A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT07165028
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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.
Interventions
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Tirzepatide
(Drug)
Administered SC
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Retatrutide
(Drug)
Administered SC
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Placebo
(Drug)
Administered SC
Eligibility criteria
Conditions
Locations
- MFA Clinical Research — Tuscaloosa, Alabama, United States
- The Institute for Liver Health II dba Arizona Clinical Trials - Chandler — Chandler, Arizona, United States
- Spectrum Research Institute — Gilbert, Arizona, United States
- The Institute for Liver Health II dba Arizona Liver Health - Peoria — Peoria, Arizona, United States
- Epic Medical Research-Sun City — Sun City, Arizona, United States
- The Institute for Liver Health II dba Arizona Clinical Trials - Tucson — Tucson, Arizona, United States
- Del Sol Research Management, LLC — Tucson, Arizona, United States
- Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas, United States
- San Fernando Valley Health Institute — Canoga Park, California, United States
- Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States
- Fresno Clinical Research Center — Fresno, California, United States
- UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
- Orange County Research Center — Lake Forest, California, United States
- Om Research LLC — Lancaster, California, United States
- Ark Clinical Research — Long Beach, California, United States
- Los Angeles Institute for Metabolic Research — Los Angeles, California, United States
- United Medical Doctors - Murrieta — Murrieta, California, United States
- Knowledge Research Center — Orange, California, United States
- California Liver Research Center — Pasadena, California, United States
- Artemis Institute for Clinical Research — Riverside, California, United States
- Medical Associates Research Group — San Diego, California, United States
- Quest Clinical Research — San Francisco, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- South Denver Gastroenterology — Englewood, Colorado, United States
- Medical Research Center of Connecticut — Hamden, Connecticut, United States
- K2 Medical Research WINTER GARDEN — Clermont, Florida, United States
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- University of Florida College of Medicine — Gainesville, Florida, United States
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- The Cognitive and Research Center of New Jersey - Ridgewood — Ridgewood, New Jersey, United States
- IMA Clinical Research Warren — Warren Township, New Jersey, United States
- Southwest Gastroenterology Associates — Albuquerque, New Mexico, United States
- Research Foundation of SUNY - University of Buffalo — Buffalo, New York, United States
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- Carteret Medical Group — Morehead City, North Carolina, United States
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- Dayton Gastroenterology - Beavercreek — Beavercreek, Ohio, United States
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- US Digestive Health - Flourtown — Flourtown, Pennsylvania, United States
- Penn Medicine: University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
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- Galen Medical Group - Galen Hepatology — Chattanooga, Tennessee, United States
- Gastro One (Walnut Run Road) — Cordova, Tennessee, United States
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- Soma Clinical Trials — Denison, Texas, United States
- Epic Medical Research - DeSoto — DeSoto, Texas, United States
- South Texas Research Institute — Edinburg, Texas, United States
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- American Research Corporation at Texas Liver Institute — San Antonio, Texas, United States
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- Radboudumc — Nijmegen, Netherlands
- Erasmus Medisch Centrum — Rotterdam, Netherlands
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
- Progress Clinical Research - Zwolle — Zwolle, Netherlands
- New Zealand Clinical Research (Auckland) — Auckland, New Zealand
- Aotearoa Clinical Trials — Auckland, New Zealand
- Aotearoa Clinical Trials - Whangarei — Whangarei, New Zealand
- Oslo Universitetssykehus Ullevål — Oslo, Norway
- Universitetssykehuset Nord-Norge HF — Tromsø, Norway
- KRESMED Sp. z o.o. — Bialystok, Poland
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, Poland
- Centrum Medyczne Pratia Katowice — Katowice, Poland
- Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero — Katowice, Poland
- Santa Familia PTG Lodz — Lodz, Poland
- ID Clinic — Mysłowice, Poland
- Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej — Poznan, Poland
- Private Practice - Dr. Lukasz Krupa — Rzeszów, Poland
- NZOZ GynCentrum - Oddział Warszawa — Warsaw, Poland
- Przychodnie Care Access — Warsaw, Poland
- Szpital Czerniakowski — Warsaw, Poland
- MTZ Clinical Research Powered by Pratia — Warsaw, Poland
- Państwowy Instytut Medyczny MSWiA — Warsaw, Poland
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Poland
- ETG Zamość — Zamość, Poland
- Associação Protectora dos Diabéticos de Portugal — Lisbon, Portugal
- Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria — Lisbon, Portugal
- Isis Clinical Research Center — Guaynabo, Puerto Rico
- Klinical Investigations Group — San Juan, Puerto Rico
- Delta Health Care — Bucharest, Romania
- Spitalul Clinic Colentina — Bucharest, Romania
- Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor — Cluj-Napoca, Romania
- Constanta County Emergency Clinical Hospital Sf.Ap.Andrei — Constanța, Romania
- Spital Judetean de Urgenta — Satu Mare, Romania
- Korea University Ansan Hospital — Ansan-si, South Korea
- Soon Chun Hyang University Bucheon Hospital — Bucheon-si, South Korea
- Pusan National University Yangsan Hospital — Busan, South Korea
- Yeungnam Univeristy Medical Center — Daegu, South Korea
- Keimyung University Dongsan Hospital — Daegu, South Korea
- Chung-Ang University Hospital — Dongjak-gu, South Korea
- Boramae Medical Center — Dongjak-gu, South Korea
- Hanyang University Guri Hospital — Guri-si, South Korea
- Inha University Hospital — Incheon, South Korea
- Gyeongsang National University Hospital — Jinju, South Korea
- Kyungpook National University Hospital — Junggu, South Korea
- Seoul National University Hospital — Seoul, South Korea
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Hanyang University Seoul Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, South Korea
- Wonju Severance Christian Hospital — Wŏnju, South Korea
- CHUAC-Complejo Hospitalario Universitario A Coruña — A Coruña, Spain
- Hospital Germans Trias i Pujol — Badalona, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval — Ferrol, Spain
- Hospital Infanta Elena — Huelva, Spain
- Hospital General Universitario Gregorio Marañon — Madrid, Spain
- Hospital Universitario La Paz — Madrid, Spain
- Hospital Universitari Son Espases — Palma, Spain
- CHOP - Hospital Universitario Montecelo — Pontevedra, Spain
- Hospital Universitario Marqués de Valdecilla — Santander, Spain
- Hospital Universitario Virgen Del Rocio — Seville, Spain
- Hospital Clinico de Valencia — Valencia, Spain
- Hospital Universitari i Politecnic La Fe — Valencia, Spain
- Universitetssjukhuset i Linköping — Linköping, Sweden
- University Hospital Basel — Basel, Switzerland
- Kantonsspital Olten — Olten, Switzerland
- Chiayi Christian Hospital — Chiayi City, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
- E-Da hospital — Kaohsiung City, Taiwan
- Chang Gung Memorial Hospital at Kaohsiung — Kaohsiung Niao Sung Dist, Taiwan
- Taipei Tzu Chi General Hospital — New Taipei City, Taiwan
- Fu Jen Catholic University Hospital — New Taipei City, Taiwan
- China Medical University Hospital — Taichung, Taiwan
- Taichung Veterans General Hospital — Taichung, Taiwan
- National Cheng Kung University Hospital — Tainan, Taiwan
- Chi Mei Medical Center — Tainan, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
- Cathay General Hospital — Taipei, Taiwan
- Taipei Medical University Hospital — Taipei, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
- Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
- Adana Sehir Egitim ve Arastirma Hastanesi — Adana, Turkey (Türkiye)
- Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi — Adana, Turkey (Türkiye)
- Hacettepe Universitesi — Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi — Ankara, Turkey (Türkiye)
- Bursa Şehir Hastanesi — Bursa, Turkey (Türkiye)
- T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi — Pendik, Turkey (Türkiye)
- Recep Tayyip Erdogan University Training and Research Hospital — Rize, Turkey (Türkiye)
- Karadeniz Teknik Universitesi Tip Fakultesi — Trabzon, Turkey (Türkiye)
- Clinical Diagnostic Center — Ivano-Frankivsk, Ukraine
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical" — Kiev, Ukraine
- Edelweiss Medics — Kyiv, Ukraine
- Medical Center Ok!Clinic+ — Kyiv, Ukraine
- Medbud Clinic — Kyiv, Ukraine
- Center of Family Medicine Plus — Kyiv, Ukraine
- Progastro Clinic — Lviv, Ukraine
- Medical Center Salutem — Vinnytsia, Ukraine
- Limited liability company "Medical center Health Clinic" — Vinnytsia, Ukraine
- Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T — Vinnytsia, Ukraine
- CRZ Vidnovlennya — Zhytomyr, Ukraine
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom
- 4 Medical Solutions, Ltd - Manchester — Clifton, United Kingdom
- Panthera Biopartners - North London — Enfield, United Kingdom
- Panthera Biopartners - Glasgow — Glasgow, United Kingdom
- Ipswich Hospital — Ipswich, United Kingdom
- Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom
- Royal London Hospital — London, United Kingdom
- 4 Medical Solutions, Ltd - London — London, United Kingdom
- Royal Free Hospital — London, United Kingdom
- King's College Hospital — London, United Kingdom
- Freeman Hospital — Newcastle upon Tyne, United Kingdom
- The John Radcliffe Hospital — Oxford, United Kingdom
- Atlantic Medical — Penzance, United Kingdom
- Panthera Biopartners - Preston — Preston, United Kingdom
- Panthera Biopartners - Manchester — Rochdale, United Kingdom
- Panthera Biopartners - Sheffield — Sheffield, United Kingdom
- Panthera Clinic - York — York, United Kingdom
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