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Clinical Trials in the USA / NCT07431086
Active, not recruiting Phase 2

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US

NCT07431086 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2026-03-16
Last updated
2026-06-17

Condition(s) studied

Overweight or Obesity

Investigational drug(s) / intervention(s)

Olatorepatide →Placebo

Olatorepatide: Administered per the protocol

Placebo: Administered per the protocol

Study summary

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:

* What side effects the study drug might cause
* How much the study drug is in the blood at different times
* How well the study drug works
* If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 Exclusion Criteria: 1. History of Type 1 or Type 2 diabetes 2. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol 3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period 4. History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Diablo Clinical Research - Flourish Research Walnut Creek California
Clinical Site Partners, LLC DBA Flourish Research Winter Park Florida
Flourish Research - San Antonio Medical Trials San Antonio Texas

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Other trials for the same condition

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity Active, not recruiting
Berries, Inflammation, and Gut Microbiome Active, not recruiting
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities Active, not recruiting
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women Active, not recruiting
Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07431086 on ClinicalTrials.gov ↗ ← All trials in the USA