What this trial means for you
This study is recruiting now at 125 US sites. It's studying Survodutide, Placebo matching survodutide for metabolic dysfunction associated steatohepatitis.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
Arizona
- The Institute for Liver Health II DBA Arizona Clinical Trials — Peoria · Recruiting now
- Scottsdale Medical Specialists, Ltd — Scottsdale · Recruiting now
- Adobe Clinical Research, LLC — Tucson · Opening soon
- Arizona Liver Health - Tucson — Tucson · Recruiting now
- Del Sol Research Management, LLC — Tucson · Recruiting now
California
- Hope Clinical Research — Canoga Park · Recruiting now
- Velocity Clinical Research-Chula Vista — Chula Vista · Recruiting now
- Southern California Research Center — Coronado · Recruiting now
- ARK Clinical Research — Fountain Valley · Recruiting now
- Velocity Clinical Research-Huntington Park — Huntington Park · Opening soon
- 310 Clinical Research — Inglewood · Recruiting now
- Velocity Clinical Research, San Diego — La Mesa · Opening soon
- Om Research, LLC — Lancaster · Recruiting now
- Catalina Research Institute, LLC — Montclair · Opening soon
- Clinnova Research Solutions — Orange · Recruiting now
- Fomat Medical Research — Oxnard · Recruiting now
- Cadena Care Institute, Llc — Poway · Recruiting now
- Ficramed Research Institute — Poway · Opening soon
- Inland Empire Clinical Trials, LLC — Rialto · Recruiting now
- Metro Clinical Trials — San Bernardino · Opening soon
- Acclaim Clinical Research — San Diego · Recruiting now
Colorado
- Future Innovative Treatments — Colorado Springs · Recruiting now
- South Denver Gastroenterology PC — Englewood · Recruiting now
Connecticut
- Connecticut Gastroenterology Clinical Research Foundation — Bristol · Recruiting now
Florida
- Synergy Healthcare — Brandon · Recruiting now
- Access research Institute — Brooksville · Recruiting now
- Hi Tech and Global Research, LLC — Coral Gables · Recruiting now
- Cenara Clinical Research — Cutler Bay · Recruiting now
- Covenant Metabolic Specialists, LLC - Fort Myers — Fort Myers · Recruiting now
- Neoclinical Research — Hialeah · Recruiting now
- Evolution Clinical Trials — Hialeah Gardens · Recruiting now
- Global Research Associates — Homestead · Recruiting now
- Lake Center for Clinical Research — Lady Lake · Recruiting now
- Research Associates of South Florida, LLC — Miami · Recruiting now
- Optimus U Corporation-Miami-69452 — Miami · Recruiting now
- Schiff Center Liver Diseases — Miami · Recruiting now
- BioMed Research & Medical Center — Miami · Recruiting now
- MplusM - Century Research — Miami · Recruiting now
- ECIR Miami Holdings LLC dba IMIC — Miami · Recruiting now
- Entrust Clinical Research — Miami · Recruiting now
- Floridian Clinical Research — Miami Lakes · Recruiting now
- Advanced Research Institute — New Port Richey · Recruiting now
- Charter Research — Orlando · Recruiting now
- Omega Research Orlando, LLC — Orlando · Recruiting now
- Endoscopic Research, Inc — Orlando · Recruiting now
- Innovation Medical Research Center — Palmetto Bay · Recruiting now
- MplusM - Best Choice Medical and Research Service — Pembroke Pines · Recruiting now
- Covenant Metabolic Specialist, LLC - Riverview — Riverview · Opening soon
- Synergy Healthcare — St. Petersburg · Recruiting now
- Global Clinical Professionals — St. Petersburg · Recruiting now
- International Center for Research — Tampa · Recruiting now
- Charter Research — The Villages · Recruiting now
- Covenant Metabolic Specialists, LLC - University Park — University Park · Recruiting now
- Conquest Research — Winter Park · Recruiting now
- Florida Medical Clinic, P.A. — Zephyrhills · Recruiting now
Georgia
- Piedmont Hospital — Atlanta · Opening soon
- Gastroenterology Associates of Central Georgia — Macon · Recruiting now
- EmVenio Research Center at Prime Healthcare - Riverdale — Riverdale · Recruiting now
Indiana
- ASHA Clinical Research - Munster, LLC — Hammond · Recruiting now
- Digestive Research Alliance of Michiana — South Bend · Recruiting now
Iowa
- Iowa Diabetes and Endocrinology Research Center — West Des Moines · Recruiting now
Louisiana
- Tandem Clinical Research — Marrero · Recruiting now
- Delta Research Partners, LLC — Monroe · Recruiting now
- Louisiana Research Center, LLC — Shreveport · Recruiting now
