Recruitment Complete
Sponsor ID
20230161
Effect of Maridebart Cafraglutide on How Oral Contraceptives are Absorbed and Processed in the Body in Postmenopausal Female Participants Living with Overweight or Obesity
Study Details
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.
Protocol Summary
Primary Outcome Measures
Maximum Observed Concentration (Cmax) of COC
Timeframe: Day 1 up to Day 89
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
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC
Timeframe: Day 1 up to Day 89
Secondary Outcome Measures
Plasma Concentrations of Maridebart Cafraglutide
Timeframe: Up to Day 142
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 to end of trial (approximately 142 days)
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From screening (Day -28) up to end of trial (approximately 170 days)
Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies
Timeframe: Up to Day 142
Locations
Location
Fortrea Clinical Research Unit Inc. - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting
Location
Fortrea Clinical Research Unit - Dallas
Dallas, TX, United States, 75247-4968
Status
Recruiting