Taking people in United StatesPhase 3

Tests survodutide in adults with liver disease and moderate or advanced liver fibrosis

Tests survodutide weekly injections against placebo in adults with fatty liver disease and scarring.

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

Key facts

Where: Altamonte Springs, Arlington, Austin, Baltimore, Bastrop, Bellaire, Birmingham, Boston, Bradenton, Brandon, Bristol, Brooklyn, Brooksville, Brownsville, Canoga Park, Carrollton, Charleston, Chattanooga, Chesterfield, Chula Vista, Clarksville, Clearwater, Clermont, Clinton Township, Clive, Colorado Springs, Columbia, Columbus, Coral Gables, Coronado, Corpus Christi, Cutler Bay, Dallas, Denison, DeSoto, Durham, Edinburg, Englewood, Fayetteville, Flourtown, Flowood, Forney, Fort Myers, Fountain Valley, Fresno, Gainesville, Garden City, Gardena, Garland, Georgetown, Greenville, Hammond, Hershey, Hialeah, Hialeah Gardens, Homestead, Houston, Huntington Park, Inglewood, Kansas City, La Mesa, Lady Lake, Lakewood Rch, Lancaster, Las Vegas, Laurelton, Lewisville, Long Beach, Los Angeles, Macon, Maitland, Mansfield, Marrero, McAllen, Mentor, Miami, Miami Lakes, Minneapolis, Montclair, Naples, Nashville, New Bern, New Haven, New York, Newport News, Omaha, Orange, Orlando, Oxnard, Palmetto Bay, Pasadena, Pembroke Pines, Peoria, Plano, Port Orange, Poway, Raleigh, Rialto, Richmond, Riverdale, Riverview, Rochester, San Antonio, San Bernardino, San Diego, Santa Ana, Scottsdale, Seattle, Shreveport, South Bend, Spokane, Springboro, St. Petersburg, State College, Summerville, Tampa, The Villages, Topeka, Tucson, Tulsa, University Park, Van Nuys, Victorville, Waco, Warren Township, West Des Moines, Westlake, Wichita Falls, Winter Park, Wyoming, Wyomissing, and Zephyrhills, United StatesSee the 165 sites
Phase: Phase 3

Where in United States

OMEGA Research GroupAltamonte Springs, United StatesTaking people
Texas Clinical Research Institute, LLCArlington, 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
Mercy Medical CenterBaltimore, United StatesTaking people
Delta Research Partners, LLCBastrop, United StatesTaking people
Bellaire Clinical Research, LLCBellaire, United StatesTaking people
University of Alabama at BirminghamBirmingham, United StatesNot yet recruiting
Boston Medical CenterBoston, 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
Epic Medical Research - CarrolltonCarrollton, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
ClinSearch LLCChattanooga, United StatesTaking people
Clinical Research ProfessionalsChesterfield, United StatesTaking people
Velocity Clinical Research, Chula VistaChula Vista, United StatesTaking people
Innovative Clinical ResearchClarksville, United StatesTaking people
Tampa Bay Medical ResearchClearwater, United StatesTaking people
K2 Medical Research WINTER GARDENClermont, United StatesTaking people
Clinical Research Institute of Michigan, LLCClinton Township, United StatesTaking people
Iowa Digestive Disease CenterClive, 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
Pinnacle Clinical Research - Corpus ChristiCorpus Christi, United StatesTaking people
Cenara Clinical ResearchCutler Bay, United StatesTaking people
Dallas Research InstituteDallas, United StatesTaking people
GI Alliance Research - DallasDallas, United StatesTaking people
Velocity Clinical Research-Dallas-69170Dallas, United StatesTaking people
Zenos Clinical ResearchDallas, United StatesTaking people
Soma Clinical TrialsDenison, United StatesTaking people
Epic Medical Research - DeSotoDeSoto, United StatesTaking people
Duke University Medical CenterDurham, United StatesNot yet recruiting
South Texas Research Institute-Edinburg-67012Edinburg, United StatesTaking people
South Denver Gastroenterology PCEnglewood, United StatesTaking people
Coastal Research Institute, LLCFayetteville, United StatesTaking people
US Digestive HealthFlourtown, United StatesTaking people
Gastrointestinal Associates, PAFlowood, United StatesTaking people
Care United ResearchForney, United StatesTaking people
Covenant Metabolic Specialists, LLC - Fort MyersFort Myers, United StatesTaking people
Ark Clinical ResearchFountain Valley, United StatesTaking people
Fresno Clinical Research CenterFresno, United StatesTaking people
University of FloridaGainesville, United StatesNot yet recruiting
EmVenio Research Center at Prime Healthcare - Farmers BranchGarden City, United StatesTaking people
Velocity Clinical Research-Gardena-69773Gardena, United StatesTaking people
Epic Medical Research - GarlandGarland, 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
HRI- Medical 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
University of Kansas Medical CenterKansas City, United StatesNot yet recruiting
Velocity Clinical Research, San DiegoLa Mesa, United StatesTaking people
Lake Center for Clinical ResearchLady Lake, United StatesTaking people
Florida Research InstituteLakewood Rch, 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
Ark Clinical ResearchLong Beach, United StatesTaking people
Velocity Clinical Research, WestlakeLos Angeles, United StatesTaking people
Gastroenterology Associates of Central GeorgiaMacon, United StatesTaking people
K2 Medical ResearchMaitland, 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
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
GI PROS ResearchNaples, United StatesTaking people
Vanderbilt University Medical CenterNashville, United StatesTaking people
Centricity Research (New Bern)New Bern, United StatesTaking people
Yale University School Of MedicineNew Haven, United StatesTaking people
Icahn School of Medicine at Mount SinaiNew York, United StatesNot yet recruiting
Liver Institute of Virginia-BremoNewport News, 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
K2 Medical ResearchOrlando, United StatesNo longer taking part
Fomat Medical ResearchOxnard, United StatesTaking people
Innovation Medical Research CenterPalmetto Bay, United StatesTaking people
California Liver Research InstitutePasadena, 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
Epic Medical Research - PlanoPlano, United StatesTaking people
Progressive Medical ResearchPort Orange, 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 StatesTaking people
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
Clinical Trials of Texas LLCSan Antonio, United StatesTaking people
HASresearchSan Antonio, United StatesTaking people
Pinnacle Clinical Research - San AntonioSan Antonio, United StatesTaking people
Pinnacle Clinical Research, LLCSan Antonio, United StatesTaking people
Metro Clinical TrialsSan Bernardino, United StatesTaking people
Acclaim Clinical ResearchSan Diego, United StatesTaking people
Medical Associates Research Group, Inc.San Diego, United StatesNot yet recruiting
Velocity Clinical Research, Santa AnaSanta Ana, United StatesNo longer taking part
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
Geisinger HealthState College, United StatesNot yet recruiting
Palmetto Clinical ResearchSummerville, United StatesTaking people
International Center for ResearchTampa, United StatesTaking people
Charter ResearchThe Villages, United StatesTaking people
Kansas Medical Clinic PATopeka, 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
Velocity Clinical Research, Van NuysVan Nuys, United StatesTaking people
Om Research, LLCVictorville, 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

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

Print a page for my doctor

Trial details

Who runs it: Boehringer Ingelheim
Trial code: NCT06632444 EU 2024-513739-25-00
Record updated: 28 October 2026
Original description: This study is open to adults who are at least 18 years old living with obesity and have:Read full original descriptionShow less
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
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.
Inclusion: Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent; Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score [NAS] ≥4; Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used; Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply.
Exclusion: Any history or evidence of acute or chronic liver disease other than MASH; History of or current diagnosis of hepatocellular carcinoma; History of or planned liver transplant; History of portal hypertension or presence of decompensated liver disease; Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply; Any of the following liver laboratory test abnormalities at screening:; Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN); Platelet count <140 000/mm\^3 (<140 GI/L); Alkaline phosphatase >2x upper limit of normal (ULN); Abnormal synthetic liver function as defined by screening central laboratory evaluation:; Albumin below <3.5 g/dL (35.0 g/L); OR International normalised ratio (INR) of prothrombin time >1.3; OR total serum bilirubin concentration ≥1.5x ULN; Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy; Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
ClinicalTrials.gov NCT06632444 · EU CTIS 2024-513739-25-00