A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) (NCT07165028)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: MFA Clinical Research — Tuscaloosa, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (565 Sites)
Showing the first 25 of 565 sites.
- MFA Clinical Research — Tuscaloosa, Alabama
- The Institute for Liver Health II dba Arizona Clinical Trials - Chandler — Chandler, Arizona
- Spectrum Research Institute — Gilbert, Arizona
- The Institute for Liver Health II dba Arizona Liver Health - Peoria — Peoria, Arizona
- Epic Medical Research-Sun City — Sun City, Arizona
- The Institute for Liver Health II dba Arizona Clinical Trials - Tucson — Tucson, Arizona
- Del Sol Research Management, LLC — Tucson, Arizona
- Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas
- San Fernando Valley Health Institute — Canoga Park, California
- Ark Clinical Research - Fountain Valley — Fountain Valley, California
- Fresno Clinical Research Center — Fresno, California
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California
- Orange County Research Center — Lake Forest, California
- Om Research LLC — Lancaster, California
- Ark Clinical Research — Long Beach, California
- Los Angeles Institute for Metabolic Research — Los Angeles, California
- United Medical Doctors - Murrieta — Murrieta, California
- Knowledge Research Center — Orange, California
- California Liver Research Center — Pasadena, California
- Artemis Institute for Clinical Research — Riverside, California
- Medical Associates Research Group — San Diego, California
- Quest Clinical Research — San Francisco, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- South Denver Gastroenterology — Englewood, Colorado
- Medical Research Center of Connecticut — Hamden, Connecticut
📞 Contact the Study Coordinator
Phone: (317) 615-4559
Email: LillyTrials@Lilly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metabolic Dysfunction-Associated Steatotic Liver Disease
- How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver — Sherbrooke, Quebec
- Ultrasound Liver Imaging for Classification of Metabolic Dysfunction-associated Steatotic Liver Disease — Vancouver, British Columbia
- Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD — Boardman, Ohio
- A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) — Chandler, Arizona
- Advanced Fibrosis Detection for MASLD in Primary Care — Charleston, South Carolina
Explore by condition: All Metabolic Dysfunction-Associated Steatotic Liver Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.