Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Part of paid clinical trials in Northridge, California.

Sponsor
Amgen
Study ID
NCT07225686
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Maridebart cafraglutide — DRUG
    Participants will receive maridebart cafraglutide as SC injections.
  • Placebo — DRUG
    Participants will receive placebo SC.

Study Details

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Key Dates

Start date
Dec 19, 2025
Status verified
May 2026
Primary completion
Sep 29, 2027
Completion
Sep 13, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide subcutaneously (SC).
  • Placebo Comparator: Placebo
    Participants will receive placebo SC.

Primary Outcome Measure

Change in AHI from baseline at week 52 [ Time Frame: At Week 52 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Valley Clinical TrialsNorthridgeCalifornia91325-
Peninsula Research AssociatesRolling Hills EstatesCalifornia90274-
Teradan Clinical TrialsBrandonFlorida33511-
Destiny Research CenterPalmetto BayFlorida33157-
Clinical Research Center Of FloridaPompano BeachFlorida33060-
NeuroTrials ResearchAtlantaGeorgia30328-
Basil ClinicalLaureltonNew York11413-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
CTI Clinical Research CenterCincinnatiOhio45212-
FutureSearch Trials of NeurologyAustinTexas78731-
Epic Medical Research - DeSotoDeSotoTexas75115-
Sleep Therapy & Research CenterSan AntonioTexas78229-
Northwest Clinical Research CenterBellevueWashington98007-

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By research site
Valley Clinical Trials· Northridge, CAPeninsula Research Associates· Rolling Hills Estates, CATeradan Clinical Trials· Brandon, FLDestiny Research Center· Palmetto Bay, FLClinical Research Center Of Florida· Pompano Beach, FLNeuroTrials Research· Atlanta, GA

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