Study S002447

A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, Tolerability, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity in the US

ClinicalTrials.gov record

Registration

Registration: NCT07431086
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 120
Start: 2026-03-16
Primary completion: 2026-11-13
Lead sponsor: Regeneron Pharmaceuticals
Conditions: Overweight or Obesity
Interventions: DRUG:Olatorepatide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

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]

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