Condition: Metabolic Dysfunction-Associated Steatotic Liver Disease · Sponsor: Eli Lilly and Company
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.
This description comes directly from the study's public registry 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
Always discuss trial participation with your own doctor first.
| MFA Clinical Research | Tuscaloosa, Alabama, United States | Recruiting |
| The Institute for Liver Health II dba Arizona Clinical Trials - Chandler | Chandler, Arizona, United States | Recruiting |
| Spectrum Research Institute | Gilbert, Arizona, United States | Recruiting |
| The Institute for Liver Health II dba Arizona Liver Health - Peoria | Peoria, Arizona, United States | Recruiting |
| Epic Medical Research-Sun City | Sun City, Arizona, United States | Recruiting |
| The Institute for Liver Health II dba Arizona Clinical Trials - Tucson | Tucson, Arizona, United States | Recruiting |
| Del Sol Research Management, LLC | Tucson, Arizona, United States | Recruiting |
| Arkansas Gastroenterology - North Little Rock | North Little Rock, Arkansas, United States | Recruiting |
| San Fernando Valley Health Institute | Canoga Park, California, United States | Recruiting |
| Ark Clinical Research - Fountain Valley | Fountain Valley, California, United States | Recruiting |
| Fresno Clinical Research Center | Fresno, California, United States | Recruiting |
| UCSD - Altman Clinical and Translational Research Institute (ACTRI) | La Jolla, California, United States | Recruiting |
+ 551 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07165028