COMBINATION_PRODUCT
Survodutide
Subcutaneous injection, pre-filled syringe
Status
Recruiting
Phase
Phase 3
Enrollment
1,590
Locations
444
Results
Not posted
Publications
0
Study summary
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.
Interventions
COMBINATION_PRODUCT
Subcutaneous injection, pre-filled syringe
COMBINATION_PRODUCT
Subcutaneous injection, pre-filled syringe
Timeline
First posted
Oct 9, 2024
Study start
Nov 7, 2024
Primary completion
Jun 5, 2029
Study completion
Jun 5, 2029
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
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
Time frame · up to 4.5 years.
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
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.
Eligibility
Inclusion criteria: 1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants) 3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. 4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis. 5. Further inclusion criteria apply. Exclusion criteria: 1. Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator. 2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease 3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to: * Portal hypertension-related upper gastrointestinal (GI) bleeding * Ascites * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria 4. Any of the following lab test result at screening * Albumin below \<3.5 g/dL (\<35.0 g/L) * International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants * Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL. * Alkaline phosphatase \>1.5x ULN * PLT \<100,000/µL (\<100 GI/L) 5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis 6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection 7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA)) 8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN 9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history 10. History of liver transplantation or listed for liver transplantation 11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment 12. Further exclusion criteria apply
Study locations
Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · Chile · China · Czechia · France · Georgia · Germany · Hungary · India · Italy · Japan · Jordan · Kazakhstan · Malaysia · Mexico · Netherlands · New Zealand · Poland · Puerto Rico · Romania · Saudi Arabia · Singapore · South Africa · South Korea · Spain · Switzerland · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, Arizona, United States
Scottsdale Medical Specialists, Ltd
Scottsdale, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
Velocity Clinical Research-Chula Vista
Chula Vista, California, United States
Southern California Research Center
Coronado, California, United States
ARK Clinical Research
Fountain Valley, California, United States
Velocity Clinical Research-Huntington Park
Huntington Park, California, United States
310 Clinical Research
Inglewood, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
Om Research, LLC
Lancaster, California, United States
Delta Research Partners, LLC
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Clinnova Research Solutions
Orange, California, United States
Fomat Medical Research
Oxnard, California, United States
Cadena Care Institute, LLC
Poway, California, United States
Ficramed Research Institute
Poway, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Metro Clinical Trials
San Bernardino, California, United States
Acclaim Clinical Research
San Diego, California, United States
Future Innovative Treatments
Colorado Springs, Colorado, United States
South Denver Gastroenterology PC
Englewood, Colorado, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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