Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
1 octobre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
3200
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Amgen Call Center
- Numéro de téléphone: 866-572-6436
- E-mail: medinfo@amgen.com
Lieux d'étude
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New South Wales
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Botany, New South Wales, Australie, 2019
- Recrutement
- Emeritus Research Sydney
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Charlestown, New South Wales, Australie, 2290
- Recrutement
- Novatrials
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Miranda, New South Wales, Australie, 2228
- Recrutement
- Canopy Clinical Sutherland
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Miranda, New South Wales, Australie, 2228
- Recrutement
- Canopy Clinical Wollongong
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Queensland
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Meadowbrook, Queensland, Australie, 4131
- Recrutement
- Logan Hospital
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SAU
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Adelaide, SAU, Australie, 5000
- Recrutement
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Australie, 3124
- Recrutement
- Emeritus Research Camberwell
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North Altona, Victoria, Australie, 3025
- Recrutement
- Canopy Clinical Altona North
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Ontario
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Hamilton, Ontario, Canada, L8L 5G8
- Recrutement
- Wharton Medical Clinic
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Thunder Bay, Ontario, Canada, P7B 6V4
- Recrutement
- Curans Heart Center
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
- Recrutement
- Ecogene-21
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Kanagawa
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Yokohama, Kanagawa, Japon, 231-0023
- Recrutement
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japon, 101-0041
- Recrutement
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japon, 104-0031
- Recrutement
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japon, 192-0046
- Recrutement
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japon, 108-0075
- Recrutement
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japon, 160-0004
- Recrutement
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japon, 166-0003
- Recrutement
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ponce, Porto Rico, 00716
- Recrutement
- Ponce Medical School Foundation Inc
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Ponce, Porto Rico, 00717
- Recrutement
- Puerto Rico Medical Research Inc.
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San Juan, Porto Rico, 00909
- Recrutement
- Latin Clinical Trial Center
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Alabama
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Anniston, Alabama, États-Unis, 36207
- Recrutement
- Pinnacle Research Group LLC
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Daphne, Alabama, États-Unis, 36526
- Recrutement
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, États-Unis, 36608
- Recrutement
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, États-Unis, 92708
- Recrutement
- Ark Clinical Research- Tustin
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Long Beach, California, États-Unis, 90806
- Recrutement
- Long Beach Clinical Trials Services Inc
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Long Beach, California, États-Unis, 90815
- Recrutement
- Ark Clinical Research- Long Beach
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Montclair, California, États-Unis, 91763
- Recrutement
- Catalina Research Institute
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Riverside, California, États-Unis, 92503
- Recrutement
- Artemis Institute for Clinical Research
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San Diego, California, États-Unis, 92103
- Recrutement
- Artemis Institute for Clinical Research
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San Diego, California, États-Unis, 92120
- Recrutement
- Apex Clinical Research
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Santa Ana, California, États-Unis, 92701
- Recrutement
- Southern California Clinical Research
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Walnut Creek, California, États-Unis, 94598
- Recrutement
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, États-Unis, 06708
- Recrutement
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, États-Unis, 32216
- Recrutement
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, États-Unis, 32256
- Recrutement
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill, Florida, États-Unis, 33351
- Recrutement
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, États-Unis, 33173
- Recrutement
- Research Institute of South Florida
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Miami, Florida, États-Unis, 33135
- Recrutement
- Optimus U Corporation
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Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Indago Research and Health Center
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Ocala, Florida, États-Unis, 34470
- Recrutement
- Renstar Medical Research
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Orlando, Florida, États-Unis, 32801
- Recrutement
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, États-Unis, 32825
- Recrutement
- Florida Institute for Clinical Research
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Orlando, Florida, États-Unis, 32807
- Recrutement
- Combined Research Orlando Phase I IV
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Weston, Florida, États-Unis, 33331
- Recrutement
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, États-Unis, 30501
- Recrutement
- Center for Advanced Research and Education
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Union City, Georgia, États-Unis, 30291
- Recrutement
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, États-Unis, 96814
- Recrutement
- East-West Medical Research
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Idaho
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Meridian, Idaho, États-Unis, 83646
- Recrutement
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, États-Unis, 60640
- Recrutement
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, États-Unis, 60077
- Recrutement
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, États-Unis, 60077
- Recrutement
- Endeavor Health
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Kansas
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Lenexa, Kansas, États-Unis, 66219
- Recrutement
- JCCT- Juno Northwest Houston
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Newton, Kansas, États-Unis, 67114
- Recrutement
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, États-Unis, 40213
- Recrutement
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70809
- Recrutement
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, États-Unis, 70072
- Recrutement
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, États-Unis, 48034
- Recrutement
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, États-Unis, 39069
- Recrutement
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, États-Unis, 64114
- Recrutement
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, États-Unis, 89128
- Recrutement
- Vector Clinical Trials
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Las Vegas, Nevada, États-Unis, 89148
- Recrutement
- Palm Research Center Inc
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New York
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Binghamton, New York, États-Unis, 13905
- Recrutement
- Velocity Clinical Research- Binghamton
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Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, États-Unis, 28602
- Recrutement
- Accellacare of Hickory
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Shelby, North Carolina, États-Unis, 28150
- Recrutement
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Recrutement
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, États-Unis, 45212
- Recrutement
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, États-Unis, 73069
- Recrutement
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, États-Unis, 17074
- Recrutement
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, États-Unis, 02818
- Recrutement
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, États-Unis, 29607
- Recrutement
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, États-Unis, 37909
- Recrutement
- New Phase Research and Development
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Knoxville, Tennessee, États-Unis, 37938
- Recrutement
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin, Texas, États-Unis, 78704
- Recrutement
- Elligo Clinical Research Center
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Bellaire, Texas, États-Unis, 77401
- Recrutement
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, États-Unis, 75251
- Recrutement
- Cedar Health Research, LLC
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Dallas, Texas, États-Unis, 75235
- Recrutement
- Cedar Health Research, LLC
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DeSoto, Texas, États-Unis, 75115
- Recrutement
- Epic Medical Research - Red Oak
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El Paso, Texas, États-Unis, 79905
- Recrutement
- Great Lakes Research Institute El Paso Research
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Houston, Texas, États-Unis, 77043
- Recrutement
- Biopharma Informatic, LLC
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Mesquite, Texas, États-Unis, 75149
- Recrutement
- Southern Endocrinology Associates PA
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Pharr, Texas, États-Unis, 78557
- Recrutement
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- Clinical Trials of Texas
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Sugar Land, Texas, États-Unis, 77479
- Recrutement
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, États-Unis, 84010
- Recrutement
- Pantheon Clinical Research
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Layton, Utah, États-Unis, 84041
- Recrutement
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, États-Unis, 84790
- Recrutement
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, États-Unis, 22206
- Recrutement
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, États-Unis, 23606
- Recrutement
- Health Research of Hampton Roads
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Winchester, Virginia, États-Unis, 22601
- Recrutement
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, États-Unis, 53226
- Recrutement
- Allegiance Research Specialists
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 99 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Comparateur 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. |
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Comparateur 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. |
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Délai: 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)
Délai: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Délai: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Délai: 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
Délai: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: MD, Amgen
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 juillet 2026
Achèvement primaire (Estimé)
26 décembre 2027
Achèvement de l'étude (Estimé)
19 mars 2028
Dates d'inscription aux études
Première soumission
29 juin 2026
Première soumission répondant aux critères de contrôle qualité
29 juin 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 octobre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20250197
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .