A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
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
5 other identifiers
interventional
4,500
34 countries
546
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
Longer than P75 for phase_3
546 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2032
April 17, 2026
April 1, 2026
4.8 years
August 28, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality
Baseline up to Study Completion (about 224 weeks)
Secondary Outcomes (9)
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Baseline, Week 104
Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)
Baseline, Week 104
Percent Change from Baseline in Liver Fat Content (LFC)
Baseline, Week 104
Time to Occurrence of Progression to Cirrhosis
Baseline up to Study Completion (about 224 weeks)
Change from Baseline in Aspartate Aminotransferase (AST)
Baseline, Study Completion (about 224 weeks)
- +4 more secondary outcomes
Study Arms (4)
Tirzepatide (TZ01)
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC)
Placebo (TZ01)
PLACEBO COMPARATORParticipants will receive placebo SC
Retatrutide (RT01)
EXPERIMENTALParticipants will receive retatrutide SC
Placebo (RT01)
PLACEBO COMPARATORParticipants will receive placebo SC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have any other type of liver disease other than MASLD
- Have a body mass index (BMI) \<25 kilogram per square meter (kg/m2)
- 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 a hemoglobin A1c (HbA1c) greater than 10%
- Have type 1 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (561)
MFA Clinical Research
Tuscaloosa, Alabama, 35405, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
Chandler, Arizona, 85224, United States
Spectrum Research Institute
Gilbert, Arizona, 85297, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria
Peoria, Arizona, 85381, United States
Epic Medical Research-Sun City
Sun City, Arizona, 85351, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Tucson
Tucson, Arizona, 85712, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, 72117, United States
San Fernando Valley Health Institute
Canoga Park, California, 91304, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Om Research LLC
Lancaster, California, 93534, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015, United States
United Medical Doctors - Murrieta
Murrieta, California, 92563, United States
Knowledge Research Center
Orange, California, 92868, United States
California Liver Research Center
Pasadena, California, 91105, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
K2 Medical Research WINTER GARDEN
Clermont, Florida, 34711, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, 32114, United States
Care Access - Delray Beach
Delray Beach, Florida, 33484, United States
AMR Clinical
Doral, Florida, 33172, United States
Southwest General Healthcare Center
Fort Myers, Florida, 33907, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida, 34452, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256, United States
Health Awareness
Jupiter, Florida, 33458, United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida, 32159, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Tampa Bay Medical Research - Largo
Largo, Florida, 33777, United States
Evolution Clinical Trials
Miami, Florida, 33122-1722, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016-1518, United States
GI PROS Research
Naples, Florida, 34102, United States
Charter Research - Orlando
Orlando, Florida, 32803, United States
Headlands Research Orlando
Orlando, Florida, 32806, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Covenant Metabolic Specialists - Riverview
Riverview, Florida, 33578, United States
Care Access - St. Petersburg
St. Petersburg, Florida, 33710, United States
Care Access - Tamarac
Tamarac, Florida, 33321, United States
Covenant Metabolic Specialists, LLC
University Park, Florida, 34201, United States
Southeast Clinical Research Center
Dalton, Georgia, 30720, United States
Teak Research Consults
Lawrenceville, Georgia, 30043, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology Health Partners
New Albany, Indiana, 47150, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, 47630, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, 46635, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
AMR Clinical
El Dorado, Kansas, 67042, United States
Johnson County Clinical Trials
Lenexa, Kansas, 66219, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
AMR Clinical
Lexington, Kentucky, 40509, United States
Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana, 71220, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Care Access - New Iberia
New Iberia, Louisiana, 70560, United States
Louisiana Research Center
Shreveport, Louisiana, 71105, United States
Delta Research Partners of West Monroe
