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Taking people in United StatesPhase 3

Tests survodutide in adults with liver scarring from fatty liver disease

Tests survodutide, a weekly injection, in adults with MASH cirrhosis.

Plain-language title generated from the registry record
Registry title: LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Key facts

Where
Arlington, Atlanta, Austin, Bastrop, Bellaire, Bradenton, Brandon, Bristol, Brooklyn, Brooksville, Brownsville, Canoga Park, Chattanooga, Chula Vista, Clarksville, Clinton Township, Colorado Springs, Columbia, Columbus, Coral Gables, Coronado, Cutler Bay, Dallas, Denison, Englewood, Fayetteville, Flourtown, Fort Myers, Fountain Valley, Garden City, Garland, Georgetown, Greenville, Hammond, Hershey, Hialeah, Hialeah Gardens, Homestead, Houston, Huntington Park, Inglewood, Kansas City, La Mesa, Lady Lake, Lancaster, Las Vegas, Laurelton, Lewisville, Macon, Mansfield, Marrero, McAllen, Mentor, Miami, Miami Lakes, Minneapolis, Montclair, Nashville, New Port Richey, New York, Omaha, Orange, Orlando, Oxnard, Palmetto Bay, Pembroke Pines, Peoria, Poway, Raleigh, Rialto, Richmond, Riverdale, Riverview, Rochester, San Antonio, San Bernardino, San Diego, Scottsdale, Seattle, Shreveport, South Bend, Spokane, Springboro, St. Petersburg, Summerville, Tampa, The Villages, Tucson, Tulsa, University Park, Waco, Warren Township, West Des Moines, Westlake, Wichita Falls, Winter Park, Wyoming, Wyomissing, and Zephyrhills, United StatesSee the 126 sites
Phase
Phase 3

