A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity
Amgen
Summary
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.
Eligibility
- Age range
- 45–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria 1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria. 2. Body mass index must be 25.0 to 35.0 kg/m². 3. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening. 4. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening. 5. Other inclusion criteria may apply. Exclusion Criteria 1. History or evidence of any clinically significant medical condition, abnorm…
Interventions
- DrugCOC
Administered orally.
- DrugMaridebart Cafraglutide
Administered as SC injection.
Locations (3)
- Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, Florida
- Fortrea Clinical Research Unit - DallasDallas, Texas
- Fortrea Clinical Research Unit Inc. - MadisonMadison, Wisconsin