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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Sponsor: Boehringer Ingelheim
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.
Official title: A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1590
Start Date
2024-11-12
Completion Date
2029-06-05
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Survodutide
Subcutaneous injection, pre-filled syringe
Placebo matching survodutide
Subcutaneous injection, pre-filled syringe
Locations (447)
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
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
Connecticut Gastroenterology Clinical Research Foundation
Bristol, Connecticut, United States
Synergy Healthcare
Bradenton, Florida, United States
Synergy Healthcare of Tampa
Brandon, Florida, United States
Access research Institute
Brooksville, 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
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
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
MplusM - Century Research
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
Advanced Research Institute
New Port Richey, Florida, United States
Charter Research
Orlando, Florida, United States
OMEGA Research Group
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
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
Piedmont Hospital
Atlanta, Georgia, 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 Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 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
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
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
University of Rochester Medical Center
Rochester, New York, United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, United States
Carolina Researche
Greenville, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
ObjectiveHealth-DSI Research - Springboro, LLC
Springboro, Ohio, United States
Northshore Gastroenterology Research
Westlake, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
US Digestive Health
Flourtown, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
US Digestive Health
Lancaster, Pennsylvania, United States
US Digestive Health
Wyomissing, Pennsylvania, United States
ObjectiveHealth-Columbia Digestive Health Research
Columbia, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Innovative Clinical Research
Clarksville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
IMA Clinical Research Austin
Austin, Texas, United States
American Research Corporation - Austin
Austin, Texas, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
Velocity Clinical Research, Austin
Austin, Texas, United States