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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

NCT07165028

This study is recruiting at 137 US sites in 34 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Eli Lilly and Company
Last updated on ClinicalTrials.gov
October 8, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Alabama · 1

  • MFA Clinical Research · Tuscaloosa, AL

Arizona · 6

  • The Institute for Liver Health II dba Arizona Clinical Trials - Chandler · Chandler, AZ
  • Spectrum Research Institute · Gilbert, AZ
  • The Institute for Liver Health II dba Arizona Liver Health - Peoria · Peoria, AZ
  • Epic Medical Research-Sun City · Sun City, AZ
  • Del Sol Research Management, LLC · Tucson, AZ
  • The Institute for Liver Health II dba Arizona Clinical Trials - Tucson · Tucson, AZ

Arkansas · 1

  • Arkansas Gastroenterology - North Little Rock · North Little Rock, AR

California · 14

  • San Fernando Valley Health Institute · Canoga Park, CA
  • Ark Clinical Research - Fountain Valley · Fountain Valley, CA
  • Fresno Clinical Research Center · Fresno, CA
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) · La Jolla, CA
  • Orange County Research Center · Lake Forest, CA
  • Om Research LLC · Lancaster, CA
  • Ark Clinical Research · Long Beach, CA
  • Los Angeles Institute for Metabolic Research · Los Angeles, CA
  • United Medical Doctors - Murrieta · Murrieta, CA
  • Knowledge Research Center · Orange, CA
  • California Liver Research Center · Pasadena, CA
  • Artemis Institute for Clinical Research · Riverside, CA
  • Medical Associates Research Group · San Diego, CA
  • Quest Clinical Research · San Francisco, CA

Colorado · 2

  • University of Colorado Anschutz Medical Campus · Aurora, CO
  • South Denver Gastroenterology · Englewood, CO

Connecticut · 1

  • Medical Research Center of Connecticut · Hamden, CT

Florida · 23

  • K2 Medical Research WINTER GARDEN · Clermont, FL
  • K2 Medical Research - Daytona Beach · Daytona Beach, FL
  • Care Access - Delray Beach · Delray Beach, FL
  • AMR Clinical · Doral, FL
  • Southwest General Healthcare Center · Fort Myers, FL
  • University of Florida College of Medicine · Gainesville, FL
  • Encore Medical Research · Hollywood, FL
  • Nature Coast Clinical Research - Inverness · Inverness, FL
  • Encore Borland-Groover Clinical Research · Jacksonville, FL
  • Health Awareness · Jupiter, FL
  • K2 MEDICAL Research THE VILLAGES · Lady Lake, FL
  • Florida Research Institute · Lakewood Rch, FL
  • Tampa Bay Medical Research - Largo · Largo, FL
  • Evolution Clinical Trials · Miami, FL
  • Floridian Clinical Research, LLC · Miami Lakes, FL
  • GI PROS Research · Naples, FL
  • Charter Research - Orlando · Orlando, FL
  • Headlands Research Orlando · Orlando, FL
  • Progressive Medical Research · Port Orange, FL
  • Covenant Metabolic Specialists - Riverview · Riverview, FL
  • Care Access - St. Petersburg · St. Petersburg, FL
  • Care Access - Tamarac · Tamarac, FL
  • Covenant Metabolic Specialists, LLC · University Park, FL

Georgia · 3

  • Southeast Clinical Research Center · Dalton, GA
  • Gastrointestinal Specialists of Georgia · Marietta, GA
  • Rophe Adult and Pediatric Medicine/SKYCRNG · Union City, GA

Indiana · 4

  • Indiana University Health University Hospital · Indianapolis, IN
  • Gastroenterology Health Partners · New Albany, IN
  • Deaconess Clinic- Gateway · Newburgh, IN
  • Digestive Research Alliance of Michiana · South Bend, IN

Iowa · 1

  • Iowa Diabetes and Endocrinology Research Center · West Des Moines, IA

Kansas · 3

  • AMR Clinical · El Dorado, KS
  • Johnson County Clinical Trials · Lenexa, KS
  • Cotton O'Neil Digestive Health Center · Topeka, KS

Kentucky · 1

  • AMR Clinical · Lexington, KY

Louisiana · 5

  • Delta Research Partners of Bastrop, LLC · Bastrop, LA
  • Tandem Clinical Research · Marrero, LA
  • Care Access - New Iberia · New Iberia, LA
  • Louisiana Research Center · Shreveport, LA
  • Delta Research Partners of West Monroe · West Monroe, LA

Maryland · 2

  • Mercy Medical Center - Baltimore · Baltimore, MD
  • Capital Digestive Care - Chevy Chase · Chevy Chase, MD

Massachusetts · 1

  • Lucida Clinical Trials · New Bedford, MA

Michigan · 3

  • Clinical Research Institute of Michigan, LLC · Clinton Township, MI
  • Great Lakes Research Institute · Southfield, MI
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division · Troy, MI

Minnesota · 1

  • MNGI Digestive Health · Minneapolis, MN

Mississippi · 1

  • GI Associates - GIA and Endoscopy Center - Flowood · Flowood, MS

Missouri · 1

  • AMR Clinical · Kansas City, MO

Nevada · 2

  • Excel Clinical Research, LLC · Las Vegas, NV
  • Jubilee Clinical Research NV. LLC · Las Vegas, NV

New Jersey · 4

  • Tandem Clinical Research - Freehold · Freehold, NJ
  • Clinical Research of Philadelphia · Pennington, NJ
  • The Cognitive and Research Center of New Jersey - Ridgewood · Ridgewood, NJ
  • IMA Clinical Research Warren · Warren Township, NJ

New Mexico · 1

  • Southwest Gastroenterology Associates · Albuquerque, NM

New York · 5

  • Research Foundation of SUNY - University of Buffalo · Buffalo, NY
  • IMA Clinical Research Manhattan · New York, NY
  • New York Gastroenterology Associates · New York, NY
  • NYU Langone Health · New York, NY
  • Care Access - Yonkers · Yonkers, NY

North Carolina · 3

  • Duke University - Main Hospital and Clinics · Durham, NC
  • Monroe Biomedical Research · Monroe, NC
  • Carteret Medical Group · Morehead City, NC

Ohio · 3

  • Akron Gastro Research · Akron, OH
  • Dayton Gastroenterology - Beavercreek · Beavercreek, OH
  • CRIOH · Westlake, OH

Pennsylvania · 3

  • US Digestive Health - Flourtown · Flourtown, PA
  • Penn Medicine: University of Pennsylvania Health System · Philadelphia, PA
  • US Digestive Health - Wyomissing · Wyomissing, PA

Rhode Island · 1

  • University Gastroenterology · Providence, RI

South Carolina · 1

  • Columbia Digestive Health Research · Columbia, SC

Tennessee · 2

  • Galen Medical Group - Galen Hepatology · Chattanooga, TN
  • Gastro One (Walnut Run Road) · Cordova, TN

Texas · 29

  • American Research Corporation · Austin, TX
  • IMA Clinical Research Austin · Austin, TX
  • Pinnacle Clinical Research · Austin, TX
  • Bellaire Clinical Research · Bellaire, TX
  • Headlands Horizons, LLC dba Headlands Research-Brownsville · Brownsville, TX
  • South Texas Research Institute - Brownsville · Brownsville, TX
  • Soma Clinical Trials · Denison, TX
  • Epic Medical Research - DeSoto · DeSoto, TX
  • South Texas Research Institute · Edinburg, TX
  • Dallas Research Institute · Farmers Branch, TX
  • Care United Research, LLC · Forney, TX
  • GI Alliance - Fort Worth · Fort Worth, TX
  • Biopharma Informatic, LLC · Houston, TX
  • Care Access - Houston · Houston, TX
  • Houston Research Institute · Houston, TX
  • HRI- Medical Center · Houston, TX
  • Research Physicians Network, LLC · Houston, TX
  • Biopharma Informatic, LLC · McAllen, TX
  • DHR Health Institute for Research and Development (Administrative Office & Laboratory) · McAllen, TX
  • Southern Endocrinology Associates · Mesquite, TX
  • HRI Pasadena · Pasadena, TX
  • American Research Corporation at Texas Liver Institute · San Antonio, TX
  • Clinical Trials of Texas, LLC dba Flourish Research · San Antonio, TX
  • IMA Clinical Research San Antonio · San Antonio, TX
  • Consano Clinical Research, LLC · Shavano Park, TX
  • GI Alliance - Southlake · Southlake, TX
  • Houston Research Institute (HRI) - Sugar Land · Sugar Land, TX
  • Texas Valley Clinical Research · Weslaco, TX
  • Medrasa Clinical Research · Wylie, TX

Utah · 2

  • Care Access - Ogden · Ogden, UT
  • Advanced Research Institute - Sandy · Sandy City, UT

Virginia · 3

  • Eximia Research - Norfolk · Norfolk, VA
  • Richmond Veterans Affairs Medical Center (Richmond VA Medical Center) · Richmond, VA
  • Gastroenterology Consultants of Southwest Virginia · Roanoke, VA

Washington · 3

  • Washington Gastroenterology - Bellevue · Bellevue, WA
  • UW Medicine Diabetes Institute · Seattle, WA
  • Washington Gastroenterology - Tacoma · Tacoma, WA

West Virginia · 1

  • CAMC Health Education and Research Institute Inc · Charleston, WV

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.