Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Bo… (NCT07523711) | Clinical Trial Compass
RecruitingPhase 1
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
United States45 participantsStarted 2026-04-09
Plain-language 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.
Who can participate
Age range45 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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 to 35.0 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.
✓. Other inclusion criteria may apply.
Exclusion criteria
✕. 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.
✕. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.
✕. LDL cholesterol greater than 159 mg/dL.
What they're measuring
1
Maximum Observed Concentration (Cmax) of COC
Timeframe: Day 1 up to Day 89
2
Area Under the Concentration-time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of COC
Timeframe: Day 1 up to Day 89
3
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC