Recruiting
Phase 3

Survodutide

Sponsor:

Boehringer Ingelheim

Code:

NCT06632457

Conditions

Metabolic Dysfunction Associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survodutide

Placebo matching survodutide

Study Details

Brief 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.

Conditions

Metabolic Dysfunction Associated Steatohepatitis

Study ID

NCT06632457

Start date

Nov 12, 2024

Status verified date

Aug, 2026

Completion date

Jun 5, 2029

Anticipated

Primary completion date

Jun 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1590 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Survodutide

placebo comparator: Placebo

Interventions

Survodutide

Subcutaneous injection, pre-filled syringe

Placebo matching survodutide

Subcutaneous injection, pre-filled syringe

Primary outcome measure

  • Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH [ Time Frame: up to 4.5 years. ]

Central Contacts and Locations

Central contacts

Locations

The Institute for Liver Health II DBA Arizona Clinical Trials

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Scottsdale Medical Specialists, Ltd

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Adobe Clinical Research, LLC

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Arizona Liver Health - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Hope Clinical Research

Recruiting

Canoga Park, California, United States, 91303

Contacts

Velocity Clinical Research-Chula Vista

Recruiting

Chula Vista, California, United States, 91911

Contacts

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Contacts

ARK Clinical Research

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Velocity Clinical Research-Huntington Park

Recruiting

Huntington Park, California, United States, 90255

Contacts

310 Clinical Research

Recruiting

Inglewood, California, United States, 90301

Contacts

Velocity Clinical Research, San Diego

Recruiting

La Mesa, California, United States, 91942

Contacts

Om Research, LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Clinnova Research Solutions

Recruiting

Orange, California, United States, 92868

Contacts

Fomat Medical Research

Recruiting

Oxnard, California, United States, 93030

Contacts

Cadena Care Institute, LLC

Recruiting

Poway, California, United States, 92064

Contacts

Ficramed Research Institute

Recruiting

Poway, California, United States, 92064

Contacts

Inland Empire Clinical Trials, LLC

Recruiting

Rialto, California, United States, 92377

Contacts

Metro Clinical Trials

Recruiting

San Bernardino, California, United States, 92404

Contacts

Acclaim Clinical Research

Recruiting

San Diego, California, United States, 92120

Contacts

Future Innovative Treatments

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

South Denver Gastroenterology PC

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Connecticut Gastroenterology Clinical Research Foundation

Recruiting

Bristol, Connecticut, United States, 06010

Contacts

Synergy Healthcare

Recruiting

Bradenton, Florida, United States, 34209

Contacts

Synergy Healthcare of Tampa

Recruiting

Brandon, Florida, United States, 33511

Contacts

Access research Institute

Recruiting

Brooksville, Florida, United States, 34613

Contacts

Hi Tech and Global Research, LLC

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Cenara Clinical Research

Recruiting

Cutler Bay, Florida, United States, 33189

Contacts

Covenant Metabolic Specialists, LLC - Fort Myers

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Neoclinical Research

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Evolution Clinical Trials

Recruiting

Hialeah Gardens, Florida, United States, 33016

Contacts

Global Research Associates

Recruiting

Homestead, Florida, United States, 33030

Contacts

Lake Center for Clinical Research

Recruiting

Lady Lake, Florida, United States, 32159

Contacts

Research Associates of South Florida, LLC

Recruiting

Miami, Florida, United States, 33134

Contacts

Optimus U Corporation-Miami-69452

Recruiting

Miami, Florida, United States, 33135

Contacts

Schiff Center Liver Diseases

Recruiting

Miami, Florida, United States, 33136

Contacts

BioMed Research & Medical Center

Recruiting

Miami, Florida, United States, 33156

Contacts

MplusM - Century Research

Recruiting

Miami, Florida, United States, 33173

Contacts

ECIR Miami Holdings LLC dba IMIC

Recruiting

Miami, Florida, United States, 33176

Contacts

Entrust Clinical Research

Recruiting

Miami, Florida, United States, 33176

Contacts

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Advanced Research Institute

Recruiting

New Port Richey, Florida, United States, 34653

Contacts

Charter Research

Recruiting

Orlando, Florida, United States, 32803

Contacts

OMEGA Research Group

Recruiting

Orlando, Florida, United States, 32808

Contacts

Endoscopic Research, Inc

Recruiting

Orlando, Florida, United States, 32828

Contacts

Innovation Medical Research Center

Recruiting

Palmetto Bay, Florida, United States, 33157

Contacts

MplusM - Best Choice Medical and Research Service

Recruiting

Pembroke Pines, Florida, United States, 33024

Contacts

Covenant Metabolic Specialist, LLC - Riverview

Recruiting

Riverview, Florida, United States, 33578

Contacts

Global Clinical Professionals

Recruiting

St. Petersburg, Florida, United States, 33714

Contacts

International Center for Research

Recruiting

Tampa, Florida, United States, 33618

Contacts

Charter Research

Recruiting

The Villages, Florida, United States, 32162

Contacts

Covenant Metabolic Specialists, LLC - University Park

Recruiting

University Park, Florida, United States, 34201

Contacts

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Florida Medical Clinic, P.A.

Recruiting

Zephyrhills, Florida, United States, 33542

Contacts

Piedmont Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Gastroenterology Associates of Central Georgia

Recruiting

Macon, Georgia, United States, 31201

Contacts

EmVenio Research Center at Prime Healthcare - Riverdale

Recruiting

Riverdale, Georgia, United States, 30274

Contacts

ASHA Clinical Research - Munster, LLC

Recruiting

Hammond, Indiana, United States, 46324

Contacts

Digestive Research Alliance of Michiana

Recruiting

South Bend, Indiana, United States, 46635

Contacts

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50265

Contacts

Delta Research Partners, LLC

Recruiting

Bastrop, Louisiana, United States, 71220

Contacts

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Louisiana Research Center, LLC

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Clinical Research Institute of Michigan, LLC

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

West Michigan Clinical Research Center

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

MNGI Digestive Health, PA

Recruiting

Minneapolis, Minnesota, United States, 55413

Contacts

ObjectiveHealth-GI Associates Research

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Kansas City Research Institute

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Jubilee Clinical Research, Inc

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Excel Clinical Research

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Clinical Research of South Nevada

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

IMA Clinical Research-Warren-69742

Recruiting

Warren Township, New Jersey, United States, 07059

Contacts

NewYork-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Contacts

Basil Clinical

Recruiting

Laurelton, New York, United States, 11413

Contacts

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Coastal Research Institute, LLC

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Carolina Researche

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

M3 Wake Research, Inc.

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Great Lakes Gastroenterology

Recruiting

Mentor, Ohio, United States, 44060

Contacts

ObjectiveHealth-DSI Research - Springboro, LLC

Recruiting

Springboro, Ohio, United States, 45066

Contacts

Northshore Gastroenterology Research

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Options Health Research

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

US Digestive Health

Recruiting

Flourtown, Pennsylvania, United States, 19031

Contacts

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

US Digestive Health

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

US Digestive Health

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

ObjectiveHealth-Columbia Digestive Health Research

Recruiting

Columbia, South Carolina, United States, 29204

Contacts

Palmetto Clinical Research

Recruiting

Summerville, South Carolina, United States, 29485

Contacts

ClinSearch, LLC

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Innovative Clinical Research

Recruiting

Clarksville, Tennessee, United States, 37040

Contacts

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Texas Clinical Research Institute, LLC

Recruiting

Arlington, Texas, United States, 76012

Contacts

IMA Clinical Research Austin

Recruiting

Austin, Texas, United States, 78745

Contacts

American Research Corporation - Austin

Recruiting

Austin, Texas, United States, 78757

Contacts

Pinnacle Clinical Research - Austin

Recruiting

Austin, Texas, United States, 78757

Contacts

Velocity Clinical Research, Austin

Recruiting

Austin, Texas, United States, 78759

Contacts

Pinnacle Clinical Research, LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

South Texas Research Institute - Brownsville

Recruiting

Brownsville, Texas, United States, 78520

Contacts

North Texas Research Institute - Dallas

Recruiting

Dallas, Texas, United States, 75150

Contacts

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

GI Alliance Research - Dallas

Recruiting

Dallas, Texas, United States, 75246

Contacts

Soma Clinical Trials

Recruiting

Denison, Texas, United States, 75020

Contacts

EmVenio Research Center at Prime Healthcare - Farmers Branch

Recruiting

Garden City, Texas, United States, 48135

Contacts

DHAT Reseach Institute

Recruiting

Garland, Texas, United States, 75044

Contacts

Pinnacle Clinical Research, LLC

Recruiting

Georgetown, Texas, United States, 78626

Contacts

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030-1608

Contacts

Biopharma Informatic, Inc. Research Center

Recruiting

Houston, Texas, United States, 77084

Contacts

Research Physicians Network

Recruiting

Houston, Texas, United States, 77089

Contacts

Epic Clinical Research

Recruiting

Lewisville, Texas, United States, 75057

Contacts

GI Alliance Research - Mansfield

Recruiting

Mansfield, Texas, United States, 76063

Contacts

Biopharma Informatic LLC

Recruiting

McAllen, Texas, United States, 78503

Contacts

Centex Studies, Inc.

Recruiting

McAllen, Texas, United States, 78504

Contacts

American Research Corporation at the Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78219

Contacts

HASresearch

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Velocity Clinical Research, Waco

Recruiting

Waco, Texas, United States, 76710

Contacts

Objective Health-Digestive Research of Central Texas

Recruiting

Waco, Texas, United States, 76712

Contacts

ObjectiveHealth-Digestive Health Research of North Texas

Recruiting

Wichita Falls, Texas, United States, 76301

Contacts

GI Select Health Research, LLC

Recruiting

Richmond, Virginia, United States, 23236

Contacts

Velocity Clinical Research, Seattle

Recruiting

Seattle, Washington, United States, 98105

Contacts

Velocity Clinical Research-Spokane-69716

Recruiting

Spokane, Washington, United States, 99218

Contacts

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Viable Clinical Research

Recruiting

Bridgewater, Nova Scotia, Canada, B4N 3N2

Contacts

Toronto Liver Centre

Recruiting

Toronto, Ontario, Canada, M6H 3M1

Contacts

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H3H 2R9

Contacts

Diex Recherche Québec

Recruiting

Québec, Canada, G1N 4V3

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-03.