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

NCT07431086 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HS-20094-OB-2569
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Overweight or Obesity

Keywords

Body weight; Waist circumference; Glucagon-Like Peptide-1 (GLP-1) receptor agonist; Control appetite; Glucose-dependent Insulinotropic Polypeptide (GIP)

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (12)

• Percent change in body weight

  From baseline to week 25

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

  From baseline to weeks 7, 15 and 24

• Change in in-clinic SBP

  From baseline to weeks 7, 15 and 24

• Lowest concentration in a dosing interval (Ctrough)

  Up to approximately 30 weeks

• Time to Cmax (Tmax)

  Up to approximately 30 weeks

Study Arms (2)

General Cohort

EXPERIMENTAL

Drug: Olatorepatide; Drug: Placebo

Subgroup Cohort

EXPERIMENTAL

Drug: Olatorepatide; Drug: Placebo

Interventions

Olatorepatide DRUG

Administered per the protocol

Also known as: HS-20094

General Cohort; Subgroup Cohort

Placebo DRUG

Administered per the protocol

General Cohort; Subgroup Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Diablo Clinical Research - Flourish Research

Walnut Creek, California, 94598, United States

RECRUITING

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida, 32789, United States

RECRUITING

Flourish Research - San Antonio Medical Trials

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

US (3)