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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Sponsor: Eli Lilly and Company
Summary
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
Official title: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4500
Start Date
2025-10-15
Completion Date
2032-08
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Tirzepatide
Administered SC
Retatrutide
Administered SC
Placebo
Administered SC
Locations (563)
MFA Clinical Research
Tuscaloosa, Alabama, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
Chandler, Arizona, United States
Spectrum Research Institute
Gilbert, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria
Peoria, Arizona, United States
Epic Medical Research-Sun City
Sun City, Arizona, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Tucson
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
Fresno Clinical Research Center
Fresno, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Orange County Research Center
Lake Forest, California, United States
Om Research LLC
Lancaster, California, United States
Ark Clinical Research
Long Beach, California, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, United States
United Medical Doctors - Murrieta
Murrieta, California, United States
Knowledge Research Center
Orange, California, United States
California Liver Research Center
Pasadena, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Medical Research Center of Connecticut
Hamden, Connecticut, United States
K2 Medical Research WINTER GARDEN
Clermont, Florida, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, United States
Care Access - Delray Beach
Delray Beach, Florida, United States
AMR Clinical
Doral, Florida, United States
Southwest General Healthcare Center
Fort Myers, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States
Health Awareness
Jupiter, Florida, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Tampa Bay Medical Research - Largo
Largo, Florida, United States
Evolution Clinical Trials
Miami, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
GI PROS Research
Naples, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Covenant Metabolic Specialists - Riverview
Riverview, Florida, United States
Care Access - St. Petersburg
St. Petersburg, Florida, United States
Care Access - Tamarac
Tamarac, Florida, United States
Covenant Metabolic Specialists, LLC
University Park, Florida, United States
Southeast Clinical Research Center
Dalton, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Deaconess Clinic- Gateway
Newburgh, 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
AMR Clinical
El Dorado, Kansas, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
AMR Clinical
Lexington, Kentucky, United States
Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Care Access - New Iberia
New Iberia, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Delta Research Partners of West Monroe
West Monroe, Louisiana, United States
Mercy Medical Center - Baltimore
Baltimore, Maryland, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, United States
Lucida Clinical Trials
New Bedford, Massachusetts, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States
Great Lakes Research Institute
Southfield, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
MNGI Digestive Health
Minneapolis, Minnesota, United States
GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi, United States
AMR Clinical
Kansas City, Missouri, United States
Jubilee Clinical Research NV. LLC
Las Vegas, Nevada, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Tandem Clinical Research - Freehold
Freehold, New Jersey, United States
Atlantic Health System Morristown Medical Center
Morristown, New Jersey, United States
Clinical Research of Philadelphia
Pennington, New Jersey, United States
The Cognitive and Research Center of New Jersey - Ridgewood
Ridgewood, New Jersey, United States
IMA Clinical Research Warren
Warren Township, New Jersey, United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
IMA Clinical Research Manhattan
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
Care Access - Yonkers
Yonkers, New York, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Akron Gastro Research
Akron, Ohio, United States
Dayton Gastroenterology - Beavercreek
Beavercreek, Ohio, United States
Clinical Research Institute of Ohio - Brooklyn
Brooklyn, Ohio, United States
CRIOH
Westlake, Ohio, United States
US Digestive Health - Flourtown
Flourtown, Pennsylvania, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
US Digestive Health - Wyomissing
Wyomissing, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Columbia Digestive Health Research
Columbia, South Carolina, United States