Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
1 de octubre de 2026 actualizado por: Amgen
A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
3200
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Amgen Call Center
- Número de teléfono: 866-572-6436
- Correo electrónico: medinfo@amgen.com
Ubicaciones de estudio
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New South Wales
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Botany, New South Wales, Australia, 2019
- Reclutamiento
- Emeritus Research Sydney
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Charlestown, New South Wales, Australia, 2290
- Reclutamiento
- Novatrials
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Miranda, New South Wales, Australia, 2228
- Reclutamiento
- Canopy Clinical Sutherland
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Miranda, New South Wales, Australia, 2228
- Reclutamiento
- Canopy Clinical Wollongong
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Queensland
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Meadowbrook, Queensland, Australia, 4131
- Reclutamiento
- Logan Hospital
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SAU
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Adelaide, SAU, Australia, 5000
- Reclutamiento
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Reclutamiento
- Emeritus Research Camberwell
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North Altona, Victoria, Australia, 3025
- Reclutamiento
- Canopy Clinical Altona North
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Ontario
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Hamilton, Ontario, Canadá, L8L 5G8
- Reclutamiento
- Wharton Medical Clinic
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Thunder Bay, Ontario, Canadá, P7B 6V4
- Reclutamiento
- Curans Heart Center
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Quebec
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Chicoutimi, Quebec, Canadá, G7H 7K9
- Reclutamiento
- Ecogene-21
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Reclutamiento
- Pinnacle Research Group LLC
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Daphne, Alabama, Estados Unidos, 36526
- Reclutamiento
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, Estados Unidos, 36608
- Reclutamiento
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, Estados Unidos, 92708
- Reclutamiento
- Ark Clinical Research- Tustin
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Long Beach, California, Estados Unidos, 90806
- Reclutamiento
- Long Beach Clinical Trials Services Inc
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Long Beach, California, Estados Unidos, 90815
- Reclutamiento
- Ark Clinical Research- Long Beach
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Montclair, California, Estados Unidos, 91763
- Reclutamiento
- Catalina Research Institute
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Riverside, California, Estados Unidos, 92503
- Reclutamiento
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92103
- Reclutamiento
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92120
- Reclutamiento
- Apex Clinical Research
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Santa Ana, California, Estados Unidos, 92701
- Reclutamiento
- Southern California Clinical Research
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Walnut Creek, California, Estados Unidos, 94598
- Reclutamiento
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, Estados Unidos, 06708
- Reclutamiento
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Reclutamiento
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Estados Unidos, 32256
- Reclutamiento
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill, Florida, Estados Unidos, 33351
- Reclutamiento
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, Estados Unidos, 33173
- Reclutamiento
- Research Institute of South Florida
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Miami, Florida, Estados Unidos, 33135
- Reclutamiento
- Optimus U Corporation
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Miami Lakes, Florida, Estados Unidos, 33016
- Reclutamiento
- Indago Research and Health Center
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Ocala, Florida, Estados Unidos, 34470
- Reclutamiento
- Renstar Medical Research
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Orlando, Florida, Estados Unidos, 32801
- Reclutamiento
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, Estados Unidos, 32825
- Reclutamiento
- Florida Institute for Clinical Research
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Orlando, Florida, Estados Unidos, 32807
- Reclutamiento
- Combined Research Orlando Phase I IV
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Weston, Florida, Estados Unidos, 33331
- Reclutamiento
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, Estados Unidos, 30501
- Reclutamiento
- Center for Advanced Research and Education
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Union City, Georgia, Estados Unidos, 30291
- Reclutamiento
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96814
- Reclutamiento
- East-West Medical Research
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
- Reclutamiento
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, Estados Unidos, 60640
- Reclutamiento
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, Estados Unidos, 60077
- Reclutamiento
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, Estados Unidos, 60077
- Reclutamiento
- Endeavor Health
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- Reclutamiento
- JCCT- Juno Northwest Houston
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Newton, Kansas, Estados Unidos, 67114
- Reclutamiento
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40213
- Reclutamiento
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Reclutamiento
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, Estados Unidos, 70072
- Reclutamiento
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, Estados Unidos, 48034
- Reclutamiento
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, Estados Unidos, 39069
- Reclutamiento
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- Reclutamiento
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Reclutamiento
- Vector Clinical Trials
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Las Vegas, Nevada, Estados Unidos, 89148
- Reclutamiento
- Palm Research Center Inc
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New York
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Binghamton, New York, Estados Unidos, 13905
- Reclutamiento
- Velocity Clinical Research- Binghamton
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Rochester, New York, Estados Unidos, 14609
- Reclutamiento
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, Estados Unidos, 28602
- Reclutamiento
- Accellacare of Hickory
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Shelby, North Carolina, Estados Unidos, 28150
- Reclutamiento
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- Reclutamiento
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45212
- Reclutamiento
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, Estados Unidos, 73069
- Reclutamiento
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, Estados Unidos, 17074
- Reclutamiento
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, Estados Unidos, 02818
- Reclutamiento
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Reclutamiento
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37909
- Reclutamiento
- New Phase Research and Development
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Knoxville, Tennessee, Estados Unidos, 37938
- Reclutamiento
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin, Texas, Estados Unidos, 78704
- Reclutamiento
- Elligo Clinical Research Center
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Bellaire, Texas, Estados Unidos, 77401
- Reclutamiento
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, Estados Unidos, 75251
- Reclutamiento
- Cedar Health Research, LLC
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Dallas, Texas, Estados Unidos, 75235
- Reclutamiento
- Cedar Health Research, LLC
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DeSoto, Texas, Estados Unidos, 75115
- Reclutamiento
- Epic Medical Research - Red Oak
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El Paso, Texas, Estados Unidos, 79905
- Reclutamiento
- Great Lakes Research Institute El Paso Research
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Houston, Texas, Estados Unidos, 77043
- Reclutamiento
- Biopharma Informatic, LLC
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Mesquite, Texas, Estados Unidos, 75149
- Reclutamiento
- Southern Endocrinology Associates PA
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Pharr, Texas, Estados Unidos, 78557
- Reclutamiento
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- Clinical Trials of Texas
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Sugar Land, Texas, Estados Unidos, 77479
- Reclutamiento
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Reclutamiento
- Pantheon Clinical Research
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Layton, Utah, Estados Unidos, 84041
- Reclutamiento
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, Estados Unidos, 84790
- Reclutamiento
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, Estados Unidos, 22206
- Reclutamiento
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, Estados Unidos, 23606
- Reclutamiento
- Health Research of Hampton Roads
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Winchester, Virginia, Estados Unidos, 22601
- Reclutamiento
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, Estados Unidos, 53226
- Reclutamiento
- Allegiance Research Specialists
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Kanagawa
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Yokohama, Kanagawa, Japón, 231-0023
- Reclutamiento
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japón, 101-0041
- Reclutamiento
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japón, 104-0031
- Reclutamiento
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japón, 192-0046
- Reclutamiento
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japón, 108-0075
- Reclutamiento
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japón, 160-0004
- Reclutamiento
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japón, 166-0003
- Reclutamiento
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ponce, Puerto Rico, 00716
- Reclutamiento
- Ponce Medical School Foundation Inc
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Ponce, Puerto Rico, 00717
- Reclutamiento
- Puerto Rico Medical Research Inc.
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San Juan, Puerto Rico, 00909
- Reclutamiento
- Latin Clinical Trial Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Completed the parent trial (2010181)
- Completed week 72 visit in parent trial
- Did not permanently discontinue trial intervention in parent trial
- Randomized within 7 Days of week 72 visit in the parent trial
- Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention
Exclusion Criteria:
- Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
- Body mass index ≤ 18.5 kilograms per meter square (kg/m^2)
- Participant has known sensitivity to any of the products or components to be administered during dosing
- History of ischemic optic neuropathy
- Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
- Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative[s]) history of medullary thyroid cancer.
- Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
- Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.
- Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
- History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or
- Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
- Major surgical procedures planned during the trial.
- Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
- Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Maridebart Cafraglutide Medium Dose Q4W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously
Otros nombres:
|
|
Comparador de placebos: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
|
Experimental: Maridebart Cafraglutide High Dose Q4W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously
Otros nombres:
|
|
Experimental: Maridebart Cafraglutide High Dose Q8W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W. |
Administered subcutaneously
Otros nombres:
|
|
Comparador de placebos: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
|
Experimental: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses. |
Administered subcutaneously
Otros nombres:
|
|
Experimental: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W. |
Administered subcutaneously
Otros nombres:
|
|
Experimental: Maridebart Cafraglutide Low Dose Q4W
Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 [NCT06858839]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W). |
Administered subcutaneously
Otros nombres:
|
|
Experimental: Maridebart Cafraglutide Medium Dose Q8W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8weeks (Q8W). |
Administered subcutaneously
Otros nombres:
|
|
Experimental: Maridebart Cafraglutide High Dose Q12W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC once in 12 weeks (Q12W). |
Administered subcutaneously
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Periodo de tiempo: Baseline of parent trial (20210181) to Week 48 of current trial
|
Baseline of parent trial (20210181) to Week 48 of current trial
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Change from Baseline of the Parent Trial in Waist Circumference
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percent Change from Baseline in Body Weight
Periodo de tiempo: Baseline of current trial to Week 48
|
Baseline of current trial to Week 48
|
|
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Periodo de tiempo: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Periodo de tiempo: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
Periodo de tiempo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: MD, Amgen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de julio de 2026
Finalización primaria (Estimado)
26 de diciembre de 2027
Finalización del estudio (Estimado)
19 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de octubre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20250197
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .