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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic 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 MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1800
Start Date
2024-10-14
Completion Date
2031-12-27
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Survodutide
Subcutaneous injection, prefilled syringe
Placebo
Subcutaneous injection, prefilled syringe
Locations (532)
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Fresno Clinical Research Center
Fresno, California, United States
Velocity Clinical Research-Gardena-69773
Gardena, 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
ARK Clinical Research
Long Beach, California, United States
Velocity Clinical Research, Westlake
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
California Liver Research Institute
Pasadena, 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
Medical Associates Research Group, Inc.
San Diego, California, United States
Velocity Clinical Research, Santa Ana
Santa Ana, California, United States
Velocity Clinical Research, Van Nuys
Van Nuys, California, United States
Om Research, LLC
Victorville, California, United States
Future Innovative Treatments
Colorado Springs, Colorado, United States
South Denver Gastroenterology PC
Englewood, Colorado, United States
Connecticut Gastroenterology Clinical Research Foundation
Bristol, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
OMEGA Research Group
Altamonte Springs, Florida, United States
Synergy Healthcare
Bradenton, Florida, United States
Synergy Healthcare of Tampa
Brandon, Florida, United States
Access research Institute
Brooksville, Florida, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
K2 Medical Research - Winter Garden
Clermont, Florida, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States
Cenara Clinical Research
Cutler Bay, Florida, United States
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, United States
University of Florida
Gainesville, Florida, United States
Neoclinical Research
Hialeah, Florida, United States
Evolution Clinical Trials
Hialeah Gardens, Florida, United States
Global Research Associates
Homestead, Florida, United States
Lake Center for Clinical Research
Lady Lake, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Research Associates of South Florida, LLC
Miami, Florida, United States
Optimus U Corporation-Miami-69452
Miami, Florida, United States
Schiff Center Liver Diseases
Miami, Florida, United States
BioMed Research & Medical Center
Miami, Florida, United States
ECIR Miami Holdings LLC dba IMIC
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
GI Pros Research
Naples, Florida, United States
Charter Research
Orlando, Florida, United States
K2 Medical Research
Orlando, Florida, United States
Endoscopic Research, Inc
Orlando, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
MplusM - Best Choice Medical and Research Service
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Metabolic Specialist, LLC - Riverview
Riverview, Florida, United States
Global Clinical Professionals
St. Petersburg, Florida, United States
International Center for Research
Tampa, Florida, United States
Charter Research
The Villages, Florida, United States
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, United States
Conquest Research
Winter Park, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
EmVenio Research Center at Prime Healthcare - Riverdale
Riverdale, Georgia, United States
ASHA Clinical Research - Munster, LLC
Hammond, Indiana, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas Medical Clinic PA
Topeka, Kansas, United States
Delta Research Partners, LLC
Bastrop, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
MNGI Digestive Health, PA
Minneapolis, Minnesota, United States
Gastrointestinal Associates, PA
Flowood, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
ObjectiveHealth-GI Associates Research
Columbia, Missouri, United States
Kansas City Research Institute
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Jubilee Clinical Research, Inc
Las Vegas, Nevada, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
IMA Clinical Research-Warren-69742
Warren Township, New Jersey, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Basil Clinical
Laurelton, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States