West Monroe, Louisiana, 71291, United States
Mercy Medical Center - Baltimore
Baltimore, Maryland, 21202, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, 20815, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, 48038, United States
Great Lakes Research Institute
Southfield, Michigan, 48075, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
MNGI Digestive Health
Minneapolis, Minnesota, 55413, United States
GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi, 39232, United States
AMR Clinical
Kansas City, Missouri, 64114, United States
Jubilee Clinical Research NV. LLC
Las Vegas, Nevada, 89106, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109, United States
Advanced Research Institute - Reno
Reno, Nevada, 89511, United States
Tandem Clinical Research - Freehold
Freehold, New Jersey, 07728, United States
Atlantic Health System Morristown Medical Center
Morristown, New Jersey, 07960, United States
Clinical Research of Philadelphia
Pennington, New Jersey, 08534, United States
The Cognitive and Research Center of New Jersey - Ridgewood
Ridgewood, New Jersey, 07450, United States
IMA Clinical Research Warren
Warren Township, New Jersey, 07059, United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109, United States
Research Foundation of SUNY - University of Buffalo
Buffalo, New York, 14203, United States
NYU Langone Health
New York, New York, 10016, United States
IMA Clinical Research Manhattan
New York, New York, 10036, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
Care Access - Yonkers
Yonkers, New York, 10701, United States
Duke University - Main Hospital and Clinics
Durham, North Carolina, 27710, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Akron Gastro Research
Akron, Ohio, 44320, United States
Dayton Gastroenterology - Beavercreek
Beavercreek, Ohio, 45440, United States
CRIOH
Westlake, Ohio, 44145, United States
US Digestive Health - Flourtown
Flourtown, Pennsylvania, 19031, United States
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
US Digestive Health - Wyomissing
Wyomissing, Pennsylvania, 19610, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Columbia Digestive Health Research
Columbia, South Carolina, 29204, United States
Galen Medical Group - Galen Hepatology
Chattanooga, Tennessee, 37421, United States
Gastro One (Walnut Run Road)
Cordova, Tennessee, 38018, United States
American Research Corporation at Texas Liver Institute
Austin, Texas, 78215, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
American Research Corporation
Austin, Texas, 78757, United States
Pinnacle Clinical Research
Austin, Texas, 78757, United States
Bellaire Clinical Research
Bellaire, Texas, 77401, United States
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520, United States
Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas, 78526, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
South Texas Research Institute
Edinburg, Texas, 78539, United States
Dallas Research Institute
Farmers Branch, Texas, 75234, United States
Care United Research, LLC
Forney, Texas, 75126, United States
GI Alliance - Fort Worth
Fort Worth, Texas, 76104, United States
HRI- Medical Center
Houston, Texas, 77004, United States
Care Access - Houston
Houston, Texas, 77054, United States
Houston Research Institute
Houston, Texas, 77079, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Research Physicians Network, LLC
Houston, Texas, 77089, United States
Biopharma Informatic, LLC
McAllen, Texas, 78503, United States
DHR Health Institute for Research and Development (Administrative Office & Laboratory)
McAllen, Texas, 78504, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
HRI Pasadena
Pasadena, Texas, 77505, United States
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
GI Alliance - Southlake
Southlake, Texas, 76092, United States
Houston Research Institute (HRI) - Sugar Land
Sugar Land, Texas, 77479, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Medrasa Clinical Research
Wylie, Texas, 75098, United States
Care Access - Ogden
Ogden, Utah, 84403, United States
Advanced Research Institute - Sandy
Sandy City, Utah, 84070, United States
Eximia Research - Norfolk
Norfolk, Virginia, 23502, United States
Richmond Veterans Affairs Medical Center (Richmond VA Medical Center)
Richmond, Virginia, 23249, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 24014, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98004, United States
UW Medicine Diabetes Institute
Seattle, Washington, 98109, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405, United States
CAMC Health Education and Research Institute Inc
Charleston, West Virginia, 25304, United States
Hospital Italiano de Buenos Aires
ABB, C1199ABB, Argentina
CIPREC
Buenos Aires, 1061, Argentina
DOM Centro de Reumatología
Buenos Aires, 1111, Argentina
Cicemo Srl
Buenos Aires, 1424, Argentina
Glenny Corp. S.A.
