Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
1 de outubro de 2026 atualizado 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
3200
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Amgen Call Center
- Número de telefone: 866-572-6436
- E-mail: medinfo@amgen.com
Locais de estudo
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New South Wales
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Botany, New South Wales, Austrália, 2019
- Recrutamento
- Emeritus Research Sydney
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Charlestown, New South Wales, Austrália, 2290
- Recrutamento
- Novatrials
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Miranda, New South Wales, Austrália, 2228
- Recrutamento
- Canopy Clinical Sutherland
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Miranda, New South Wales, Austrália, 2228
- Recrutamento
- Canopy Clinical Wollongong
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Queensland
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Meadowbrook, Queensland, Austrália, 4131
- Recrutamento
- Logan Hospital
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SAU
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Adelaide, SAU, Austrália, 5000
- Recrutamento
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Austrália, 3124
- Recrutamento
- Emeritus Research Camberwell
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North Altona, Victoria, Austrália, 3025
- Recrutamento
- Canopy Clinical Altona North
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Ontario
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Hamilton, Ontario, Canadá, L8L 5G8
- Recrutamento
- Wharton Medical Clinic
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Thunder Bay, Ontario, Canadá, P7B 6V4
- Recrutamento
- Curans Heart Center
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Quebec
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Chicoutimi, Quebec, Canadá, G7H 7K9
- Recrutamento
- Ecogene-21
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Alabama
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Anniston, Alabama, Estados Unidos, 36207
- Recrutamento
- Pinnacle Research Group LLC
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Daphne, Alabama, Estados Unidos, 36526
- Recrutamento
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, Estados Unidos, 36608
- Recrutamento
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, Estados Unidos, 92708
- Recrutamento
- Ark Clinical Research- Tustin
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Long Beach, California, Estados Unidos, 90806
- Recrutamento
- Long Beach Clinical Trials Services Inc
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Long Beach, California, Estados Unidos, 90815
- Recrutamento
- Ark Clinical Research- Long Beach
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Montclair, California, Estados Unidos, 91763
- Recrutamento
- Catalina Research Institute
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Riverside, California, Estados Unidos, 92503
- Recrutamento
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92103
- Recrutamento
- Artemis Institute for Clinical Research
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San Diego, California, Estados Unidos, 92120
- Recrutamento
- Apex Clinical Research
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Santa Ana, California, Estados Unidos, 92701
- Recrutamento
- Southern California Clinical Research
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Walnut Creek, California, Estados Unidos, 94598
- Recrutamento
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, Estados Unidos, 06708
- Recrutamento
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, Estados Unidos, 32216
- Recrutamento
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Estados Unidos, 32256
- Recrutamento
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill, Florida, Estados Unidos, 33351
- Recrutamento
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, Estados Unidos, 33173
- Recrutamento
- Research Institute of South Florida
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Miami, Florida, Estados Unidos, 33135
- Recrutamento
- Optimus U Corporation
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Miami Lakes, Florida, Estados Unidos, 33016
- Recrutamento
- Indago Research and Health Center
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Ocala, Florida, Estados Unidos, 34470
- Recrutamento
- Renstar Medical Research
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Orlando, Florida, Estados Unidos, 32801
- Recrutamento
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, Estados Unidos, 32825
- Recrutamento
- Florida Institute for Clinical Research
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Orlando, Florida, Estados Unidos, 32807
- Recrutamento
- Combined Research Orlando Phase I IV
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Weston, Florida, Estados Unidos, 33331
- Recrutamento
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, Estados Unidos, 30501
- Recrutamento
- Center for Advanced Research and Education
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Union City, Georgia, Estados Unidos, 30291
- Recrutamento
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96814
- Recrutamento
- East-West Medical Research
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
- Recrutamento
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, Estados Unidos, 60640
- Recrutamento
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, Estados Unidos, 60077
- Recrutamento
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, Estados Unidos, 60077
- Recrutamento
- Endeavor Health
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- Recrutamento
- JCCT- Juno Northwest Houston
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Newton, Kansas, Estados Unidos, 67114
- Recrutamento
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40213
- Recrutamento
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Recrutamento
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, Estados Unidos, 70072
- Recrutamento
