Tests retatrutide and tirzepatide in adults with fatty liver disease at high risk
Tests retatrutide and tirzepatide in adults with fatty liver disease to prevent serious liver problems.
Plain-language title generated from the registry record
Registry title: A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Foshan, Fuzhou, Guangzhou, Guiyang, Hangzhou, Jinhua, Liaocheng, Luoyang, Luzhou, Nanchang, Nanjing, Nanyang, Ningbo, Pingxiang, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Tianjin, Wenzhou, Xi’an, Yinchuan, and Zhoukou, ChinaSee the 40 sites
- Phase
- Phase 3
Where in China
- Beijing Ditan HospitalBeijing, ChinaTaking people
- Beijing Friendship Hospital Affiliate of Capital UniversityBeijing, ChinaTaking people
- Beijing YouAn HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Hunan Provincial People's HospitalChangsha, ChinaTaking people
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- 2nd Affiliated Hospital Chongqing Medical UniversiChongqing, ChinaTaking people
- The First People's Hospital of FoshanFoshan, ChinaTaking people
- Fujian Medical University Mengchao Hepatobiliary Hospital (Fuzhou Infectious Disease Hospital)Fuzhou, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- Guangzhou 8th People's HospitalGuangzhou, ChinaTaking people
- Southern Medical University Nanfang HospitalGuangzhou, ChinaTaking people
- Guizhou Provincial People's HospitalGuiyang, ChinaTaking people
- The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaTaking people
- Affiliated Hospital of Hangzhou Normal UniversityHangzhou, ChinaTaking people
- Jinhua Central HospitalJinhua, ChinaTaking people
- Liaocheng People's HospitalLiaocheng, ChinaTaking people
- The First Affiliated Hospital of Henan University of Science &TechnologyLuoyang, ChinaTaking people
- The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaTaking people
- The First affiliated hospital of Nanchang University (Xianghu campus)Nanchang, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- The First Affiliated Hospital of Nanyang Medical CollegeNanyang, ChinaTaking people
- Ningbo 2nd HospitalNingbo, ChinaTaking people
- Ningbo Medical CenterNingbo, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Pingxiang People's HospitalPingxiang, ChinaTaking people
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
- Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaTaking people
- Peking University Shenzhen HospitalShenzhen, ChinaTaking people
- The Third Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Tianjin People's HospitalTianjin, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaTaking people
- General Hospital of Ningxia Medical UniversityYinchuan, ChinaTaking people
- Zhoukou Central HospitalZhoukou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07165028EU 2025-522674-36-00
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 any other type of liver disease other than MASLD; Have type 1 diabetes; Have a hemoglobin A1c (HbA1c) greater than 10%; Have a body mass index (BMI) <25 kilogram per square meter (kg/m2).