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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorAmgen

About this trial

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 criteria

Qualifiers

Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.

Body mass index must be ≥ 25.0 and ≤ 38.0 kg/m².

Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.

Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.

Disqualifiers

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.

History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.

Endocrine disorders that can cause obesity, such as Cushing's syndrome.

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.

Trial design

Treatments tested in this trial

  • COC
  • Maridebart Cafraglutide

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators