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

NCT07685808 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HS-20094-OB-25106
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Overweight or Obesity

Keywords

Body weight; Glucagon-Like Peptide-1 (GLP-1)/Gastric inhibitory polypeptide (GIP) receptor agonist; Dose-finding; Control appetite

Outcome Measures

Primary Outcomes (3)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 60 weeks

• Severity of TEAEs

  Up to approximately 60 weeks

• Percent change in body weight

  From baseline to week 52

Secondary Outcomes (3)

• Olatorepatide concentrations

  Up to approximately 60 weeks

• Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

  Up to approximately 52 weeks

• Magnitude of ADA to olatorepatide

  Up to approximately 52 weeks

Study Arms (6)

Olatorepatide arm 1

EXPERIMENTAL

Drug: Olatorepatide

Olatorepatide arm 2

EXPERIMENTAL

Drug: Olatorepatide

Olatorepatide arm 3

EXPERIMENTAL

Drug: Olatorepatide

Olatorepatide arm 4

EXPERIMENTAL

Drug: Olatorepatide

Olatorepatide arm 5

EXPERIMENTAL

Drug: Olatorepatide

Matching Placebo arm 6

ACTIVE COMPARATOR

Drug: Placebo

Interventions

Olatorepatide DRUG

Administered per the protocol

Also known as: HS-20094

Olatorepatide arm 1; Olatorepatide arm 2; Olatorepatide arm 3; Olatorepatide arm 4; Olatorepatide arm 5

Placebo DRUG

Administered per the protocol

Matching Placebo arm 6

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

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: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): January 21, 2028
• Study Completion (Estimated): January 21, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-05

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