Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
MARITIME-1
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
2 other identifiers
interventional
3,853
17 countries
243
Brief Summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Mar 2025
243 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
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 16, 2027
October 20, 2025
October 1, 2025
1.9 years
February 28, 2025
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 72
Baseline and Week 72
Secondary Outcomes (20)
Change From Baseline in Waist Circumference at Week 72
Baseline and Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Week 72
- +15 more secondary outcomes
Study Arms (4)
Maridebart Cafraglutide High Dose
EXPERIMENTALParticipants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Maridebart Cafraglutide Medium Dose
EXPERIMENTALParticipants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Maridebart Cafraglutide Low Dose
EXPERIMENTALParticipants will receive maridebart cafraglutide low dose SC for 72 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC for 72 weeks.
Interventions
Maridebart cafraglutide will be administered SC.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
You may not qualify if:
- Type 1 or Typ2 diabetes mellitus.
- Obesity induced by other endocrinologic disorders.
- Self-reported change in body weight \> 5 kg within 90 days before screening.
- Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
- History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- Lifetime history of suicide attempt.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (243)
Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Alliance For Multispecialty Research - Daphne
Daphne, Alabama, 36526, United States
Alliance for Multispecialty Research Mobile
Mobile, Alabama, 36608, United States
Avacare Foothills Research Center
Phoenix, Arizona, 85044, United States
Ark Clinical Research- Tustin
Fountain Valley, California, 92708, United States
Long Beach Clinical Trials Services Inc
Long Beach, California, 90806, United States
Ark Clinical Research- Long Beach
Long Beach, California, 90815, United States
Catalina Research Institute
Montclair, California, 91763, United States
Artemis Institute for Clinical Research
Riverside, California, 92503, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Apex Clinical Research
San Diego, California, 92120, United States
Southern California Clinical Research
Santa Ana, California, 92701, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256, United States
South Florida Wellness and Clinical Research Institute
Margate, Florida, 33063, United States
Optimus U Corporation
Miami, Florida, 33135, United States
Research Institute of South Florida
Miami, Florida, 33173, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Clinical Neuroscience Solutions - Orlando
Orlando, Florida, 32801, United States
Combined Research Orlando Phase I IV
Orlando, Florida, 32807, United States
Florida Institute for Clinical Research
Orlando, Florida, 32825, United States
Encore Medical Research of Weston LLC
Weston, Florida, 33331, United States
Center for Advanced Research and Education
Gainesville, Georgia, 30501, United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, 30291, United States
East-West Medical Research
Honolulu, Hawaii, 96814, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Flourish Research - Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois, 60077, United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, 60077, United States
Alliance for Multispecialty Research Newton
Newton, Kansas, 67114, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213, United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, 70072, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Prime Health and Wellness Sky Clinical Research Network Group
Fayette, Mississippi, 39069, United States
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114, United States
Palm Research Center Inc
Las Vegas, Nevada, 89128, United States
Vector Clinical Trials
Las Vegas, Nevada, 89128, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Velocity Clinical Research- Binghamton
Vestal, New York, 13850, United States
Accellacare of Hickory
Hickory, North Carolina, 28601, United States
Carolina Research Center Inc
Shelby, North Carolina, 28150, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio, 45212, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219, United States
Alliance for Multispecialty Research - Norman
Norman, Oklahoma, 73069, United States
Capital Area Research LLC
Newport, Pennsylvania, 17074, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818, United States
Tribe Clinical Research LLC Dba Mountain View Clinical Research
Greenville, South Carolina, 29607, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37938, United States
Elligo Clinical Research Center
Austin, Texas, 78704, United States
Cedar Health Research, LLC
Dallas, Texas, 75251, United States
Epic Medical Research - Texas
DeSoto, Texas, 75115, United States
Great Lakes Research Institute El Paso Research
El Paso, Texas, 79936, United States
Cedar Health Research, LLC
Euless, Texas, 76040, United States
Juno Research LLC
Houston, Texas, 77040, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Juno Research LLC
Houston, Texas, 77054, United States
Southern Endocrinology Associates PA
Mesquite, Texas, 75149, United States
Great Lakes Research Institute - McAllen Research
Pharr, Texas, 78557, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Sugar Lakes Family Practice
Sugar Land, Texas, 77479, United States
Pantheon Clinical Research
Bountiful, Utah, 84010, United States
Alliance for Multispecialty Research Layton Research Center
Layton, Utah, 84041, United States
Chrysalis Clinical Research, LLC
St. George, Utah, 84770, United States
Washington Center for Weight Management and Research, Inc
Arlington, Virginia, 22206, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
Selma Medical Associates
Winchester, Virginia, 22601, United States
Allegiance Research Specialists
Milwaukee, Wisconsin, 53226, United States
Cedic - Centro de Investigacion Clinica
CABA, Buenos Aires, 1060, Argentina
Centro Medico Viamonte
CABA, Buenos Aires, 1120, Argentina
Cemedic Centro de Especialidades Medicas
CABA, Buenos Aires, C1407GTN, Argentina
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
CABA, Buenos Aires, C1425AGC, Argentina
Consultorios Medicos Dr Besada
CABA, Buenos Aires, C1426ABP, Argentina
Fundacion Respirar
CABA, Buenos Aires, C1426ABP, Argentina
Cinme - Centro de Investigaciones Metabolicas
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABI, Argentina
Ciprec - Centro de Investigacion y Prevencion Cardiovascular
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAT, Argentina
Emeritus Research Sydney
Botany, New South Wales, 2019, Australia
Novatrials
Charlestown, New South Wales, 2290, Australia
Canopy Clinical Sutherland
Miranda, New South Wales, 2228, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Canopy Clinical Wollongong
Wollongong, New South Wales, 2500, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Fusion Clinical Research
Norwood, South Australia, 5067, Australia
Southern Adelaide Diabetes and Endocrine Services
Oaklands Park, South Australia, 5046, Australia
Emeritus Research Camberwell
Camberwell, Victoria, 3124, Australia
Austin Health, Heidelberg Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
Canopy Clinical Altona North
North Altona, Victoria, 3025, Australia
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, 8500, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Algemeen Ziekenhuis Sint-Maarten
Mechelen, 2800, Belgium
Centres Hospitaliers Universitaires HELORA - Hôpital de Mons - Site Constantinople
Mons, 7000, Belgium
tlc Diabetes and Endocrinology
Surrey, British Columbia, V3T 2V6, Canada
Wharton Medical Clinic
Hamilton, Ontario, L8L 5G8, Canada
North York Diagnostic and Cardiac Centre
North York, Ontario, M6B 3H7, Canada
Centricity Research Oshawa Multispecialty
Oshawa, Ontario, L1J 2K9, Canada
Heart Health Institute Research Incorporated
Scarborough Village, Ontario, M1B 4Z8, Canada
Curans Heart Center
Thunder Bay, Ontario, P7B 5N3, Canada
Centricity Research Toronto
Toronto, Ontario, M4G 3E8, Canada
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Institut Universitaire de cardiologie et de pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
CardioVasc HR Incorporated
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Centre de Medecine Metabolique de Lanaudiere
Terrebonne, Quebec, J6X 4P7, Canada
Medicus Services sro
Brandýs nad Labem, 250 01, Czechia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Endohope Havirov sro
Havířov, 736 01, Czechia
PreventaMed sro
Olomouc, 779 00, Czechia
CCR Ostrava sro
Ostrava, 702 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Ob klinika as
Prague, 130 00, Czechia
Institut klinicke a experimentalni mediciny
Prague, 140 21, Czechia
Endohope klinika sro
Prague, 150 00, Czechia
Endokrinologie Cerny Most sro
Prague, 198 00, Czechia
Sanos Gandrup
Gandrup, 9362, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Sanos Clinic
Herlev, 2730, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Regionshospitalet Godstrup
Herning, 7400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Obesity Research Unit
Helsinki, 02290, Finland
Health Step Finland
Kuopio, 70211, Finland
Oulu University Hospital
Oulu, 90220, Finland
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Kardiologische Praxis Dr med Wolfgang Jungmair
Bad Homburg, 61348, Germany
Universitaets-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189, Germany
Diabetespraxis Bad Mergentheim
Bad Mergentheim, 97980, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum
Bad Oeynhausen, 32545, Germany
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
Velocity Clinical Research GmbH
Berlin, 10787, Germany
Diabetespraxis Dr. Hermann Braun
Berlin, 13187, Germany
Mvz am Bahnhof Spandau
Berlin, 13597, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Zentrum fuer Klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04190, Germany
InnoDiab Forschung
Essen, 45136, Germany
Praxis am Markt Dr. Bernd Becker
Essen, 45355, Germany
Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin
Falkensee, 14612, Germany
ClinPhenomics CVC GmbH
Frankfurt am Main, 60596, Germany
Diabeteszentrum Hamburg West
Hamburg, 22607, Germany
Endokrinologikum Hamburg
Hamburg, 22767, Germany
Diabetologische Schwerpunktpraxis Hohenmoelsen
Hohenmölsen, 06679, Germany