Where in United States

  • Texas Clinical Research Institute, LLCArlington, United StatesTaking people
  • Piedmont HospitalAtlanta, United StatesTaking people
  • American Research Corporation - AustinAustin, United StatesTaking people
  • IMA Clinical Research AustinAustin, United StatesTaking people
  • Pinnacle Clinical Research - AustinAustin, United StatesTaking people
  • Velocity Clinical Research AustinAustin, United StatesTaking people
  • Delta Research Partners, LLCBastrop, United StatesTaking people
  • Pinnacle Clinical Research, LLCBellaire, United StatesTaking people
  • Synergy HealthcareBradenton, United StatesTaking people
  • Synergy Healthcare of TampaBrandon, United StatesTaking people
  • Connecticut Gastroenterology Clinical Research FoundationBristol, United StatesTaking people
  • NewYork-Presbyterian Brooklyn Methodist HospitalBrooklyn, United StatesTaking people
  • Access Research InstituteBrooksville, United StatesTaking people
  • South Texas Research Institute - BrownsvilleBrownsville, United StatesTaking people
  • Hope Clinical ResearchCanoga Park, United StatesTaking people
  • ClinSearch LLCChattanooga, United StatesTaking people
  • Velocity Clinical Research, Chula VistaChula Vista, United StatesTaking people
  • Innovative Clinical ResearchClarksville, United StatesTaking people
  • Clinical Research Institute of Michigan, LLCClinton Township, United StatesTaking people
  • Future Innovative TreatmentsColorado Springs, United StatesTaking people
  • ObjectiveHealth-Columbia Digestive Health ResearchColumbia, United StatesTaking people
  • ObjectiveHealth-GI Associates ResearchColumbia, United StatesTaking people
  • The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
  • Hi Tech and Global Research, LLCCoral Gables, United StatesTaking people
  • Southern California Research CenterCoronado, United StatesTaking people
  • Cenara Clinical ResearchCutler Bay, United StatesTaking people
  • Dallas Research InstituteDallas, United StatesTaking people
  • GI Alliance Research - DallasDallas, United StatesTaking people
  • Zenos Clinical ResearchDallas, United StatesTaking people
  • Soma Clinical TrialsDenison, United StatesTaking people
  • South Denver Gastroenterology PCEnglewood, United StatesTaking people
  • Coastal Research Institute, LLCFayetteville, United StatesTaking people
  • US Digestive HealthFlourtown, United StatesTaking people
  • Covenant Metabolic Specialists, LLC - Fort MyersFort Myers, United StatesTaking people
  • Ark Clinical ResearchFountain Valley, United StatesTaking people
  • EmVenio Research Center at Prime Healthcare - Farmers BranchGarden City, United StatesTaking people
  • DHAT Reseach InstituteGarland, United StatesTaking people
  • Pinnacle Clinical Research, LLCGeorgetown, United StatesTaking people
  • Carolina ResearcheGreenville, United StatesTaking people
  • ASHA Clinical Research-Munster, LLCHammond, United StatesTaking people
  • Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
  • NeoClinical ResearchHialeah, United StatesTaking people
  • Evolution Clinical TrialsHialeah Gardens, United StatesTaking people
  • Global Research AssociatesHomestead, United StatesTaking people
  • Ben Taub General HospitalHouston, United StatesTaking people
  • Biopharma Informatic, Inc. Research CenterHouston, United StatesTaking people
  • Research Physicians NetworkHouston, United StatesTaking people
  • Velocity Clinical Research-Huntington ParkHuntington Park, United StatesTaking people
  • 310 Clinical ResearchInglewood, United StatesTaking people
  • Kansas City Research InstituteKansas City, United StatesTaking people
  • Velocity Clinical Research, San DiegoLa Mesa, United StatesTaking people
  • Lake Center for Clinical ResearchLady Lake, United StatesTaking people
  • Om Research LLCLancaster, United StatesTaking people
  • US Digestive HealthLancaster, United StatesTaking people
  • Clinical Research of South NevadaLas Vegas, United StatesTaking people
  • Excel Clinical ResearchLas Vegas, United StatesTaking people
  • Jubilee Clinical Research, Inc.Las Vegas, United StatesTaking people
  • Basil ClinicalLaurelton, United StatesTaking people
  • Epic Clinical ResearchLewisville, United StatesTaking people
  • Gastroenterology Associates of Central GeorgiaMacon, United StatesTaking people
  • GI Alliance Research - MansfieldMansfield, United StatesTaking people
  • Tandem Clinical ResearchMarrero, United StatesTaking people
  • Biopharma Informatic, LLCMcAllen, United StatesTaking people
  • Centex Studies, Inc.McAllen, United StatesTaking people
  • Great Lakes GastroenterologyMentor, United StatesTaking people
  • BioMed Research & Medical CenterMiami, United StatesTaking people
  • ECIR Miami Holdings LLC dba IMICMiami, United StatesTaking people
  • Entrust Clinical ResearchMiami, United StatesTaking people
  • MplusM - Century ResearchMiami, United StatesTaking people
  • Optimus U Corporation-Miami-69452Miami, United StatesTaking people
  • Research Associates of South Florida, LLCMiami, United StatesTaking people
  • Schiff Center Liver DiseasesMiami, United StatesTaking people
  • Floridian Clinical ResearchMiami Lakes, United StatesTaking people
  • MNGI Digestive Health, PAMinneapolis, United StatesTaking people
  • Catalina Research Institute, LLCMontclair, United StatesTaking people
  • Vanderbilt University Medical CenterNashville, United StatesTaking people
  • Advanced Research InstituteNew Port Richey, United StatesTaking people
  • Icahn School of Medicine at Mount SinaiNew York, United StatesNot yet recruiting
  • University of Nebraska Medical CenterOmaha, United StatesTaking people
  • Clinnova Research SolutionsOrange, United StatesTaking people
  • Charter ResearchOrlando, United StatesTaking people
  • Endoscopic Research, IncOrlando, United StatesTaking people
  • OMEGA Research GroupOrlando, United StatesTaking people
  • Fomat Medical ResearchOxnard, United StatesTaking people
  • Innovation Medical Research CenterPalmetto Bay, United StatesTaking people
  • MplusM - Best Choice Medical and Research ServicePembroke Pines, United StatesTaking people
  • The Institute for Liver Health II DBA Arizona Clinical TrialsPeoria, United StatesTaking people
  • Cadena Care Institute, LLCPoway, United StatesTaking people
  • Ficramed Research InstitutePoway, United StatesTaking people
  • M3 Wake Research, Inc.Raleigh, United StatesTaking people
  • Inland Empire Clinical Trials, LLCRialto, United StatesTaking people
  • GI Select Health Research, LLCRichmond, United StatesTaking people
  • VCU Medical Center West HospitalRichmond, United StatesNot yet recruiting
  • EmVenio Research Center at Prime Healthcare - RiverdaleRiverdale, United StatesTaking people
  • Covenant Metabolic Specialist, LLC - RiverviewRiverview, United StatesTaking people
  • University of Rochester Medical CenterRochester, United StatesTaking people
  • American Research Corporation at the Texas Liver InstituteSan Antonio, United StatesTaking people
  • Brooke Army Medical CenterSan Antonio, United StatesTaking people
  • HASresearchSan Antonio, United StatesTaking people
  • Metro Clinical TrialsSan Bernardino, United StatesTaking people
  • Acclaim Clinical ResearchSan Diego, United StatesTaking people
  • Scottsdale Medical Specialists, LtdScottsdale, United StatesTaking people
  • Velocity Clinical Research, SeattleSeattle, United StatesTaking people
  • Louisiana Research Center, LLCShreveport, United StatesTaking people
  • Digestive Research Alliance of MichianaSouth Bend, United StatesTaking people
  • Velocity Clinical Research-Spokane-69716Spokane, United StatesTaking people
  • ObjectiveHealth-DSI Research - Springboro, LLCSpringboro, United StatesTaking people
  • Global Clinical ProfessionalsSt. Petersburg, United StatesTaking people
  • Palmetto Clinical ResearchSummerville, United StatesTaking people
  • International Center for ResearchTampa, United StatesTaking people
  • Charter ResearchThe Villages, United StatesTaking people
  • Adobe Clinical Research LLCTucson, United StatesTaking people
  • Arizona Liver Health - TucsonTucson, United StatesTaking people
  • Del Sol Research Management, LLCTucson, United StatesTaking people
  • Options Health ResearchTulsa, United StatesTaking people
  • Covenant Metabolic Specialists, LLC - University ParkUniversity Park, United StatesTaking people
  • Objective Health-Digestive Research of Central TexasWaco, United StatesTaking people
  • Velocity Clinical Research, WacoWaco, United StatesTaking people
  • IMA Clinical Research-Warren-69742Warren Township, United StatesTaking people
  • Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United StatesTaking people
  • Northshore Gastroenterology ResearchWestlake, United StatesTaking people
  • ObjectiveHealth-Digestive Health Research of North TexasWichita Falls, United StatesTaking people
  • Conquest ResearchWinter Park, United StatesTaking people
  • West Michigan Clinical Research CenterWyoming, United StatesTaking people
  • US Digestive HealthWyomissing, United StatesTaking people
  • Florida Medical Clinic, P.A.Zephyrhills, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Boehringer Ingelheim
Trial code
NCT06632457EU 2024-513741-36-00
Record updated
28 October 2026
Original description
This study is open to adults who are at least 18 years old and have:Read full original descriptionShow less

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

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.

Inclusion: 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; Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants); Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis; 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; Further inclusion criteria apply.

Exclusion: Model of end-stage liver Disease (MELD) score >12 due to liver disease; 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; 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; Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection; Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA)); Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history; History of liver transplantation or listed for liver transplantation; History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment; 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); Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN; 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; Further exclusion criteria apply.

ClinicalTrials.gov NCT06632457 · EU CTIS 2024-513741-36-00