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.
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.
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.
Single group
COC
DrugAdministered orally.
Maridebart Cafraglutide
DrugAdministered as SC injection.
Maximum Observed Concentration (Cmax) of COC
Area Under the Concentration-time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of COC
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC
Plasma Concentrations of Maridebart Cafraglutide
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies
