A Phase 2 interventional study of Olatorepatide and Placebo in Overweight or Obesity, sponsored by Regeneron Pharmaceuticals. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity.
The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes.
The study is looking at:
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 120 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Drug: Olatorepatide · Drug: Placebo
Drug: Olatorepatide · Drug: Placebo
Administered per the protocol
Also known as: HS-20094
Administered per the protocol
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 30 weeks
Severity of TEAEs
Time frame: Up to approximately 30 weeks
Maximum plasma Concentration (Cmax)
Time frame: At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
Time frame: At week 15 and week 24
Percent change in body weight
Time frame: From baseline to week 25
Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)
Time frame: From baseline to weeks 7, 15 and 24
Change in in-clinic SBP
Time frame: From baseline to weeks 7, 15 and 24
Lowest concentration in a dosing interval (Ctrough)
Time frame: Up to approximately 30 weeks
Time to Cmax (Tmax)
Time frame: Up to approximately 30 weeks
Apparent Volume of distribution (Vd/F)
Time frame: Up to approximately 30 weeks
Apparent clearance (CL/F)
Time frame: Up to approximately 30 weeks
Apparent terminal half-life (t½)
Time frame: Up to approximately 30 weeks
Olatorepatide concentrations
Time frame: Up to approximately 30 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Time frame: Up to approximately 30 weeks
Magnitude of ADA to olatorepatide
Time frame: Up to approximately 30 weeks
Corrected QT interval using the Fridericia formula (QTcF)
Time frame: Pre-dose to up to 48 hours post-dose
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals