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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
248
Survodutide
Placebo matching survodutide
ARK Clinical Research
Fountain Valley, California, United States
Velocity Clinical Research-Gardena-69773
Gardena, California, United States
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Long Beach, California, United States
Catalina Research Institute, LLC - Montclair
Montclair, California, United States
Velocity Clinical Research-North Hollywood-69852
North Hollywood, California, United States
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) [%]
Time frame: at baseline, at week 48
Relative change (%) in body weight [kg] from baseline to Week 48
Time frame: at baseline, at week 48
Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]
Time frame: at baseline, at week 48
Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%]
Time frame: at baseline, at week 48
Reduction from baseline to Week 48 in Iron corrected T1 (cT1) [ms] levels of ≥80 ms (yes/no)
Time frame: at baseline, at week 48
Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels
Time frame: at baseline, at week 48
Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels
Time frame: at baseline, at week 48
Absolute change from baseline to Week 48 in waist circumference [cm]
Time frame: at baseline, at week 48
Relative change from baseline to Week 48 in waist circumference [cm]
Time frame: 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)
Time frame: at baseline, at week 48
Relative change from baseline to Week 48 in HOMA-IR (FPI [mlU/L] · FPG [mmol/L]/22.5)
Time frame: at baseline, at week 48
Absolute change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)
Time frame: at baseline, at week 48
Relative change from baseline to Week 48 in liver stiffness [kPa] assessed by magnetic resonance elastography (MRE)
Time frame: at baseline, at week 48
Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI
Time frame: at baseline, at week 48
Relative change in liver volume [mL] from baseline to Week 48 measured using MRI
Time frame: at baseline, at week 48
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