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Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)

10. juni 2026 opdateret af: Amgen

A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight

Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Pelham, Alabama, Forenede Stater, 35124
        • Rekruttering
        • Cahaba Research, Inc.
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Rekruttering
        • Arizona Clinical Trials
      • Sun City, Arizona, Forenede Stater, 85351
        • Rekruttering
        • Epic Medical Research - Sun City
    • California
      • Palm Springs, California, Forenede Stater, 92262
        • Rekruttering
        • Desert Oasis Healthcare Medical Group
      • Rialto, California, Forenede Stater, 92377
        • Rekruttering
        • Inland Empire Liver Foundation
      • Rolling Hills Estates, California, Forenede Stater, 90274
        • Rekruttering
        • Peninsula Research Associates
      • San Diego, California, Forenede Stater, 92120
        • Rekruttering
        • Apex Clinical Research
      • Santa Ana, California, Forenede Stater, 92701
        • Rekruttering
        • Southern California Clinical Research
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Rekruttering
        • Aga Clinical Trials
      • Margate, Florida, Forenede Stater, 33063
        • Rekruttering
        • South Florida Clinical Research
      • Miami, Florida, Forenede Stater, 33165
        • Rekruttering
        • New Horizon Research Center
      • Miami, Florida, Forenede Stater, 33173
        • Rekruttering
        • Research Institute of South Florida
      • Orlando, Florida, Forenede Stater, 32801
        • Rekruttering
        • Clinical Neuroscience Solutions
      • Orlando, Florida, Forenede Stater, 32825
        • Rekruttering
        • Florida Institute for Clinical research
      • Port Orange, Florida, Forenede Stater, 32127
        • Rekruttering
        • Progressive Medical Research
      • The Villages, Florida, Forenede Stater, 32162
        • Rekruttering
        • Charter Research - The Villages
    • Georgia
      • Johns Creek, Georgia, Forenede Stater, 30024
        • Rekruttering
        • Nsc Research
      • Union City, Georgia, Forenede Stater, 30291
        • Rekruttering
        • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
      • Woodstock, Georgia, Forenede Stater, 30189
        • Rekruttering
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Rekruttering
        • Solaris Clinical Research
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
        • Rekruttering
        • Endeavor Health
    • Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Rekruttering
        • Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland, Mississippi, Forenede Stater, 39157
        • Rekruttering
        • Sky Integrative Medical Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Rekruttering
        • Excel Clinical Research
    • New York
      • Rochester, New York, Forenede Stater, 14609
        • Rekruttering
        • Rochester Clinical Research
    • North Carolina
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Rekruttering
        • Centricity Research Morehead City Specialty
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Rekruttering
        • Accellacare of Raleigh
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • Accellacare Research of Wilmington
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Rekruttering
        • Lynn Health Science Institute
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Rekruttering
        • Altoona Center for Clinical Research
    • Texas
      • DeSoto, Texas, Forenede Stater, 75115
        • Rekruttering
        • Epic Medical Research - DeSoto
      • Edinburg, Texas, Forenede Stater, 78539
        • Rekruttering
        • South Texas Research Institute
      • Houston, Texas, Forenede Stater, 77043
        • Rekruttering
        • Biopharma Informatic, LLC
      • Houston, Texas, Forenede Stater, 77089
        • Rekruttering
        • Research Physicians Network, LLC
      • McKinney, Texas, Forenede Stater, 75071
        • Rekruttering
        • Texas Institute Of Cardiology
      • North Richland Hills, Texas, Forenede Stater, 76180
        • Rekruttering
        • North Hills Medical Research
      • San Antonio, Texas, Forenede Stater, 78230
        • Rekruttering
        • VIP Trials
      • Tomball, Texas, Forenede Stater, 77375
        • Rekruttering
        • Northwest Houston Heart Center
    • Washington
      • Redmond, Washington, Forenede Stater, 98052
        • Rekruttering
        • Eastside Research Associates Health Research
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Rekruttering
        • Puerto Rico Medical Research Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Body Mass Index (BMI) ≥ 25 at screening.
  • Weight loss of ≥ 10% on weekly GLP-1 RA.
  • Stable body weight.
  • Stable dose of GLP-1RA.
  • Stable gastrointestinal (GI) tolerability.
  • Contraception for females.
  • Willingness to follow trial procedures for the duration of the trial.

Exclusion Criteria:

  • Obesity induced by other endocrine disorders (ex: Cushing's syndrome).
  • Previous or planned surgical, endoscopic or device-based treatment for obesity.
  • History of malignancy.
  • Type 1/Type 2 diabetes mellitus (DM).
  • Family or personal history of medullary thyroid cancer.
  • Previous participation in a Maridebart Cafraglutide trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MariTide Arm 1
Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
Medicin: Maridebart Cafraglutide
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Andre navne:
  • AMG 133
Eksperimentel: MariTide Arm 2
Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
Medicin: Maridebart Cafraglutide
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Andre navne:
  • AMG 133

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percent Change from Baseline in Body Weight at Week 68
Tidsramme: Week 68
Week 68

Sekundære resultatmål

Resultatmål
Tidsramme
Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68
Tidsramme: Week 68
Week 68
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Tidsramme: Week 68
Week 68
Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Tidsramme: Week 68
Week 68
Plasma Concentration of Maridebart Cafraglutide at Week 68
Tidsramme: Week 68
Week 68
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Tidsramme: Up to 84 weeks
Up to 84 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. maj 2026

Primær færdiggørelse (Anslået)

3. januar 2028

Studieafslutning (Anslået)

28. februar 2028

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20250036

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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 trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) 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 trial.

IPD-delingsadgangskriterier

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fedme eller overvægt

Kliniske forsøg med Maridebart Cafraglutide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Liberia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner