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COC

Phase 1

Overweight | Small molecule | Metabolic |Amgen Inc.|Last Updated: Apr 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07523711Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or ObesityPHASE1 RECRUITING 45 — — Apr 9, 2026Oct 7, 2026Apr 27, 20263 United States
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Study Endpoints
Primary Endpoints
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
Secondary Endpoints
Plasma Concentrations of Maridebart Cafraglutide
Up to Day 142
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 to end of trial (approximately 142 days)
Number of Participants with Serious Adverse Events (SAEs)
From screening (Day -28) up to end of trial (approximately 170 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
COC + Maridebart CafraglutideEXPERIMENTALParticipants will receive COC orally and maridebart cafraglutide subcutaneously (SC).
Interventions
NameTypeDescription
COCDRUGAdministered orally.
Maridebart CafraglutideDRUGAdministered as SC injection.
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Eligibility Criteria
Age Range45 Years — 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria 1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria. 2. Body mass index must be 25.0 to 35.0 kg/m². 3. Body weight must be stable, with less than 5 kg self-reported change in the 3 mo...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07523711primaryCompletionDate: changed
LOWMay 24, 2026NCT07523711studyFirstPostDate: changed
LOWMay 21, 2026NCT07523711NEW_TRIAL: changed
LOWMay 21, 2026NCT07523711NEW_TRIAL: changed