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Olatorepatide

Phase 2

Overweight or Obesity | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 29, 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
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07431086Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the USPHASE2 RECRUITING 120 — — Mar 16, 2026Dec 28, 2026Apr 29, 20263 United States
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Study Endpoints
Primary Endpoints
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 30 weeks
Severity of TEAEs
Up to approximately 30 weeks
Maximum plasma Concentration (Cmax)
At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
At week 15 and week 24
Secondary Endpoints
Percent change in body weight
From baseline to week 25
Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)
From baseline to weeks 7, 15 and 24
Change in in-clinic SBP
From baseline to weeks 7, 15 and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
General CohortEXPERIMENTAL -
Subgroup CohortEXPERIMENTAL -
Interventions
NameTypeDescription
OlatorepatideDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1. Body mass index ≥27.0 kg/m\^2 to \<45.0 kg/m\^2 at screening 2. Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment Key Excl...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07431086Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07431086studyFirstPostDate: changed