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)
26. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
300
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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Alabama
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Pelham, Alabama, Forente stater, 35124
- Rekruttering
- Cahaba Research, Inc.
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Arizona Clinical Trials
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Sun City, Arizona, Forente stater, 85351
- Rekruttering
- Epic Medical Research - Sun City
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California
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Palm Springs, California, Forente stater, 92262
- Rekruttering
- Desert Oasis Healthcare Medical Group
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Rialto, California, Forente stater, 92377
- Rekruttering
- Inland Empire Liver Foundation
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Rolling Hills Estates, California, Forente stater, 90274
- Rekruttering
- Peninsula Research Associates
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San Diego, California, Forente stater, 92120
- Rekruttering
- Apex Clinical Research
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Santa Ana, California, Forente stater, 92701
- Rekruttering
- Southern California Clinical Research
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Florida
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Gainesville, Florida, Forente stater, 32610
- Rekruttering
- University of Florida Department of Medicine
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Hialeah, Florida, Forente stater, 33012
- Rekruttering
- AGA Clinical Trials
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Margate, Florida, Forente stater, 33063
- Rekruttering
- South Florida Clinical Research
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Miami, Florida, Forente stater, 33165
- Rekruttering
- New Horizon Research Center
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Miami, Florida, Forente stater, 33173
- Rekruttering
- Research Institute of South Florida
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Orlando, Florida, Forente stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions
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Orlando, Florida, Forente stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Port Orange, Florida, Forente stater, 32127
- Rekruttering
- Progressive Medical Research
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The Villages, Florida, Forente stater, 32162
- Rekruttering
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, Forente stater, 30024
- Rekruttering
- NSC Research
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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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Woodstock, Georgia, Forente stater, 30189
- Rekruttering
- North Georgia Clinical 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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Skokie, Illinois, Forente stater, 60077
- Rekruttering
- Endeavor Health
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Rekruttering
- Pennington Biomedical Research Center
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Michigan
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Troy, Michigan, Forente stater, 48098
- Rekruttering
- Arcturus Healthcare, Public Limited Company, Troy Internal Medicine Research Division
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Mississippi
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Ridgeland, Mississippi, Forente stater, 39157
- Rekruttering
- Sky Integrative Medical Center
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Montana
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Missoula, Montana, Forente stater, 59808
- Rekruttering
- Montana Medical Research
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Rekruttering
- Excel Clinical Research
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New York
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New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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Rochester, New York, Forente stater, 14609
- Rekruttering
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, Forente stater, 28557
- Rekruttering
- Centricity Research Morehead City Specialty
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Raleigh, North Carolina, Forente stater, 27609
- Rekruttering
- Accellacare of Raleigh
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Wilmington, North Carolina, Forente stater, 28401
- Rekruttering
- Accellacare Research of Wilmington
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Oklahoma
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Chickasha, Oklahoma, Forente stater, 73018
- Rekruttering
- Epic Medical Research - Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
- Rekruttering
- Lynn Health Science Institute
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Pennsylvania
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Duncansville, Pennsylvania, Forente stater, 16635
- Rekruttering
- Altoona Center for Clinical Research
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Texas
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DeSoto, Texas, Forente stater, 75115
- Rekruttering
- Epic Medical Research - DeSoto
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Edinburg, Texas, Forente stater, 78539
- Rekruttering
- South Texas Research Institute
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Houston, Texas, Forente stater, 77043
- Rekruttering
- Biopharma Informatic, LLC
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Houston, Texas, Forente stater, 77089
- Rekruttering
- Research Physicians Network, LLC
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McKinney, Texas, Forente stater, 75071
- Rekruttering
- Texas Institute of Cardiology
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North Richland Hills, Texas, Forente stater, 76180
- Rekruttering
- North Hills Medical Research
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San Antonio, Texas, Forente stater, 78230
- Rekruttering
- VIP Trials
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Tomball, Texas, Forente stater, 77375
- Rekruttering
- Northwest Houston Heart Center
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Washington
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Redmond, Washington, Forente stater, 98052
- Rekruttering
- Eastside Research Associates Health Research
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Ponce, Puerto Rico, 00717
- Rekruttering
- Puerto Rico Medical Research Inc.
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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:
- 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
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: MariTide Arm 1
Participants will receive maridebart cafraglutide dosing schedule 1 during the treatment period.
|
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Andre navn:
|
|
Eksperimentell: MariTide Arm 2
Participants will receive maridebart cafraglutide dosing schedule 2 during the treatment period.
|
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Andre navn:
|
Hva måler studien?
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
|
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Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Tidsramme: Week 68
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Week 68
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Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68
Tidsramme: Week 68
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Week 68
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Plasma Concentration of Maridebart Cafraglutide at Week 68
Tidsramme: Week 68
|
Week 68
|
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Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Tidsramme: Up to 84 weeks
|
Up to 84 weeks
|
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)
11. mai 2026
Primær fullføring (Antatt)
3. januar 2028
Studiet fullført (Antatt)
28. februar 2028
Datoer for studieregistrering
Først innsendt
4. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20250036
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 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.
Tilgangskriterier for IPD-deling
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 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. .