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 — DRUGAdministered orally.
- Maridebart Cafraglutide — DRUGAdministered 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 CafraglutideParticipants 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
- Amgen Call Center866-572-6436
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fortrea Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | 32117-5116 | - |
| Fortrea Clinical Research Unit - Dallas | Dallas | Texas | 75247-4968 | - |
| Fortrea Clinical Research Unit Inc. - Madison | Madison | Wisconsin | 53704-2526 | - |
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