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

Sponsor ID
20230161
Clinicaltrials.gov ID
NCT07523711
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 133
Type
Interventional
Masking
None (Open Label)
Enrollment
49
Additional Study Details

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
Status
Contact Us
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