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NCT Number: NCT07685808

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes

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:

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

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Body Mass Index (BMI) ≥30.0 kg/m^2 to <45.0 kg/m^2 at screening OR
  • BMI ≥27.0 kg/m^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol

Key Exclusion Criteria:

  • Previous or current diagnosis of Type 1 or Type 2 diabetes at screening
  • 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 as described in the protocol
  • History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones
  • History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

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 60 weeks

  2. Severity of TEAEs

    Time frame: Up to approximately 60 weeks

  3. Percent change in body weight

    Time frame: From baseline to week 52

Secondary outcomes

  1. Olatorepatide concentrations

    Time frame: Up to approximately 60 weeks

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

    Time frame: Up to approximately 52 weeks

  3. Magnitude of ADA to olatorepatide

    Time frame: Up to approximately 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 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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