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A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
NCT07165028 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Tirzepatide
- DRUG Retatrutide
Study Locations (20)
California
- San Fernando Valley Health Institute — Canoga Park
- Ark Clinical Research - Fountain Valley — Fountain Valley
- Fresno Clinical Research Center — Fresno
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla
- Orange County Research Center — Lake Forest
- Om Research LLC — Lancaster
- Ark Clinical Research — Long Beach
- Los Angeles Institute for Metabolic Research — Los Angeles
- United Medical Doctors - Murrieta — Murrieta
- Knowledge Research Center — Orange
- California Liver Research Center — Pasadena
- Artemis Institute for Clinical Research — Riverside
Arizona
- The Institute for Liver Health II dba Arizona Clinical Trials - Chandler — Chandler
- Spectrum Research Institute — Gilbert
- The Institute for Liver Health II dba Arizona Liver Health - Peoria — Peoria
- Epic Medical Research-Sun City — Sun City
- The Institute for Liver Health II dba Arizona Clinical Trials - Tucson — Tucson
- Del Sol Research Management, LLC — Tucson
Alabama
- MFA Clinical Research — Tuscaloosa
Arkansas
- Arkansas Gastroenterology - North Little Rock — North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,500 participants |
| Start Date | 2025-10-15 |
| Est. Completion | 2032-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07165028
The ClinicalTrials.gov registry entry for NCT07165028 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metabolic Dysfunction-Associated Steatotic Liver Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07165028 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07165028 about?
NCT07165028 is a clinical study titled "A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)". 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-invasi...
What is the current status of trial NCT07165028?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,500 participants. The study started on 2025-10-15. Estimated completion is 2032-08.
What conditions does trial NCT07165028 study?
This clinical trial studies the following conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07165028?
The interventions under investigation include: Placebo (DRUG), Tirzepatide (DRUG), Retatrutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07165028?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07165028 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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