Braun Ambulantes Herzzentrum Kassel
Kassel, 34121, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Universitaetsklinikum Schleswig-Holstein - Luebeck
Lübeck, 23538, Germany
Marienhaus Klinikum Mainz
Mainz, 55131, Germany
Kardiologische Praxis Doktor Jens Taggeselle
Markkleeberg, 04416, Germany
Centrum für Diagnostik und Gesundheit
München, 80809, Germany
Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster
Münster, 48145, Germany
Praxis Segner - Dr. Braun - Kirsch
Oberwürzbach, 66386, Germany
Red-Institut GmbH
Oldenburg, 23758, Germany
Gemeinschaftspraxis Prof Jacob/ Dr Jacob
Villingen-Schwenningen, 78048, Germany
Zentrum fuer klinische Forschung Allgaeu Oberschwaben
Wangen, 88239, Germany
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, 40138, Italy
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
Chieti, 66100, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
IRCCS Centro Cardiologico Monzino
Milan, 20138, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
Milan, 20157, Italy
Ospedale Civico, Di Cristina e Benfratelli
Palermo, 90127, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Fondazione Policlinico Tor Vergata
Roma, 00133, Italy
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Yokohama, Kanagawa, 231-0023, Japan
Doujin Memorial Foundation, Meiwa Hospital
Chiyoda-ku, Tokyo, 101-0041, Japan
Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Medical Corp Seikoukai New Medical Research System Clinic
Hachioji-shi, Tokyo, 192-0046, Japan
Medical Corporation AOT Shinagawa Strings Clinic
Minato-ku, Tokyo, 108-0075, Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, 160-0004, Japan
Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
Suginami-ku, Tokyo, 166-0003, Japan
Gabinet Leczenia Otylosci i Chorob Dietozaleznych dr hab n med Lucyna Ostrowska
Bialystok, 15-281, Poland
Kresmed Spolka z Ograniczona Odpowiedzialnoscia
Bialystok, 15-481, Poland
Etg Lublin Spzoo
Dębica, 39-200, Poland
Futuremeds Spolka z ograniczona odpowiedzialnoscia
Gdynia, 81-384, Poland
Uniwersyteckie Centrum Kliniczne im Prof K Gibinskiego Slaskiego UM w Katowicach
Katowice, 40-752, Poland
Salvia-Lekston i Madej Spolka Jawna
Katowice, 40-772, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338, Poland
Ekamed Spolka z Ograniczona Odpowiedzialnoscia
Lublin, 20-718, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, 60-589, Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 61-731, Poland
Futuremeds Spolka z ograniczona odpowiedzialnoscia
Warsaw, 00-215, Poland
Clinical Best Solutions Sp zoo Spolka komandytowa
Warsaw, 00-710, Poland
Ponce Medical School Foundation Inc
Ponce, 00716, Puerto Rico
Puerto Rico Medical Research Inc.
Ponce, 00717, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Wellness Clinical Research Vega Baja
Vega Baja, 00694, Puerto Rico
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068, South Korea
The Catholic University of Korea Bucheon St Marys Hospital
Bucheon, Gyeonggi-do, 14647, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
KyungHee University Gangdong Hospital
Seoul, 05278, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
The Catholic University of Korea Yeouido St Marys Hospital
Seoul, 07345, South Korea
Ajou University Hospital
Suwon-si Gyeonggi-do, 16499, South Korea
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do, 50612, South Korea
Centro Periferico de Especialidades Bola Azul
Almería, Andalusia, 04009, Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, Andalusia, 41950, Spain
Hospital Infanta Elena
Huelva, Andalusia, 21007, Spain
Hospital Virgen del Camino
Sanlúcar de Barrameda, Andalusia, 11540, Spain
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, Andalusia, 41003, Spain
Hospital Quironsalud Infanta Luisa
Seville, Andalusia, 41010, Spain
Hospital Medico Quirurgico San Rafael
A Coruña, Galicia, 15006, Spain
Clinica Ruber SA
Pozuelo de Alarcón, Madrid, 28223, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Clinica Juaneda
Palma, 07014, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Universitaetsspital Basel
Basel, 4031, Switzerland
Hopitaux Universitaires de Geneve
Geneva, 1211, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, 9007, Switzerland
Stoffwechselzentrum Sankt Gallen
Sankt Gallen, 9016, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Ormeau Clinical Trials Ltd
Belfast, BT28BG, United Kingdom
FutureMeds Birmingham
Birmingham, B21 9RY, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
Waterloo Medical Centre
Blackpool, FY4 3AD, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
The Rame Group Practice
Cornwall, PL11 2TB, United Kingdom
Staploe Medical Centre
Ely, CB7 5JD, United Kingdom
FutureMeds Glasgow
Glasgow, G20 7BE, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre
Leicester, LE5 4PW, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
FutureMeds Newcastle
Newcastle upon Tyne, NE6 1SG, United Kingdom
Atlantic Medical Group
Penzance, TR183DX, United Kingdom
Clifton Medical Centre
Rotherham, S65 1DA, United Kingdom
Ashfields Primary Care Centre
Sandbach, CW11 1EQ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 5, 2025
Study Start
March 12, 2025
Primary Completion (Estimated)
January 21, 2027
Study Completion (Estimated)
April 16, 2027
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.