Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT07523711
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • COC — DRUG
    Administered orally.
  • Maridebart Cafraglutide — DRUG
    Administered as SC injection.

Study Details

The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.

Key Dates

Start date
Apr 9, 2026
Status verified
Apr 2026
Primary completion
Oct 7, 2026
Completion
Oct 7, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: COC + Maridebart Cafraglutide
    Participants will receive COC orally and maridebart cafraglutide subcutaneously (SC).

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of COC [ Time Frame: Day 1 up to Day 89 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit - Daytona BeachDaytona BeachFlorida32117-5116-
Fortrea Clinical Research Unit - DallasDallasTexas75247-4968-
Fortrea Clinical Research Unit Inc. - MadisonMadisonWisconsin53704-2526-

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