Buenos Aires, 1430, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, B7600FZO, Argentina
DIM Clínica Privada
Ramos Mejía, B1704ETD, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario, S2000CVD, Argentina
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, 3000, Argentina
Nightingale Research
Adelaide, 5000, Australia
Flinders Medical Centre
Adelaide, 5042, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Royal Brisbane and Women's Hospital
Brisbane, 4029, Australia
Core Research Group
Brisbane, 4064, Australia
Mater Misericordiae Limited
Brisbane, 4101, Australia
Gallipoli Medical Research Ltd
Brisbane, 4120, Australia
Genesis Research Services
Broadmeadow, 2292, Australia
Austin Health
Heidelberg, 3084, Australia
Ipswich Hospital
Ipswich, 4305, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
TrialsWest - Osborne Park
Osborne Park, 6017, Australia
The Royal Melbourne Hospital
Parkville, 3050, Australia
Gold Coast University Hospital
Southport, 4215, Australia
Westmead Hospital
Westmead, 2145, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Uniklinikum Salzburg
Salzburg, 5020, Austria
Klinik Landstraße
Vienna, 1030, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700, Austria
Centre Hospitalier Universitaire Brugmann
Brussels, 1020, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Antwerp University Hospital
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500, Belgium
AZ Oostende vzw
Ostend, 8400, Belgium
AZ Delta vzw
Roeselare, 8800, Belgium
VITAZ
Sint-Niklaas, B-9100, Belgium
NewData Clinical Research - Aracaju
Aracaju, 49075-000, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, 14784400, Brazil
Hospital Universitário João de Barros Barreto
Belém, 66073-000, Brazil
NUPEC - Cardio
Belo Horizonte, 30220-140, Brazil
Faculdade de Medicina da UNESP
Botucatu, 18618-686, Brazil
Centro de Pesquisa Clinica do Brasil
Brasília, 71625-175, Brazil
Chronos Pesquisa Clínica
Brasília, 72145-450, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, 13060-080, Brazil
Cline Research Center
Curitiba, 80030-480, Brazil
Hospital Universitario Walter Cantidio
Fortaleza, 60430-270, Brazil
Universidade Federal de Goias
Goiânia, 74605-020, Brazil
Hospital Brasilia
Lago Sul, 71635580, Brazil
CHN - Complexo Hospitalar de Niterói
Niterói, 24020-096, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Hospital Moinhos de Vento
Porto Alegre, 90560032, Brazil
IMV Pesquisa Cardiologica - Porto Alegre - Rua Orfanotrofio
Porto Alegre, 90840-440, Brazil
Instituto do Fígado e Tranplantes de Pernambuco
Recife, 50100-130, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180, Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro, 21941-913, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060, Brazil
Inovace Pesquisa Clínica
Salvador, 41820-000, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, 09715-090, Brazil
CPHosp Medicina, Ensino e Pesquisa (CPQuali)
São Paulo, 01228-000, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
Hospital das Clinicas FMUSP
São Paulo, 05403-000, Brazil
CEDOES
Vitória, 29055450, Brazil
University Hospital "St. Ivan Rilski"
Gorna Oryahovitsa, 5100, Bulgaria
Saint Marina Hospital
Pleven, 5800, Bulgaria
UMHATEM 'N.I. Pirogov'
Sofia, 1606, Bulgaria
Heritage Medical Research Clinic
Calgary, T2N 4Z6, Canada
Ecogene-21
Chicoutimi, G7H 7K9, Canada
Wells Research Group
Edmonton, T5L 4G4, Canada
University Of Alberta Hospital
Edmonton, T6G 2C8, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, B3H 2Y9, Canada
University Hospital - London Health Sciences Centre
London, N6A 5A5, Canada
Private Practice - Dr. Stephane M. Gauthier
North Bay, P1B 2H3, Canada
Diex Recherche Quebec
Québec, G1V 4T3, Canada
Clinical Research of Ontario
Toronto, M1S 4T7, Canada
Toronto General Hospital
Toronto, M5G 2C4, Canada
St. Joseph's Health Centre
Toronto, M6R 1B5, Canada
Diex Recherche Inc. Division Trois-Rivieres
Trois-Rivières, G9A 4P3, Canada
Vancouver General Hospital
Vancouver, V5Z 1M9, Canada
(G.I.R.I.) GI Research Institute Foundation
Vancouver, V5Z 2K5, Canada
Health Sciences Centre Winnipeg
Winnipeg, R3A 1R9, Canada
Beijing Ditan Hospital
Beijing, 100015, China
Peking University People's Hospital
Beijing, 100034, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, 100050, China
Beijing Youan Hospital
Beijing, 100069, China
Hunan Provincial People's Hospital
Changsha, 410005, China
Xiangya Hospital Central South University
Changsha, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
2nd Affiliated Hospital Chongqing Medical University
Chongqing, 400010, China
The First People's Hospital of Foshan
Foshan, 528041, China
Fujian Medical University Mengchao Hepatobiliary Hospital (Fuzhou Infectious Disease Hospital)
Fuzhou, 350025, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350207, China
Guangzhou 8th People's Hospital
Guangzhou, 510060, China
Southern Medical University Nanfang Hospital
Guangzhou, 510515, China
Guizhou Provincial People's Hospital
Guiyang, 550002, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004, China
Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310015, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310016, China
Jinhua Central Hospital
Jinhua, 321000, China
Liaocheng People's Hospital
Liaocheng, 252000, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471003, China
The Affiliated Hospital of Southwest Medical University
Luzhou, 646000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, 330209, China
Jiangsu Province Hospital
Nanjing, 210029, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
Ningbo 2nd Hospital
Ningbo, 315000, China
The first affiliated hospital of Ningbo university
Ningbo, 315010, China
Ningbo Medical Center
Ningbo, 315041, China
Pingxiang People's Hospital
Pingxiang, 337055, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Zhongshan Hospital,Fudan University
Shanghai, 200032, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200092, China
Shengjing Hospital of China Medical University
Shenyang, 110022, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
The Third Hospital of Hebei Medical University
Shijiazhuang, 050051, China
Tianjin People' s Hospital
Tianjin, 300121, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Union Hospital
Wuhan, 430022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
General Hospital of Ningxia Medical University
Yinchuan, 750004, China
Zhoukou Central Hospital
Zhoukou, 466000, China
Krajská nemocnice Liberec
Liberec, 460 01, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Mestska nemocnice Ostrava
Ostrava, 728 80, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, 80054, France
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
CHU Besançon
Besançon, 25000, France
Hôpital Beaujon
Clichy, 92110, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21079, France
CHD Vendee
La Roche-sur-Yon, 85000, France
Hopital Claude Huriez - CHU de Lille
Lille, 59037, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06200, France
Pitie Salpetriere University Hospital
Paris, 75013, France
Hôpital Saint Antoine
Paris, 75571, France
CHU Bordeaux Haut-Leveque
Pessac, 33600, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69494 Cédex, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35000, France
CHU Rangueil
Toulouse, 31059, France
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux, 69200, France
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Städtisches Klinikum Brandenburg
Brandenburg, 14770, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, 01307, Germany
Deutsches Diabetes-Zentrum (DDZ)
Düsseldorf, 40225, Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, 60590, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum des Saarlandes
Homburg, 66424, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131, Germany
Ruppiner Kliniken
Neuruppin, 16816, Germany
Queen Mary Hospital
Hksar, Hong Kong
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, 4400, Hungary
Avron Hospitals
Ahmedabad, 380013, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012, India
Amrita Institute of Medical Sciences and Research Center
Ernākulam, 682041, India
Asian Institute of Gastroenterology
Hyderabad, 500032, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, 302006, India
Lisie Hospital
Kochi, 682018, India
John C. Martin Centre for Liver Research & Innovations (JCMLRI)
Kolkata, 700150, India
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, 226014, India
Dayanand Medical College and Hospital
Ludhiana, 141001, India
Fortis Hospital - Mohali
Mohali, 160062, India
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, 400008, India
Mysore Medical College
Mysore, 570001, India
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur, 440010, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
Nagpur, 441108, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
All India Institute of Medical Sciences - Rishikesh
Rishikesh, 249203, India
Surat Institute of Digestive Sciences Hospitals
Surat, 395002, India
Acharya Vinoba Bhave Rural Hospital
Wardha, 442004, India
Barzilai Medical Center
Ashkelon, 7830604, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Hospital
Haifa, 3436212, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Shaare Zedek Medical Center
Jerusalem, 9778419, Israel
Maccabi Health Services - Petah Tikva
Petah Tikva, 4925110, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky Medical Center
Tel Aviv, 6423906, Israel
Assuta Medical Center
Tel Aviv, 6971014, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, 80131, Italy
Azienda Ospedale - Università Padova
Padova, 35128, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, 00128, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Kansai Rosai Hospital
Amagasaki, 660-8511, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, 660-8550, Japan
Asahikawa Medical University Hospital
Asahikawa, 078-8510, Japan
Institute of Science Tokyo Hospital
Bunkyō, 113-8519, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
The University of Tokyo Hospital
Bunkyō City, 113-8654, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-0067, Japan
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Gifu Municipal Hospital
Gifu, 500-8513, Japan
University of the Ryukyus Hospital
Ginowan, 901-2725, Japan
Hamamatsu University Hospital
Hamamatsu, 431-3192, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
National Kohnodai Medical Center
Ichikawa, 272-8516, Japan
Nihon University Itabashi Hospital
Itabashiku, 173-8610, Japan
Shimane University Hospital
Izumo, 693-8501, Japan
Juntendo University Shizuoka Hospital
Izunokuni, 410-2211, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Nara Medical University Hospital
Kashihara, 634-0813, Japan
St. Marianna University Hospital
Kawasaki, 216-8511, Japan
Kagawa University Hospital
Kita-ku, 761-0701, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Saiseikai Maebashi Hospital
Maebashi, 371-0821, Japan
Toranomon Hospital
Minatoku, 105-8470, Japan
Tokyo Saiseikai Central Hospital
Minatoku, 108-0073, Japan
Japanese Red Cross Musashino Hospital
Musashino-shi, 180-8610, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Meitetsu Hospital
Nagoya, 451-8511, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
International University of Health and Welfare Narita Hospital
Narita, 286-8520, Japan
Hyogo Medical University Hospital
Nishinomiya, 663-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka Keisatsu Hospital
Osaka, 543-0042, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
Ogaki Municipal Hospital
Ōgaki, 503-0864, Japan
Abe Clinic
Ōita, 870-0039, Japan
Oita Cardiovascular Hospital
Ōita, 870-0837, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, 856-8562, Japan
Saga University Hospital
Saga, 849-8501, Japan
Osaka Rosai Hospital
Sakai, 591-8025, Japan
Bell Land General Hospital
Sakai, 599-8247, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Jichi Medical University Hospital
Shimotsuke, 329-0498, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
National Center for Global Health and Medicine
Shinjyuku-ku, 162-8655, Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, 028-3695, Japan
Osaka Saiseikai Suita hospital
Suita, 564-0013, Japan
The University of Osaka Hospital
Suita, 565-0871, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
National Hospital Organization Takasaki General Medical Center
Takasaki, 370-0829, Japan
Tokyo Women's Medical University
Tokyo, 162-8666, Japan
Nagano Municipal Hospital
Tomitake, 381-8551, Japan
Sekino Hospital
Toshimaku, 171-0014, Japan
Ehime University Hospital
Tōon, 791-0295, Japan
Mie University Hospital
Tsu, 514-8507, Japan
National Hospital Organization Ureshino Medical Center
Ureshino, 843-0393, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Hospital Universiti Sains Malaysia
Kubang Kerian, 16150, Malaysia
University Malaya Medical Centre
Lembah Pantai, 59100, Malaysia
Medical Center Metas
Chihuahua City, 31110, Mexico
Centro de Investigación y Gastroenterología
Cuauhtémoc, 06700, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, 62250, Mexico
Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
Guadalajara, 44340, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, 44670, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA S.C.
Guadalajara, 44670, Mexico
Centro Médico Lic. Arturo Montiel Rojas ISSEMYM
Metepec, 52170, Mexico
Grupo Medico Camino Sc
Mexico City, 03310, Mexico
Centro de Investigación y Gastroenterología - S.C.
Mexico City, 03330, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, 11650, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
CEINV Salud
Monterrey, 64020, Mexico
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
Morelia, 58249, Mexico
Oncare Vasconcelos
San Pedro Garza García, 66220, Mexico
Avant Sante Research Center
San Pedro Garza García, 66260, Mexico
Fundación Santos y de la Garza Evía I.B.P
San Pedro Garza García, 66278, Mexico
Hospital General de Occidente
Zapopan, 45170, Mexico
Amsterdam UMC, locatie AMC
Amsterdam, 1105 AZ, Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Radboudumc
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
New Zealand Clinical Research (Auckland)
Auckland, 1010, New Zealand
Aotearoa Clinical Trials
Auckland, 2025, New Zealand
Aotearoa Clinical Trials - Whangarei
Whangarei, 0110, New Zealand
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, 9038, Norway
KRESMED Sp. z o.o.
Bialystok, 15-481, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600, Poland
Santa Familia PTG Lodz
Lodz, 90-302, Poland
ID Clinic
Mysłowice, 41-400, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej
Poznan, 60-354, Poland
Private Practice - Dr. Lukasz Krupa
Rzeszów, 35-055, Poland
NZOZ GynCentrum - Oddział Warszawa
Warsaw, 00-124, Poland
Przychodnie Care Access
Warsaw, 00-719, Poland
Szpital Czerniakowski
Warsaw, 00-737, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
Państwowy Instytut Medyczny MSWiA
Warsaw, 02-507, Poland
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501, Poland
ETG Zamość
Zamość, 22-400, Poland
Associação Protectora dos Diabéticos de Portugal
Lisbon, 1050-078, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Isis Clinical Research Center
Guaynabo, 00968, Puerto Rico
Klinical Investigations Group
San Juan, 00909, Puerto Rico
Delta Health Care
Bucharest, 014142, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, 400162, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, 900591, Romania
Spital Judetean de Urgenta
Satu Mare, 440055, Romania
Korea University Ansan Hospital
Ansan-si, 15355, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
Pusan National University Yangsan Hospital
Busan, 50612, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Chung-Ang University Hospital
Dongjak-gu, 06973, South Korea
Boramae Medical Center
Dongjak-gu, 07061, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Gyeongsang National University Hospital
Jinju, 52727, South Korea
Kyungpook National University Hospital
Junggu, 41944, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, 15405, Spain
Hospital Infanta Elena
Huelva, 21007, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
CHOP - Hospital Universitario Montecelo
Pontevedra, 36164, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39005, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clinico de Valencia
Valencia, 46010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Karolinska Universitetssjukhuset Huddinge
Huddinge, 141 86, Sweden
Universitetssjukhuset i Linköping
Linköping, 581 85, Sweden
University Hospital Basel
Basel, 4056, Switzerland
Luzern Kantonsspital
Lucerne, 6000, Switzerland
Kantonsspital Olten
Olten, 4600, Switzerland
Chiayi Christian Hospital
Chiayi City, 600, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
E-Da hospital
Kaohsiung City, 82445, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, 83301, Taiwan
Taipei Tzu Chi General Hospital
New Taipei City, 231, Taiwan
Fu Jen Catholic University Hospital
New Taipei City, 24352, Taiwan
China Medical University Hospital
Taichung, 404332, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Cathay General Hospital
Taipei, 106, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370, Turkey (Türkiye)
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi
Adana, 01790, Turkey (Türkiye)
Hacettepe Universitesi
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Bursa Şehir Hastanesi
Bursa, 16110, Turkey (Türkiye)
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi
Pendik, 34899, Turkey (Türkiye)
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100, Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, 61080, Turkey (Türkiye)
Clinical Diagnostic Center
Ivano-Frankivsk, 76018, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, 04050, Ukraine
Edelweiss Medics
Kyiv, 02002, Ukraine
Medical Center Ok!Clinic+
Kyiv, 02091, Ukraine
Medbud Clinic
Kyiv, 03037, Ukraine
Center of Family Medicine Plus
Kyiv, 04210, Ukraine
Progastro Clinic
Lviv, 79019, Ukraine
Medical Center Salutem
Vinnytsia, 21001, Ukraine
Limited liability company "Medical center Health Clinic"
Vinnytsia, 21009, Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T
Vinnytsia, 21018, Ukraine
CRZ Vidnovlennya
Zhytomyr, 10014, Ukraine
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
4 Medical Solutions, Ltd - Manchester
Clifton, M27 8FF, United Kingdom
Panthera Biopartners - North London
Enfield, EN3 4GS, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, G51 4RY, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
Royal London Hospital
London, E1 1FR, United Kingdom
4 Medical Solutions, Ltd - London
London, IG1 4HP, United Kingdom
Royal Free Hospital
London, NW32QG, United Kingdom
King's College Hospital
London, SE5 9RL, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
The John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Panthera Biopartners - Preston
Preston, PR2 9QB, United Kingdom
Panthera Biopartners - Manchester
Rochdale, OL11 4AU, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, S2 5FX, United Kingdom
Panthera Clinic - York
York, YO24 4LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2025
First Posted
September 10, 2025
Study Start
October 15, 2025
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
August 1, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.