Study S001668

A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity

ClinicalTrials.gov record

Registration

Registration: NCT07523711
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 49
Start: 2026-04-09
Primary completion: 2026-11-18
Lead sponsor: Amgen
Conditions: Overweight; Obesity
Interventions: DRUG:COC; DRUG:Maridebart Cafraglutide
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Maximum Observed Concentration (Cmax) of COC [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 [Day 1 up to Day 89]
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC [Day 1 up to Day 89]

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