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
Brief summary:
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
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
4500 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Tirzepatide (TZ01)
placebo comparator: Placebo (TZ01)
experimental: Retatrutide (RT01)
placebo comparator: Placebo (RT01)
Interventions
Tirzepatide
Retatrutide
Placebo
Primary outcome measure
Central contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559LillyTrials@Lilly.comPhysicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.comLocations
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
Sponsor
Eli Lilly and Company
Last update posted
Aug 21, 2026
Last verified
Aug, 2026
Keywords
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.