RecruitingOverweightObesity
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Eligible age
45–65 yrs
Accepts
Women
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Amgen
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 1. History or evidence of any clinically significant medical condition, abnormal physical exam, ECG, vital sign, or laboratory finding that could increase risk or interfere with study participation.
- ✕ 2. History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.
- ✕ 3. Endocrine disorders that can cause obesity, such as Cushing's syndrome.
- ✕ 4. History of acute or chronic pancreatitis within 1 year before check-in, pancreatic enzyme elevations greater than 2 times the upper limit of normal, or fasting triglycerides greater than 300 mg/dL.
- ✕ 5. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.
- ✕ 6. LDL cholesterol greater than 159 mg/dL.
- ✕ 7. Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.
- ✕ 8. Malignancy within the past 5 years, except nonmelanoma skin cancer.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07523711 · last updated 2026-04-27