Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
2. september 2026 oppdatert 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).
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
3200
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-post: medinfo@amgen.com
Studiesteder
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New South Wales
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Botany, New South Wales, Australia, 2019
- Rekruttering
- Emeritus Research Sydney
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Charlestown, New South Wales, Australia, 2290
- Rekruttering
- Novatrials
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Miranda, New South Wales, Australia, 2228
- Rekruttering
- Canopy Clinical Sutherland
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Wollongong, New South Wales, Australia, 2500
- Rekruttering
- Canopy Clinical Wollongong
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South Australia
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Norwood, South Australia, Australia, 5067
- Rekruttering
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Australia, 3124
- Rekruttering
- Emeritus Research Camberwell
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North Altona, Victoria, Australia, 3025
- Rekruttering
- Canopy Clinical Altona North
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Rekruttering
- Pinnacle Research Group LLC
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Daphne, Alabama, Forente stater, 36526
- Rekruttering
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, Forente stater, 36608
- Rekruttering
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, Forente stater, 92708
- Rekruttering
- Ark Clinical Research- Tustin
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Long Beach, California, Forente stater, 90806
- Rekruttering
- Long Beach Clinical Trials Services Inc
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Long Beach, California, Forente stater, 90815
- Rekruttering
- Ark Clinical Research- Long Beach
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Montclair, California, Forente stater, 91763
- Rekruttering
- Catalina Research Institute
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Riverside, California, Forente stater, 92503
- Rekruttering
- Artemis Institute for Clinical Research
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San Diego, California, Forente stater, 92120
- Rekruttering
- Apex Clinical Research
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San Diego, California, Forente stater, 92123
- Rekruttering
- Artemis Institute for Clinical Research
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Santa Ana, California, Forente stater, 92701
- Rekruttering
- Southern California Clinical Research
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Walnut Creek, California, Forente stater, 94598
- Rekruttering
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, Forente stater, 06708
- Rekruttering
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, Forente stater, 32216
- Rekruttering
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Forente stater, 32256
- Rekruttering
- Clinical Neuroscience Solutions - Jacksonville
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Margate, Florida, Forente stater, 33063
- Rekruttering
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, Forente stater, 33173
- Rekruttering
- Research Institute of South Florida
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Miami, Florida, Forente stater, 33135
- Rekruttering
- Optimus U Corporation
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Miami Lakes, Florida, Forente stater, 33016
- Rekruttering
- Indago Research and Health Center
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Ocala, Florida, Forente stater, 34470
- Rekruttering
- Renstar Medical Research
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Orlando, Florida, Forente stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, Forente stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Orlando, Florida, Forente stater, 32807
- Rekruttering
- Combined Research Orlando Phase I IV
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Weston, Florida, Forente stater, 33331
- Rekruttering
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, Forente stater, 30501
- Rekruttering
- Center for Advanced Research and Education
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Union City, Georgia, Forente stater, 30291
- Rekruttering
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, Forente stater, 96814
- Rekruttering
- East-West Medical Research
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Idaho
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Meridian, Idaho, Forente stater, 83646
- Rekruttering
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, Forente stater, 60640
- Rekruttering
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, Forente stater, 60077
- Rekruttering
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, Forente stater, 60077
- Rekruttering
- Endeavor Health
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Kansas
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Newton, Kansas, Forente stater, 67114
- Rekruttering
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, Forente stater, 40213
- Rekruttering
- Monroe Biomedical Research
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Rekruttering
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, Forente stater, 70072
- Rekruttering
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, Forente stater, 48034
- Rekruttering
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, Forente stater, 39069
- Rekruttering
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, Forente stater, 64114
- Rekruttering
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
- Rekruttering
- Palm Research Center Inc
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Las Vegas, Nevada, Forente stater, 89128
- Rekruttering
- Vector Clinical Trials
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New York
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Binghamton, New York, Forente stater, 13905
- Rekruttering
- Velocity Clinical Research- Binghamton
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Rochester, New York, Forente stater, 14609
- Rekruttering
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, Forente stater, 28601
- Rekruttering
- Accellacare of Hickory
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Shelby, North Carolina, Forente stater, 28150
- Rekruttering
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Rekruttering
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Forente stater, 45212
- Rekruttering
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, Forente stater, 73069
- Rekruttering
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, Forente stater, 17074
- Rekruttering
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, Forente stater, 02818
- Rekruttering
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, Forente stater, 29607
- Rekruttering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, Forente stater, 37909
- Rekruttering
- New Phase Research and Development
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Texas
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Austin, Texas, Forente stater, 78704
- Rekruttering
- Elligo Clinical Research Center
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Bellaire, Texas, Forente stater, 77401
- Rekruttering
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, Forente stater, 75251
- Rekruttering
- Cedar Health Research, LLC
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DeSoto, Texas, Forente stater, 75115
- Rekruttering
- Epic Medical Research - Red Oak
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El Paso, Texas, Forente stater, 79936
- Rekruttering
- Great Lakes Research Institute El Paso Research
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Euless, Texas, Forente stater, 76040
- Rekruttering
- Cedar Health Research, LLC
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Houston, Texas, Forente stater, 77043
- Rekruttering
- Biopharma Informatic, LLC
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Houston, Texas, Forente stater, 77040
- Rekruttering
- JCCT- Juno Northwest Houston
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Mesquite, Texas, Forente stater, 75149
- Rekruttering
- Southern Endocrinology Associates PA
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Pharr, Texas, Forente stater, 78557
- Rekruttering
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Clinical Trials of Texas
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Sugar Land, Texas, Forente stater, 77479
- Rekruttering
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, Forente stater, 84010
- Rekruttering
- Pantheon Clinical Research
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Layton, Utah, Forente stater, 84041
- Rekruttering
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, Forente stater, 84770
- Rekruttering
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, Forente stater, 22206
- Rekruttering
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, Forente stater, 23606
- Rekruttering
- Health Research of Hampton Roads
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Winchester, Virginia, Forente stater, 22601
- Rekruttering
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, Forente stater, 53226
- Rekruttering
- Allegiance Research Specialists
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Kanagawa
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Yokohama, Kanagawa, Japan, 231-0023
- Rekruttering
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japan, 101-0041
- Rekruttering
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japan, 104-0031
- Rekruttering
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japan, 192-0046
- Rekruttering
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japan, 108-0075
- Rekruttering
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japan, 160-0004
- Rekruttering
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japan, 166-0003
- Rekruttering
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ponce, Puerto Rico, 00716
- Rekruttering
- Ponce Medical School Foundation Inc
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Ponce, Puerto Rico, 00717
- Rekruttering
- Puerto Rico Medical Research Inc.
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San Juan, Puerto Rico, 00909
- Rekruttering
- Latin Clinical Trial Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
|
Placebo komparator: 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.
|
Administreres subkutant.
|
|
Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
|
Placebo komparator: 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.
|
Administreres subkutant.
|
|
Eksperimentell: 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
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Tidsramme: 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)
Tidsramme: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Tidsramme: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Tidsramme: 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
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: MD, Amgen
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. juli 2026
Primær fullføring (Antatt)
26. desember 2027
Studiet fullført (Antatt)
19. mars 2028
Datoer for studieregistrering
Først innsendt
29. juni 2026
Først innsendt som oppfylte QC-kriteriene
29. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20250197
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .