This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the 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. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,590
Subcutaneous injection
Subcutaneous injection
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, United States
RECRUITINGScottsdale Clinical Trials
Scottsdale, Arizona, United States
RECRUITINGArizona Liver Health - Tucson
Tucson, Arizona, United States
RECRUITINGDel Sol Research Management, LLC
Tucson, Arizona, United States
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
Time frame: up to 4.5 years.
Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time frame: At baseline and at Week 76.
Key secondary endpoint: Percentage change from baseline in body weight
Time frame: At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline
Time frame: At baseline and at Week 76.
Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)
Time frame: At baseline and at Week 76.
Percentage change from baseline in liver stiffness in FibroScan® VCTE
Time frame: At baseline and at Week 76.
Time to first occurrence of progression to CSPH
Time frame: up to 4.5 years.
Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15
Time frame: up to 4.5 years.
Occurrence of all-cause hospitalisation (first and recurrent)
Time frame: up to 4.5 years.
Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)
Time frame: up to 4.5 years.
Absolute changes from baseline in lipids (mg/dL)
Time frame: At baseline and at Week 76.
Absolute change from baseline in aspartate aminotransferase (AST) (U/L)
Time frame: At baseline and at Week 76.
Absolute change from baseline in alanine aminotransferase (ALT) (U/L)
Time frame: At baseline and at Week 76.
Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
Time frame: At baseline and at Week 76.
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Hope Clinical Research
Canoga Park, California, United States
RECRUITINGVelocity Clinical Research-Chula Vista
Chula Vista, California, United States
RECRUITINGSouthern California Research Center
Coronado, California, United States
RECRUITINGARK Clinical Research
Fountain Valley, California, United States
RECRUITINGVelocity Clinical Research-Huntington Park
Huntington Park, California, United States
NOT_YET_RECRUITING310 Clinical Research
Inglewood, California, United States
RECRUITING...and 414 more locations