and 84
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Secondary outcome [11]
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Change From Baseline in Fibrosis Biomarker Test
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Assessment method [11]
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Fibrosis Biomarker test included hyaluronic acid (HA), amino-terminal pro-peptide of procollagen type III (PIIINP), and tissue inhibitor of metalloproteinases (TIMP-1) as markers of liver fibrosis. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [11]
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Baseline to Days 42 and 84
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Secondary outcome [12]
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Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)
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Assessment method [12]
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Lipid measurements were collected under fasted conditions. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [12]
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Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
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Secondary outcome [13]
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Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol
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Assessment method [13]
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Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).
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Timepoint [13]
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Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)
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Secondary outcome [14]
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Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin
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Assessment method [14]
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A 10 cm VAS was used to assess the severity of participants itch (ranging from 0 = no itch at all to 10 = the worst imaginable itch). The score (distance from left) on the VAS was recorded by the participant marking with a line and used to test for an effect of LMB763 over placebo. Baseline was defined as the last available measurement prior to the first dose. A positive change from Baseline indicates improvement.
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Timepoint [14]
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Baseline to Day 84 (Week 12)
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Eligibility
Key inclusion criteria
* Male/female patients, 18 years or older
* Written informed consent
* Presence of NASH by histologic evidence (liver biopsy) and elevated alanine aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Current use of obeticholic acid (OCA)
* New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide, albiglutide or dulaglutide within 3 months of screening
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication
* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
* Clinical evidence of hepatic decompensation or severe liver impairment
* Previous diagnosis of other forms of chronic liver disease
* Uncontrolled diabetes mellitus
* History or current diagnosis of ECG abnormalities
* Patients with contraindications to MRI imaging
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/09/2018
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Sample size
Target
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Accrual to date
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Final
122
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Novartis Investigative Site - New Lambton
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Recruitment hospital [2]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Hawaii
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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United States of America
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State/province [9]
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Virginia
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Country [10]
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Georgia
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State/province [10]
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Tbilisi
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Country [11]
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Jordan
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State/province [11]
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Amman
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Country [12]
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New Zealand
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State/province [12]
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Auckland
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Country [13]
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New Zealand
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State/province [13]
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Christchurch
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Country [14]
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New Zealand
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State/province [14]
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Tauranga
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Country [15]
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New Zealand
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State/province [15]
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Wellington
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Country [16]
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Puerto Rico
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State/province [16]
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San Juan
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Country [17]
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Switzerland
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State/province [17]
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Bern
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Country [18]
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Switzerland
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State/province [18]
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Geneve 14
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Country [19]
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Switzerland
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State/province [19]
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Lugano
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Country [20]
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United Kingdom
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State/province [20]
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Devon
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Country [21]
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United Kingdom
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State/province [21]
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Glasgow
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Country [22]
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United Kingdom
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State/province [22]
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
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Trial website
https://clinicaltrials.gov/study/NCT02913105
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/05/NCT02913105/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/05/NCT02913105/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02913105