Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
1 oktober 2026 uppdaterad av: 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).
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
3200
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-post: medinfo@amgen.com
Studieorter
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New South Wales
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Botany, New South Wales, Australien, 2019
- Rekrytering
- Emeritus Research Sydney
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Charlestown, New South Wales, Australien, 2290
- Rekrytering
- Novatrials
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Miranda, New South Wales, Australien, 2228
- Rekrytering
- Canopy Clinical Sutherland
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Miranda, New South Wales, Australien, 2228
- Rekrytering
- Canopy Clinical Wollongong
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Queensland
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Meadowbrook, Queensland, Australien, 4131
- Rekrytering
- Logan Hospital
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SAU
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Adelaide, SAU, Australien, 5000
- Rekrytering
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Australien, 3124
- Rekrytering
- Emeritus Research Camberwell
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North Altona, Victoria, Australien, 3025
- Rekrytering
- Canopy Clinical Altona North
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Alabama
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Anniston, Alabama, Förenta staterna, 36207
- Rekrytering
- Pinnacle Research Group LLC
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Daphne, Alabama, Förenta staterna, 36526
- Rekrytering
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, Förenta staterna, 36608
- Rekrytering
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, Förenta staterna, 92708
- Rekrytering
- Ark Clinical Research- Tustin
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Long Beach, California, Förenta staterna, 90806
- Rekrytering
- Long Beach Clinical Trials Services Inc
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Long Beach, California, Förenta staterna, 90815
- Rekrytering
- Ark Clinical Research- Long Beach
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Montclair, California, Förenta staterna, 91763
- Rekrytering
- Catalina Research Institute
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Riverside, California, Förenta staterna, 92503
- Rekrytering
- Artemis Institute for Clinical Research
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San Diego, California, Förenta staterna, 92103
- Rekrytering
- Artemis Institute for Clinical Research
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San Diego, California, Förenta staterna, 92120
- Rekrytering
- Apex Clinical Research
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Santa Ana, California, Förenta staterna, 92701
- Rekrytering
- Southern California Clinical Research
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Walnut Creek, California, Förenta staterna, 94598
- Rekrytering
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, Förenta staterna, 06708
- Rekrytering
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, Förenta staterna, 32216
- Rekrytering
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Förenta staterna, 32256
- Rekrytering
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill, Florida, Förenta staterna, 33351
- Rekrytering
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, Förenta staterna, 33173
- Rekrytering
- Research Institute of South Florida
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Miami, Florida, Förenta staterna, 33135
- Rekrytering
- Optimus U Corporation
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Miami Lakes, Florida, Förenta staterna, 33016
- Rekrytering
- Indago Research and Health Center
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Ocala, Florida, Förenta staterna, 34470
- Rekrytering
- Renstar Medical Research
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Orlando, Florida, Förenta staterna, 32801
- Rekrytering
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, Förenta staterna, 32825
- Rekrytering
- Florida Institute for Clinical Research
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Orlando, Florida, Förenta staterna, 32807
- Rekrytering
- Combined Research Orlando Phase I IV
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Weston, Florida, Förenta staterna, 33331
- Rekrytering
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, Förenta staterna, 30501
- Rekrytering
- Center for Advanced Research and Education
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Union City, Georgia, Förenta staterna, 30291
- Rekrytering
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96814
- Rekrytering
- East-West Medical Research
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Idaho
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Meridian, Idaho, Förenta staterna, 83646
- Rekrytering
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, Förenta staterna, 60640
- Rekrytering
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, Förenta staterna, 60077
- Rekrytering
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, Förenta staterna, 60077
- Rekrytering
- Endeavor Health
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Kansas
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Lenexa, Kansas, Förenta staterna, 66219
- Rekrytering
- JCCT- Juno Northwest Houston
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Newton, Kansas, Förenta staterna, 67114
- Rekrytering
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40213
- Rekrytering
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Rekrytering
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, Förenta staterna, 70072
- Rekrytering
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, Förenta staterna, 48034
- Rekrytering
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, Förenta staterna, 39069
- Rekrytering
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, Förenta staterna, 64114
- Rekrytering
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89128
- Rekrytering
- Vector Clinical Trials
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Las Vegas, Nevada, Förenta staterna, 89148
- Rekrytering
- Palm Research Center Inc
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New York
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Binghamton, New York, Förenta staterna, 13905
- Rekrytering
- Velocity Clinical Research- Binghamton
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Rochester, New York, Förenta staterna, 14609
- Rekrytering
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, Förenta staterna, 28602
- Rekrytering
- Accellacare of Hickory
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Shelby, North Carolina, Förenta staterna, 28150
- Rekrytering
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Förenta staterna, 45212
- Rekrytering
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, Förenta staterna, 73069
- Rekrytering
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, Förenta staterna, 17074
- Rekrytering
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, Förenta staterna, 02818
- Rekrytering
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29607
- Rekrytering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37909
- Rekrytering
- New Phase Research and Development
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Knoxville, Tennessee, Förenta staterna, 37938
- Rekrytering
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin, Texas, Förenta staterna, 78704
- Rekrytering
- Elligo Clinical Research Center
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Bellaire, Texas, Förenta staterna, 77401
- Rekrytering
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, Förenta staterna, 75251
- Rekrytering
- Cedar Health Research, LLC
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Dallas, Texas, Förenta staterna, 75235
- Rekrytering
- Cedar Health Research, LLC
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DeSoto, Texas, Förenta staterna, 75115
- Rekrytering
- Epic Medical Research - Red Oak
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El Paso, Texas, Förenta staterna, 79905
- Rekrytering
- Great Lakes Research Institute El Paso Research
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Houston, Texas, Förenta staterna, 77043
- Rekrytering
- Biopharma Informatic, LLC
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Mesquite, Texas, Förenta staterna, 75149
- Rekrytering
- Southern Endocrinology Associates PA
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Pharr, Texas, Förenta staterna, 78557
- Rekrytering
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Clinical Trials of Texas
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Sugar Land, Texas, Förenta staterna, 77479
- Rekrytering
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Rekrytering
- Pantheon Clinical Research
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Layton, Utah, Förenta staterna, 84041
- Rekrytering
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, Förenta staterna, 84790
- Rekrytering
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, Förenta staterna, 22206
- Rekrytering
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, Förenta staterna, 23606
- Rekrytering
- Health Research of Hampton Roads
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Winchester, Virginia, Förenta staterna, 22601
- Rekrytering
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Allegiance Research Specialists
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Kanagawa
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Yokohama, Kanagawa, Japan, 231-0023
- Rekrytering
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japan, 101-0041
- Rekrytering
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japan, 104-0031
- Rekrytering
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japan, 192-0046
- Rekrytering
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japan, 108-0075
- Rekrytering
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japan, 160-0004
- Rekrytering
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japan, 166-0003
- Rekrytering
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ontario
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Hamilton, Ontario, Kanada, L8L 5G8
- Rekrytering
- Wharton Medical Clinic
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Thunder Bay, Ontario, Kanada, P7B 6V4
- Rekrytering
- Curans Heart Center
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Quebec
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Chicoutimi, Quebec, Kanada, G7H 7K9
- Rekrytering
- Ecogene-21
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Ponce, Puerto Rico, 00716
- Rekrytering
- Ponce Medical School Foundation Inc
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Ponce, Puerto Rico, 00717
- Rekrytering
- Puerto Rico Medical Research Inc.
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San Juan, Puerto Rico, 00909
- Rekrytering
- Latin Clinical Trial Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 99 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Placebo-jämförare: 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. |
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Placebo-jämförare: 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. |
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Tidsram: 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)
Tidsram: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Tidsram: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Tidsram: 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
Tidsram: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: MD, Amgen
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 juli 2026
Primärt slutförande (Beräknad)
26 december 2027
Avslutad studie (Beräknad)
19 mars 2028
Studieregistreringsdatum
Först inskickad
29 juni 2026
Först inskickad som uppfyllde QC-kriterierna
29 juni 2026
Första postat (Faktisk)
6 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 oktober 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20250197
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .