Recruiting
Phase 3

Retatrutide & Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT07165028

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Retatrutide

Placebo

Study Details

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Study ID

NCT07165028

Start date

Oct 15, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2032

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have liver fat content ≥8%
  • Have ELF score of ≥9 and ≤10.8 at screening
  • Have VCTE LSM ≥10 kilopascal (kPa) and <20 kPa at screening

Exclusion Criteria:

  • Have any other type of liver disease other than MASLD
  • Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)
  • Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
  • Have lost more than 11 pounds within the 3 months prior to screening
  • Have a hemoglobin A1c (HbA1c) greater than 10%
  • Have type 1 diabetes

Study Design

Enrollment

4500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide (TZ01)

Participants will receive tirzepatide subcutaneously (SC)

placebo comparator: Placebo (TZ01)

Participants will receive placebo SC

experimental: Retatrutide (RT01)

Participants will receive retatrutide SC

placebo comparator: Placebo (RT01)

Participants will receive placebo SC

Interventions

Tirzepatide

Administered SC

Retatrutide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO) [ Time Frame: Baseline up to Study Completion (about 224 weeks) ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

MFA Clinical Research

Recruiting

Tuscaloosa, Alabama, United States, 35405

Contacts

Principal Investigator:

Adisesha Reddy

The Institute for Liver Health II dba Arizona Clinical Trials - Chandler

Recruiting

Chandler, Arizona, United States, 85224

Principal Investigator:

Yessica Sachdeva

Spectrum Research Institute

Recruiting

Gilbert, Arizona, United States, 85297

Principal Investigator:

Donna DeSantis

The Institute for Liver Health II dba Arizona Liver Health - Peoria

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Principal Investigator:

Justin Reynolds

Epic Medical Research-Sun City

Recruiting

Sun City, Arizona, United States, 85351

Principal Investigator:

Rachel Greatwood

The Institute for Liver Health II dba Arizona Clinical Trials - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Principal Investigator:

Anita Kohli

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

Contacts

Principal Investigator:

Bassel Kisso

Arkansas Gastroenterology - North Little Rock

Recruiting

North Little Rock, Arkansas, United States, 72117

Principal Investigator:

Samuel Dunn

San Fernando Valley Health Institute

Recruiting

Canoga Park, California, United States, 91304

Contacts

Principal Investigator:

Jeffrey London

Ark Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Mark Leibowitz

Fresno Clinical Research Center

Recruiting

Fresno, California, United States, 93720

Contacts

Principal Investigator:

Muhammad Sheikh

UCSD - Altman Clinical and Translational Research Institute (ACTRI)

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Rohit Loomba

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Contacts

Principal Investigator:

JOEL NEUTEL

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

Contacts

Principal Investigator:

Jatinder Pruthi

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Contacts

Principal Investigator:

Apinya Vutikullird

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

Contacts

Principal Investigator:

Juan Frias

United Medical Doctors - Murrieta

Recruiting

Murrieta, California, United States, 92563

Contacts

Principal Investigator:

John Jong Bae Hong

Knowledge Research Center

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Alaa Abousaif

California Liver Research Center

Recruiting

Pasadena, California, United States, 91105

Contacts

Principal Investigator:

Edward Mena

Artemis Institute for Clinical Research

Recruiting

Riverside, California, United States, 92503

Contacts

Principal Investigator:

Jack Vu

Medical Associates Research Group

Recruiting

San Diego, California, United States, 92123

Contacts

Principal Investigator:

Cainan Foltz

Quest Clinical Research

Recruiting

San Francisco, California, United States, 94115

Contacts

Principal Investigator:

Maurizio Bonacini

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Neda Rasouli

South Denver Gastroenterology

Recruiting

Englewood, Colorado, United States, 80113

Principal Investigator:

Marcelo Kugelmas

Medical Research Center of Connecticut

Recruiting

Hamden, Connecticut, United States, 06518

Principal Investigator:

Paul Feuerstadt

K2 Medical Research WINTER GARDEN

Recruiting

Clermont, Florida, United States, 34711

Contacts

Principal Investigator:

Beatriz Colon

K2 Medical Research - Daytona Beach

Recruiting

Daytona Beach, Florida, United States, 32114

Principal Investigator:

Joshua Eisenhut

Care Access - Delray Beach

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Principal Investigator:

Sudhir Bansal

AMR Clinical

Recruiting

Doral, Florida, United States, 33172

Principal Investigator:

Abid Chaudhry

Southwest General Healthcare Center

Recruiting

Fort Myers, Florida, United States, 33907

Contacts

Principal Investigator:

Jose Rodriguez

University of Florida College of Medicine

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Kenneth Cusi

Encore Medical Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

Principal Investigator:

Rodolfo Perez

Nature Coast Clinical Research - Inverness

Recruiting

Inverness, Florida, United States, 34452

Contacts

Principal Investigator:

Paul Hellstern

Encore Borland-Groover Clinical Research

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Principal Investigator:

Nikhil Kapila

Health Awareness

Recruiting

Jupiter, Florida, United States, 33458

Principal Investigator:

Mitchell Davis

K2 MEDICAL Research THE VILLAGES

Recruiting

Lady Lake, Florida, United States, 32159

Contacts

Principal Investigator:

Craig Curtis

Florida Research Institute

Recruiting

Lakewood Rch, Florida, United States, 34211

Contacts

Principal Investigator:

Manuel Rodriguez

Tampa Bay Medical Research - Largo

Recruiting

Largo, Florida, United States, 33777

Contacts

Principal Investigator:

Sureka Bollepalli

Evolution Clinical Trials

Recruiting

Miami, Florida, United States, 33122-1722

Contacts

Principal Investigator:

Gilberto Perez

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016-1518

Contacts

Principal Investigator:

William Sanchez

GI PROS Research

Recruiting

Naples, Florida, United States, 34102

Contacts

Principal Investigator:

Raymond Phillips

Charter Research - Orlando

Recruiting

Orlando, Florida, United States, 32803

Principal Investigator:

Mary Quarterman

Headlands Research Orlando

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Uzma Khan

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Principal Investigator:

Bhanu Visvalingam

Covenant Metabolic Specialists - Riverview

Recruiting

Riverview, Florida, United States, 33578

Contacts

Principal Investigator:

Guy Neff

Care Access - St. Petersburg

Recruiting

St. Petersburg, Florida, United States, 33710

Contacts

Principal Investigator:

Gigi Lefebvre

Care Access - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Principal Investigator:

Brad Lipson

Covenant Metabolic Specialists, LLC

Recruiting

University Park, Florida, United States, 34201

Contacts

Principal Investigator:

Guy Neff

Southeast Clinical Research Center

Recruiting

Dalton, Georgia, United States, 30720

Contacts

Principal Investigator:

Pablo Perez

Gastrointestinal Specialists of Georgia

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Principal Investigator:

Aasim Sheikh

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Contacts

Principal Investigator:

Dwight Blake

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Raj Vuppalanchi

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Principal Investigator:

Jonathan Obert

Deaconess Clinic- Gateway

Recruiting

Newburgh, Indiana, United States, 47630

Contacts

Principal Investigator:

Mia Hindi

Digestive Research Alliance of Michiana

Recruiting

South Bend, Indiana, United States, 46635

Contacts

Principal Investigator:

Pankaj Patel

Iowa Diabetes and Endocrinology Research Center

Recruiting

West Des Moines, Iowa, United States, 50266

Principal Investigator:

Amy Keller

AMR Clinical

Recruiting

El Dorado, Kansas, United States, 67042

Contacts

Principal Investigator:

Michael Rausch

Johnson County Clinical Trials

Recruiting

Lenexa, Kansas, United States, 66219

Principal Investigator:

Thomas Kreamer

Cotton O'Neil Digestive Health Center

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Principal Investigator:

Curtis Baum

AMR Clinical

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Principal Investigator:

Mark Adams

Delta Research Partners of Bastrop, LLC

Recruiting

Bastrop, Louisiana, United States, 71220

Contacts

Principal Investigator:

Bal Raj Bhandari

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Principal Investigator:

Gary Reiss

Care Access - New Iberia

Recruiting

New Iberia, Louisiana, United States, 70560

Contacts

Principal Investigator:

Son Nguyen

Louisiana Research Center

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Principal Investigator:

John Provenza

Delta Research Partners of West Monroe

Recruiting

West Monroe, Louisiana, United States, 71291

Principal Investigator:

Clarence Dunn

Mercy Medical Center - Baltimore

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Principal Investigator:

Paul Thuluvath

Capital Digestive Care - Chevy Chase

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Principal Investigator:

Mohammed Ali

Lucida Clinical Trials

Recruiting

New Bedford, Massachusetts, United States, 02740

Principal Investigator:

Jason Reich

Clinical Research Institute of Michigan, LLC

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Principal Investigator:

Kyle Antosiek

Great Lakes Research Institute

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Principal Investigator:

Derrick Williamson

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Recruiting

Troy, Michigan, United States, 48098

Contacts

Principal Investigator:

Neil Fraser

MNGI Digestive Health

Recruiting

Minneapolis, Minnesota, United States, 55413

Principal Investigator:

Ibrahim Hanouneh

GI Associates - GIA and Endoscopy Center - Flowood

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Principal Investigator:

Ralph Vance

AMR Clinical

Recruiting

Kansas City, Missouri, United States, 64114

Principal Investigator:

Martha Fanning

Jubilee Clinical Research NV. LLC

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Principal Investigator:

Elliot Shin

Excel Clinical Research, LLC

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Principal Investigator:

Robby Quintos

Tandem Clinical Research - Freehold

Recruiting

Freehold, New Jersey, United States, 07728

Principal Investigator:

Colin Brown

Clinical Research of Philadelphia

Recruiting

Pennington, New Jersey, United States, 08534

Contacts

Principal Investigator:

Taher Modarressi

The Cognitive and Research Center of New Jersey - Ridgewood

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Principal Investigator:

Ritu Suri

IMA Clinical Research Warren

Recruiting

Warren Township, New Jersey, United States, 07059

Principal Investigator:

Nancy Phillips

Southwest Gastroenterology Associates

Recruiting

Albuquerque, New Mexico, United States, 87109

Principal Investigator:

Antoine Jakiche

Research Foundation of SUNY - University of Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Principal Investigator:

Ajay Chaudhuri

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Ira Jacobson

IMA Clinical Research Manhattan

Recruiting

New York, New York, United States, 10036

Principal Investigator:

Samar Hameed

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

Principal Investigator:

Jennifer Leong

Care Access - Yonkers

Recruiting

Yonkers, New York, United States, 10701

Principal Investigator:

Peter Wayne

Duke University - Main Hospital and Clinics

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Anastasia-Stefania Alexopoulos

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Carteret Medical Group

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Principal Investigator:

Mary Lawrence

Akron Gastro Research

Recruiting

Akron, Ohio, United States, 44320

Principal Investigator:

Ganesh Veerappan

CRIOH

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Principal Investigator:

Naim Alkhouri

US Digestive Health - Flourtown

Recruiting

Flourtown, Pennsylvania, United States, 19031

Contacts

Principal Investigator:

Victor Araya

Penn Medicine: University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Ethan Weinberg

US Digestive Health - Wyomissing

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Contacts

Principal Investigator:

Nirav Shah

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02905

Principal Investigator:

Eric Newton

Columbia Digestive Health Research

Recruiting

Columbia, South Carolina, United States, 29204

Principal Investigator:

Edward Kimbrough

Galen Medical Group - Galen Hepatology

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

Principal Investigator:

Chirag Patel

Gastro One (Walnut Run Road)

Recruiting

Cordova, Tennessee, United States, 38018

Principal Investigator:

Ziad Younes

IMA Clinical Research Austin

Recruiting

Austin, Texas, United States, 78745

Contacts

Principal Investigator:

Nomita Kim

American Research Corporation

Recruiting

Austin, Texas, United States, 78757

Contacts

Principal Investigator:

Carmen Landaverde

Pinnacle Clinical Research

Recruiting

Austin, Texas, United States, 78757

Contacts

Principal Investigator:

Rohit Puskoor

Bellaire Clinical Research

Recruiting

Bellaire, Texas, United States, 77401

Principal Investigator:

Michael Hansen

South Texas Research Institute - Brownsville

Recruiting

Brownsville, Texas, United States, 78520

Contacts

Principal Investigator:

Dimple Desai

Headlands Horizons, LLC dba Headlands Research-Brownsville

Recruiting

Brownsville, Texas, United States, 78526

Principal Investigator:

Christopher Romero

Soma Clinical Trials

Recruiting

Denison, Texas, United States, 75020

Contacts

Principal Investigator:

Hesham Elgouhari

Epic Medical Research - DeSoto

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Principal Investigator:

HARESH BOGHARA

South Texas Research Institute

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Principal Investigator:

Dimple Desai

Dallas Research Institute

Recruiting

Farmers Branch, Texas, United States, 75234

Contacts

Principal Investigator:

Pedro Castillo

Care United Research, LLC

Recruiting

Forney, Texas, United States, 75126

Contacts

Principal Investigator:

