Skip to content
Bored Studies
RecruitingPhase 3

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

Eli Lilly and Company · NCT07165028

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
4500
US sites recruiting
137
Study start
October 15, 2025
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Tirzepatide; Retatrutide; Placebo

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • MFA Clinical Research

    Tuscaloosa, AL 35405

    Site contact: 205-331-4963

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

    Chandler, AZ 85224

    Site contact: Yessica Sachdeva

  • Spectrum Research Institute

    Gilbert, AZ 85297

    Site contact: Donna DeSantis

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

    Peoria, AZ 85381

    Site contact: 480-470-4000

  • Epic Medical Research-Sun City

    Sun City, AZ 85351

    Site contact: Rachel Greatwood

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

    Tucson, AZ 85712

    Site contact: Anita Kohli

  • Del Sol Research Management, LLC

    Tucson, AZ 85715

    Site contact: 520-257-3881

  • Arkansas Gastroenterology - North Little Rock

    North Little Rock, AR 72117

    Site contact: Samuel Dunn

  • San Fernando Valley Health Institute

    Canoga Park, CA 91304

    Site contact: 818-222-6868

  • Ark Clinical Research - Fountain Valley

    Fountain Valley, CA 92708

    Site contact: 714-988-2021

  • Fresno Clinical Research Center

    Fresno, CA 93720

    Site contact: 559-970-3441

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)

    La Jolla, CA 92037

    Site contact: 858-246-2227

  • Orange County Research Center

    Lake Forest, CA 92630

    Site contact: 714-550-9990

  • Om Research LLC

    Lancaster, CA 93534

    Site contact: 661-388-2239

  • Ark Clinical Research

    Long Beach, CA 90815

    Site contact: 562-997-1000

  • Los Angeles Institute for Metabolic Research

    Los Angeles, CA 90015

    Site contact: 213-373-8380

  • United Medical Doctors - Murrieta

    Murrieta, CA 92563

    Site contact: 951-566-5229

  • Knowledge Research Center

    Orange, CA 92868

    Site contact: 657-247-0087

  • California Liver Research Center

    Pasadena, CA 91105

    Site contact: 626-795-5769

  • Artemis Institute for Clinical Research

    Riverside, CA 92503

    Site contact: 951-374-1190

  • Medical Associates Research Group

    San Diego, CA 92123

    Site contact: 858-277-5678

  • Quest Clinical Research

    San Francisco, CA 94115

    Site contact: 415-353-0800

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: 303-724-4651

  • South Denver Gastroenterology

    Englewood, CO 80113

    Site contact: Marcelo Kugelmas

  • Medical Research Center of Connecticut

    Hamden, CT 06518

    Site contact: Paul Feuerstadt

  • K2 Medical Research WINTER GARDEN

    Clermont, FL 34711

    Site contact: 407-426-9299

  • K2 Medical Research - Daytona Beach

    Daytona Beach, FL 32114

    Site contact: Joshua Eisenhut

  • Care Access - Delray Beach

    Delray Beach, FL 33484

    Site contact: 401-773-7855

  • AMR Clinical

    Doral, FL 33172

    Site contact: Abid Chaudhry

  • Southwest General Healthcare Center

    Fort Myers, FL 33907

    Site contact: 239-931-3368

  • University of Florida College of Medicine

    Gainesville, FL 32610

    Site contact: 352-273-8662

  • Encore Medical Research

    Hollywood, FL 33024

    Site contact: 954-400-1725

  • Nature Coast Clinical Research - Inverness

    Inverness, FL 34452

    Site contact: 352-341-2100

  • Encore Borland-Groover Clinical Research

    Jacksonville, FL 32256

    Site contact: 904-680-0871

  • Health Awareness

    Jupiter, FL 33458

    Site contact: Mitchell Davis

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, FL 32159

    Site contact: 352-500-5252

  • Florida Research Institute

    Lakewood Rch, FL 34211

    Site contact: 941-727-7772

  • Tampa Bay Medical Research - Largo

    Largo, FL 33777

    Site contact: 727-724-3316

  • Evolution Clinical Trials

    Miami, FL 33122-1722

    Site contact: 786-706-1216

  • Floridian Clinical Research, LLC

    Miami Lakes, FL 33016-1518

    Site contact: 305-330-9977

  • GI PROS Research

    Naples, FL 34102

    Site contact: 239-571-0899

  • Charter Research - Orlando

    Orlando, FL 32803

    Site contact: Mary Quarterman

  • Headlands Research Orlando

    Orlando, FL 32806

    Site contact: 407-705-3471

  • Progressive Medical Research

    Port Orange, FL 32127

    Site contact: 386-304-7070

  • Covenant Metabolic Specialists - Riverview

    Riverview, FL 33578

    Site contact: 941-894-2014

  • Care Access - St. Petersburg

    St. Petersburg, FL 33710

    Site contact: 877-791-0656

  • Care Access - Tamarac

    Tamarac, FL 33321

    Site contact: 877-791-0656

  • Covenant Metabolic Specialists, LLC

    University Park, FL 34201

    Site contact: 941-894-2014

  • Southeast Clinical Research Center

    Dalton, GA 30720

    Site contact: 706-913-1779

  • Gastrointestinal Specialists of Georgia

    Marietta, GA 30060

    Site contact: 404-786-3100

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, GA 30291

    Site contact: 470-317-3604

  • Indiana University Health University Hospital

    Indianapolis, IN 46202

    Site contact: 317-278-1652

  • Gastroenterology Health Partners

    New Albany, IN 47150

    Site contact: 812-206-1702

  • Deaconess Clinic- Gateway

    Newburgh, IN 47630

    Site contact: 812-490-4505

  • Digestive Research Alliance of Michiana

    South Bend, IN 46635

    Site contact: 574-904-9617

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, IA 50266

    Site contact: Amy Keller

  • AMR Clinical

    El Dorado, KS 67042

    Site contact: 316-600-5127 EXT 301

  • Johnson County Clinical Trials

    Lenexa, KS 66219

    Site contact: Thomas Kreamer

  • Cotton O'Neil Digestive Health Center

    Topeka, KS 66606

    Site contact: 785-368-0477

  • AMR Clinical

    Lexington, KY 40509

    Site contact: Peter Akpunonu

+ 77 more on the official record.

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
All nutrition & metabolism studies in Alabama →
A Master Protocol of Multiple Agents in Adults With Metabolic… (NCT07165028) | Bored Studies