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Active, Not Recruiting

NCT Number: NCT07431086

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diablo Clinical Research - Flourish Research, Walnut Creek, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening
  • 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:

  • History of Type 1 or Type 2 diabetes
  • Change in body weight >5 kg within approximately 3 months before screening as described in the protocol
  • Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period
  • 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

Treatment and study plan

Olatorepatide

Drug

Administered per the protocol

Other names: HS-20094

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 30 weeks

  2. Severity of TEAEs

    Time frame: Up to approximately 30 weeks

  3. Maximum plasma Concentration (Cmax)

    Time frame: At week 15 and week 24

  4. Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)

    Time frame: At week 15 and week 24

Secondary outcomes

  1. Percent change in body weight

    Time frame: From baseline to week 25

  2. Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP)

    Time frame: From baseline to weeks 7, 15 and 24

  3. Change in in-clinic SBP

    Time frame: From baseline to weeks 7, 15 and 24

  4. Lowest concentration in a dosing interval (Ctrough)

    Time frame: Up to approximately 30 weeks

  5. Time to Cmax (Tmax)

    Time frame: Up to approximately 30 weeks

  6. Apparent Volume of distribution (Vd/F)

    Time frame: Up to approximately 30 weeks

  7. Apparent clearance (CL/F)

    Time frame: Up to approximately 30 weeks

  8. Apparent terminal half-life (t½)

    Time frame: Up to approximately 30 weeks

  9. Olatorepatide concentrations

    Time frame: Up to approximately 30 weeks

  10. Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

    Time frame: Up to approximately 30 weeks

  11. Magnitude of ADA to olatorepatide

    Time frame: Up to approximately 30 weeks

  12. Corrected QT interval using the Fridericia formula (QTcF)

    Time frame: Pre-dose to up to 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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