Shilpi Mittal

GI Alliance - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Kumar Gutta

HRI- Medical Center

Recruiting

Houston, Texas, United States, 77004

Principal Investigator:

Joseph Galati

Care Access - Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Principal Investigator:

Ali Bajwa

Houston Research Institute

Recruiting

Houston, Texas, United States, 77079

Contacts

Principal Investigator:

David Huang

Biopharma Informatic, LLC

Recruiting

Houston, Texas, United States, 77084

Contacts

Principal Investigator:

James Arthur Maher Jr., MD

Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Contacts

Principal Investigator:

Amir Hassan

Biopharma Informatic, LLC

Recruiting

McAllen, Texas, United States, 78503

Contacts

Principal Investigator:

Ralph Alhalel, MD

DHR Health Institute for Research and Development (Administrative Office & Laboratory)

Recruiting

McAllen, Texas, United States, 78504

Contacts

Principal Investigator:

Henry Herrera

Southern Endocrinology Associates

Recruiting

Mesquite, Texas, United States, 75149

Contacts

Principal Investigator:

Sumana Gangi

HRI Pasadena

Recruiting

Pasadena, Texas, United States, 77505

Contacts

Principal Investigator:

Rukan Daccak, MD

American Research Corporation at Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Principal Investigator:

Eric Lawitz

Clinical Trials of Texas, LLC dba Flourish Research

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Douglas Denham

IMA Clinical Research San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Lisa Blair

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

Principal Investigator:

Michelle Welch

GI Alliance - Southlake

Recruiting

Southlake, Texas, United States, 76092

Contacts

Principal Investigator:

Timothy Ritter

Houston Research Institute (HRI) - Sugar Land

Recruiting

Sugar Land, Texas, United States, 77479

Principal Investigator:

Sushovan Guha

Texas Valley Clinical Research

Recruiting

Weslaco, Texas, United States, 78596

Contacts

Principal Investigator:

Eduardo Luna

Medrasa Clinical Research

Recruiting

Wylie, Texas, United States, 75098

Contacts

Principal Investigator:

Tanvir Ahmad

Care Access - Ogden

Recruiting

Ogden, Utah, United States, 84403

Contacts

Principal Investigator:

Chad Gonzales

Advanced Research Institute - Sandy

Recruiting

Sandy City, Utah, United States, 84070

Contacts

Principal Investigator:

Robert Barnett

Eximia Research - Norfolk

Recruiting

Norfolk, Virginia, United States, 23502

Principal Investigator:

John Smith

Richmond Veterans Affairs Medical Center (Richmond VA Medical Center)

Recruiting

Richmond, Virginia, United States, 23249

Principal Investigator:

Michael Fuchs

Gastroenterology Consultants of Southwest Virginia

Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator:

Farhad Sahebjam

Washington Gastroenterology - Bellevue

Recruiting

Bellevue, Washington, United States, 98004

Contacts

Principal Investigator:

Nicholas Procaccini

UW Medicine Diabetes Institute

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

Arthi Thirumalai

Washington Gastroenterology - Tacoma

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

Elizabeth Rosenblatt

CAMC Health Education and Research Institute Inc

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Principal Investigator:

Ebubekir Daglilar

Ecogene-21

Recruiting

Chicoutimi, Canada, G7H 7K9

Contacts

Principal Investigator:

Daniel Gaudet

Wells Research Group

Recruiting

Edmonton, Canada, T5L 4G4

Contacts

Principal Investigator:

Malcolm Wells

Private Practice - Dr. Stephane M. Gauthier

Recruiting

North Bay, Canada, P1B 2H3

Contacts

Principal Investigator:

Stephane Gauthier

Diex Recherche Quebec

Recruiting

Québec, Canada, G1V 4T3

Principal Investigator:

Marie-Philippe Morin

Clinical Research of Ontario

Recruiting

Toronto, Canada, M1S 4T7

Contacts

Principal Investigator:

Gerald Chan

Diex Recherche Inc. Division Trois-Rivieres

Recruiting

Trois-Rivières, Canada, G9A 4P3

Principal Investigator:

Jean-francois Naud

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Nonalcoholic Steatohepatitis
  • NASH
  • Fatty Liver
  • Fatty Liver Disease
  • SLD
  • Metabolic Dysfunction-Associated Fatty Liver Disease
  • MAFLD
  • Non-alcoholic Fatty Liver Disease
  • NAFLD
  • Hepatic Steatosis
  • Liver Related Outcomes
  • GLP1
  • Incretin
  • Non-Invasive Test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.