A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight
- Conditions
- ObesityNon-Alcoholic SteatoHepatitis (NASH)
- Interventions
- Drug: Placebo
- Registration Number
- NCT06309992
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults who are at least 18 years old and have
* presumed or confirmed NASH together with overweight or obesity and
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² and at least one weight-related health problem.
People with a history of other chronic liver diseases cannot take part in this study.
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 218
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Placebo - Treatment arm Survodutide -
- Primary Outcome Measures
Name Time Method Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [%] at baseline, at week 48 Relative change (%) in body weight [kg] from baseline to Week 48 at baseline, at week 48
- Secondary Outcome Measures
Name Time Method Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%] at baseline, at week 48 Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%] at baseline, at week 48 Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels at baseline, at week 48 Relative change from baseline to Week 48 in waist circumference [cm] at baseline, at week 48 Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5) at baseline, at week 48 Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE) at baseline, at week 48 Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI at baseline, at week 48 Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels at baseline, at week 48 Relative change in liver volume [mL] from baseline to Week 48 measured using MRI at baseline, at week 48 Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no) at baseline, at week 48 Absolute change from baseline to Week 48 in waist circumference [cm] at baseline, at week 48 Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE) at baseline, at week 48
Trial Locations
- Locations (38)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Gastroenterology and Liver Research LLC
🇺🇸Houston, Texas, United States
Accurate Clinical Research, Inc.
🇺🇸Humble, Texas, United States
Amsterdam UMC, location VUMC
🇳🇱Amsterdam, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
🇳🇱Rotterdam, Netherlands
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
ARK Clinical Research
🇺🇸Long Beach, California, United States
Velocity Clinical Research-Gardena-69773
🇺🇸Gardena, California, United States
Catalina Research Institute, LLC-Montclair-69754
🇺🇸Montclair, California, United States
Scroll for more (28 remaining)Medical University of South Carolina🇺🇸Charleston, South Carolina, United States