A Phase 2 interventional study of Olatorepatide and Placebo in Overweight or Obesity, sponsored by Regeneron Pharmaceuticals. Recruiting at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.
The study is looking at:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 360 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Olatorepatide
Drug: Olatorepatide
Drug: Olatorepatide
Drug: Olatorepatide
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 60 weeks
Severity of TEAEs
Time frame: Up to approximately 60 weeks
Percent change in body weight
Time frame: From baseline to week 52
Olatorepatide concentrations
Time frame: Up to approximately 60 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide
Time frame: Up to approximately 52 weeks
Magnitude of ADA to olatorepatide
Time frame: Up to approximately 52 weeks
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
Started Jul 2026 (actual). Primary completion is estimated for Jan 2028, 17 months after the start.
Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 17 months is above that.
Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Olatorepatide