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, Estados Unidos, 48034
- Recrutamento
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, Estados Unidos, 39069
- Recrutamento
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- Recrutamento
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Recrutamento
- Vector Clinical Trials
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Las Vegas, Nevada, Estados Unidos, 89148
- Recrutamento
- Palm Research Center Inc
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New York
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Binghamton, New York, Estados Unidos, 13905
- Recrutamento
- Velocity Clinical Research- Binghamton
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Rochester, New York, Estados Unidos, 14609
- Recrutamento
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, Estados Unidos, 28602
- Recrutamento
- Accellacare of Hickory
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Shelby, North Carolina, Estados Unidos, 28150
- Recrutamento
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- Recrutamento
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45212
- Recrutamento
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, Estados Unidos, 73069
- Recrutamento
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, Estados Unidos, 17074
- Recrutamento
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, Estados Unidos, 02818
- Recrutamento
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29607
- Recrutamento
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37909
- Recrutamento
- New Phase Research and Development
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Knoxville, Tennessee, Estados Unidos, 37938
- Recrutamento
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin, Texas, Estados Unidos, 78704
- Recrutamento
- Elligo Clinical Research Center
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Bellaire, Texas, Estados Unidos, 77401
- Recrutamento
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, Estados Unidos, 75251
- Recrutamento
- Cedar Health Research, LLC
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Dallas, Texas, Estados Unidos, 75235
- Recrutamento
- Cedar Health Research, LLC
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DeSoto, Texas, Estados Unidos, 75115
- Recrutamento
- Epic Medical Research - Red Oak
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El Paso, Texas, Estados Unidos, 79905
- Recrutamento
- Great Lakes Research Institute El Paso Research
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Houston, Texas, Estados Unidos, 77043
- Recrutamento
- Biopharma Informatic, LLC
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Mesquite, Texas, Estados Unidos, 75149
- Recrutamento
- Southern Endocrinology Associates PA
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Pharr, Texas, Estados Unidos, 78557
- Recrutamento
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, Estados Unidos, 78229
- Recrutamento
- Clinical Trials of Texas
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Sugar Land, Texas, Estados Unidos, 77479
- Recrutamento
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, Estados Unidos, 84010
- Recrutamento
- Pantheon Clinical Research
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Layton, Utah, Estados Unidos, 84041
- Recrutamento
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, Estados Unidos, 84790
- Recrutamento
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, Estados Unidos, 22206
- Recrutamento
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, Estados Unidos, 23606
- Recrutamento
- Health Research of Hampton Roads
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Winchester, Virginia, Estados Unidos, 22601
- Recrutamento
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, Estados Unidos, 53226
- Recrutamento
- Allegiance Research Specialists
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Kanagawa
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Yokohama, Kanagawa, Japão, 231-0023
- Recrutamento
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japão, 101-0041
- Recrutamento
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japão, 104-0031
- Recrutamento
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japão, 192-0046
- Recrutamento
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japão, 108-0075
- Recrutamento
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japão, 160-0004
- Recrutamento
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japão, 166-0003
- Recrutamento
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ponce, Porto Rico, 00716
- Recrutamento
- Ponce Medical School Foundation Inc
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Ponce, Porto Rico, 00717
- Recrutamento
- Puerto Rico Medical Research Inc.
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San Juan, Porto Rico, 00909
- Recrutamento
- Latin Clinical Trial Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
|
|
Comparador de Placebo: 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
Outros nomes:
|
|
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
Outros nomes:
|
|
Comparador de Placebo: 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
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
|
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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Prazo: 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)
Prazo: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Prazo: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Prazo: 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
Prazo: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de julho de 2026
Conclusão Primária (Estimado)
26 de dezembro de 2027
Conclusão do estudo (Estimado)
19 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
29 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de junho de 2026
Primeira postagem (Real)
6 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de outubro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de outubro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20250197
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .