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
- Amagasaki, Asahikawa, Bunkyō, Bunkyō City, Chikushino-shi, Fukuoka, Gifu, Ginowan, Hamamatsu, Hiroshima, Ichikawa, Izumo, Izunokuni, Kagoshima, Kashihara, Kawasaki, Kita-ku, Kofu, Kumamoto, Kurume, Kyoto, Maebashi, Minatoku, Musashino-shi, Nagasaki, Nagoya, Narita, Nishinomiya, Ōgaki, Ōita, Okayama, Ōmura, Osaka, Saga, Sakai, Sapporo, Shimotsuke, Shinjuku-ku, Shinjyuku-ku, Shiwa-gun Yahaba-cho, Suita, tabashi City, Takamatsu, Takasaki, Tokyo, Tomitake, Tōon, Toshimaku, Tsu, Ureshino, Yamagata, and Yokohama, JapanSee the 65 sites
- Phase
- Phase 3
Where in Japan
- Hyogo Prefectural Amagasaki General Medical CenterAmagasaki, JapanTaking people
- Kansai Rosai HospitalAmagasaki, JapanTaking people
- Asahikawa Medical University HospitalAsahikawa, JapanTaking people
- Institute of Science Tokyo HospitalBunkyō, JapanTaking people
- Juntendo University HospitalBunkyō City, JapanTaking people
- The University of Tokyo HospitalBunkyō City, JapanTaking people
- Tokyo Metropolitan Komagome HospitalBunkyō City, JapanTaking people
- Fukuoka University Chikushi HospitalChikushino-shi, JapanTaking people
- Fukuoka University HospitalFukuoka, JapanTaking people
- Hamanomachi HospitalFukuoka, JapanTaking people
- Gifu Municipal HospitalGifu, JapanTaking people
- University of the Ryukyus HospitalGinowan, JapanTaking people
- Hamamatsu University HospitalHamamatsu, JapanTaking people
- Hiroshima University HospitalHiroshima, JapanTaking people
- National Kohnodai Medical Center.Ichikawa, JapanTaking people
- Shimane University HospitalIzumo, JapanTaking people
- Juntendo University Shizuoka HospitalIzunokuni, JapanTaking people
- Kagoshima University HospitalKagoshima, JapanTaking people
- Nara Medical University HospitalKashihara, JapanTaking people
- St. Marianna University HospitalKawasaki, JapanTaking people
- Kagawa University HospitalKita-ku, JapanTaking people
- Yamanashi Prefectural Central HospitalKofu, JapanTaking people
- Kumamoto Shinto General HospitalKumamoto, JapanTaking people
- Kumamoto University HospitalKumamoto, JapanTaking people
- Kurume University HospitalKurume, JapanTaking people
- University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Saiseikai Maebashi HospitalMaebashi, JapanTaking people
- Tokyo Saiseikai Central HospitalMinatoku, JapanTaking people
- Toranomon HospitalMinatoku, JapanTaking people
- Japanese Red Cross Musashino HospitalMusashino-shi, JapanTaking people
- Nagasaki University HospitalNagasaki, JapanTaking people
- Meitetsu HospitalNagoya, JapanTaking people
- Nagoya City University HospitalNagoya, JapanTaking people
- International University of Health and Welfare Narita HospitalNarita, JapanTaking people
- Hyogo Medical University HospitalNishinomiya, JapanTaking people
- Ogaki Municipal HospitalŌgaki, JapanTaking people
- Abe ClinicŌita, JapanTaking people
- Oita Cardiovascular HospitalŌita, JapanTaking people
- Okayama University HospitalOkayama, JapanTaking people
- National Hospital Organization Nagasaki Medical CenterŌmura, JapanTaking people
- National Hospital Organization Osaka National HospitalOsaka, JapanTaking people
- Osaka General Medical CenterOsaka, JapanTaking people
- Osaka Keisatsu HospitalOsaka, JapanTaking people
- Osaka Metropolitan University HospitalOsaka, JapanTaking people
- Saga University HospitalSaga, JapanTaking people
- Bell Land General HospitalSakai, JapanTaking people
- Osaka Rosai HospitalSakai, JapanTaking people
- Hokkaido University HospitalSapporo, JapanTaking people
- Jichi Medical University HospitalShimotsuke, JapanTaking people
- Tokyo Medical University HospitalShinjuku-ku, JapanTaking people
- National Center for Global Health and MedicineShinjyuku-ku, JapanTaking people
- Iwate Medical University HospitalShiwa-gun Yahaba-cho, JapanTaking people
- Osaka Saiseikai Suita hospitalSuita, JapanTaking people
- The University of Osaka HospitalSuita, JapanTaking people
- Nihon University Itabashi Hospitaltabashi City, JapanTaking people
- Kagawa Prefectural Central HospitalTakamatsu, JapanTaking people
- National Hospital Organization Takasaki General Medical CenterTakasaki, JapanTaking people
- Tokyo Women's Medical UniversityTokyo, JapanTaking people
- Nagano Municipal HospitalTomitake, JapanTaking people
- Ehime University HospitalTōon, JapanTaking people
- Sekino HospitalToshimaku, JapanTaking people
- Mie University HospitalTsu, JapanTaking people
- National Hospital Organization Ureshino Medical CenterUreshino, JapanTaking people
- Yamagata University HospitalYamagata, JapanTaking people
- Yokohama City University HospitalYokohama, JapanTaking 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).