🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06632457
Recruiting Phase 3

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

NCT06632457 · tracked via the Priya Life Science India tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2024-11-12
Last updated
2026-09-03

Condition(s) studied

Metabolic Dysfunction Associated Steatohepatitis

Investigational drug(s) / intervention(s)

SurvodutidePlacebo matching survodutide

Survodutide: Subcutaneous injection, pre-filled syringe

Placebo matching survodutide: Subcutaneous injection, pre-filled syringe

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (445)

FacilityCityRegionStatus
The Institute for Liver Health II DBA Arizona Clinical Trials Peoria Arizona Recruiting
Scottsdale Medical Specialists, Ltd Scottsdale Arizona Recruiting
Adobe Clinical Research, LLC Tucson Arizona Recruiting
Arizona Liver Health - Tucson Tucson Arizona Recruiting
Del Sol Research Management, LLC Tucson Arizona Recruiting
Hope Clinical Research Canoga Park California Recruiting
Velocity Clinical Research-Chula Vista Chula Vista California Recruiting
Southern California Research Center Coronado California Recruiting
ARK Clinical Research Fountain Valley California Recruiting
Velocity Clinical Research-Huntington Park Huntington Park California Recruiting
310 Clinical Research Inglewood California Recruiting
Velocity Clinical Research, San Diego La Mesa California Recruiting
Om Research, LLC Lancaster California Recruiting
Catalina Research Institute, LLC Montclair California Recruiting
Clinnova Research Solutions Orange California Recruiting
Fomat Medical Research Oxnard California Recruiting
Cadena Care Institute, LLC Poway California Recruiting
Ficramed Research Institute Poway California Recruiting
Inland Empire Clinical Trials, LLC Rialto California Recruiting
Metro Clinical Trials San Bernardino California Recruiting
Acclaim Clinical Research San Diego California Recruiting
Future Innovative Treatments Colorado Springs Colorado Recruiting
South Denver Gastroenterology PC Englewood Colorado Recruiting
Connecticut Gastroenterology Clinical Research Foundation Bristol Connecticut Recruiting
Synergy Healthcare Bradenton Florida Recruiting
Synergy Healthcare of Tampa Brandon Florida Recruiting
Access research Institute Brooksville Florida Recruiting
Hi Tech and Global Research, LLC Coral Gables Florida Recruiting
Cenara Clinical Research Cutler Bay Florida Recruiting
Covenant Metabolic Specialists, LLC - Fort Myers Fort Myers Florida Recruiting
Neoclinical Research Hialeah Florida Recruiting
Evolution Clinical Trials Hialeah Gardens Florida Recruiting
Global Research Associates Homestead Florida Recruiting
Lake Center for Clinical Research Lady Lake Florida Recruiting
Research Associates of South Florida, LLC Miami Florida Recruiting
Optimus U Corporation-Miami-69452 Miami Florida Recruiting
Schiff Center Liver Diseases Miami Florida Recruiting
BioMed Research & Medical Center Miami Florida Recruiting
MplusM - Century Research Miami Florida Recruiting
ECIR Miami Holdings LLC dba IMIC Miami Florida Recruiting

+ 405 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06632457 on ClinicalTrials.gov ↗ ← All trials in India