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

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

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

Study Overview

• Status: Recruiting
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: Placebo; Drug: Olatorepatide

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Clinical Research - Flourish Research
  • Florida
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Clinical Site Partners, LLC dba Flourish Research
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Flourish Research - San Antonio Medical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General Cohort	Drug: Placebo; Administered per the protocol; Drug: Olatorepatide; Administered per the protocol; Other Names: HS-20094
Experimental: Subgroup Cohort	Drug: Placebo; Administered per the protocol; Drug: Olatorepatide; Administered per the protocol; Other Names: HS-20094

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)	Up to approximately 30 weeks
Severity of TEAEs	Up to approximately 30 weeks
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)	At week 15 and week 24
Maximum plasma Concentration (Cmax)	At week 15 and week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change in body weight	From baseline to week 25
Lowest concentration in a dosing interval (Ctrough)	Up to approximately 30 weeks
Time to Cmax (Tmax)	Up to approximately 30 weeks
Apparent Volume of distribution (Vd/F)	Up to approximately 30 weeks
Apparent clearance (CL/F)	Up to approximately 30 weeks
Apparent terminal half-life (t½)	Up to approximately 30 weeks
Olatorepatide concentrations	Up to approximately 30 weeks
Occurrence of Anti-Drug Antibody (ADA) to olatorepatide	Up to approximately 30 weeks
Magnitude of ADA to olatorepatide	Up to approximately 30 weeks
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
Corrected QT interval using the Fridericia formula (QTcF)	Pre-dose to up to 48 hours post-dose

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 28, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Body weight; Waist circumference; Glucose-dependent Insulinotropic Polypeptide (GIP); Glucagon-Like Peptide-1 (GLP-1) receptor agonist; Control appetite
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Body Weight
• Other Study ID Numbers: HS-20094-OB-2569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing 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

• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No