Michigan
- Clinical Research Institute of Michigan, LLC — Clinton Township · Recruiting now
- West Michigan Clinical Research Center — Wyoming · Opening soon
Minnesota
- MNGI Digestive Health, PA — Minneapolis · Recruiting now
Missouri
- ObjectiveHealth-GI Associates Research — Columbia · Recruiting now
- Kansas City Research Institute — Kansas City · Recruiting now
Nebraska
- University of Nebraska Medical Center — Omaha · Recruiting now
Nevada
- Jubilee Clinical Research, Inc — Las Vegas · Recruiting now
- Excel Clinical Research — Las Vegas · Recruiting now
- Clinical Research of South Nevada — Las Vegas · Recruiting now
New Jersey
- IMA Clinical Research-Warren-69742 — Warren Township · Recruiting now
New York
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn · Opening soon
- Basil Clinical — Laurelton · Recruiting now
- Icahn School of Medicine at Mount Sinai — New York · Opening soon
- University of Rochester Medical Center — Rochester · Recruiting now
North Carolina
- Coastal Research Institute, LLC — Fayetteville · Recruiting now
- Carolina Researche — Greenville · Recruiting now
- M3 Wake Research, Inc. — Raleigh · Recruiting now
Ohio
- The Ohio State University Wexner Medical Center — Columbus · Recruiting now
- Great Lakes Gastroenterology Research, LLC — Mentor · Opening soon
- ObjectiveHealth-DSI Research - Springboro, LLC — Springboro · Recruiting now
- Northshore Gastroenterology Research — Westlake · Recruiting now
Oklahoma
- Options Health Research — Tulsa · Recruiting now
Pennsylvania
- US Digestive Health — Flourtown · Recruiting now
- Penn State Milton S. Hershey Medical Center — Hershey · Recruiting now
- US Digestive Health — Lancaster · Recruiting now
- US Digestive Health — Wyomissing · Recruiting now
South Carolina
- ObjectiveHealth-Columbia Digestive Health Research — Columbia · Recruiting now
- Palmetto Clinical Research — Summerville · Recruiting now
Tennessee
- ClinSearch, LLC — Chattanooga · Recruiting now
- Innovative Clinical Research — Clarksville · Recruiting now
- Vanderbilt University Medical Center — Nashville · Opening soon
Texas
- Texas Clinical Research Institute, LLC — Arlington · Recruiting now
- IMA Clinical Research Austin — Austin · Recruiting now
- American Research Corporation - Austin — Austin · Recruiting now
- Pinnacle Clinical Research - Austin — Austin · Recruiting now
- Velocity Clinical Research, Austin — Austin · Recruiting now
- Pinnacle Clinical Research, LLC — Bellaire · Recruiting now
- South Texas Research Institute - Brownsville — Brownsville · Recruiting now
- North Texas Research Institute - Dallas — Dallas · Recruiting now
- Zenos Clinical Research — Dallas · Recruiting now
- GI Alliance Research - Dallas — Dallas · Recruiting now
- Soma Clinical Trials — Denison · Recruiting now
- EmVenio Research Center at Prime Healthcare - Farmers Branch — Garden City · Opening soon
- DHAT Reseach Institute — Garland · Recruiting now
- Pinnacle Clinical Research, LLC — Georgetown · Recruiting now
- Ben Taub General Hospital — Houston · Recruiting now
- Biopharma Informatic, Inc. Research Center — Houston · Recruiting now
- Research Physicians Network — Houston · Recruiting now
- Epic Clinical Research — Lewisville · Opening soon
- GI Alliance Research - Mansfield — Mansfield · Recruiting now
- Biopharma Informatic LLC — McAllen · Recruiting now
- Centex Studies, Inc. — McAllen · Recruiting now
- American Research Corporation at the Texas Liver Institute — San Antonio · Recruiting now
- Brooke Army Medical Center — San Antonio · Opening soon
- HASresearch — San Antonio · Recruiting now
- Velocity Clinical Research, Waco — Waco · Recruiting now
- Objective Health-Digestive Research of Central Texas — Waco · Recruiting now
- ObjectiveHealth-Digestive Health Research of North Texas — Wichita Falls · Recruiting now
Virginia
- GI Select Health Research LLC — Richmond · Recruiting now
Washington
- Velocity Clinical Research, Seattle — Seattle · Recruiting now
- Velocity Clinical Research-Spokane-69716 — Spokane · Opening soon
View the official record on ClinicalTrials.gov →
Follow this trial
Get an email when our monthly digest covers enrollment changes and results for trials like this one.
Newsletter signup launches soon. (Site owner: set PUBLIC_BUTTONDOWN_USERNAME in
.env to activate this form.)