Recruiting
Phase 2

Olatorepatide

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07685808

Conditions

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Olatorepatide

Placebo

Study Details

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

Study ID

NCT07685808

Start date

Jul 28, 2026

Status verified date

Oct, 2026

Completion date

Jan 21, 2028

Anticipated

Primary completion date

Jan 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Body Mass Index (BMI) ≥30.0 kg/m\^2 to <45.0 kg/m\^2 at screening OR
2. 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:

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

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Olatorepatide arm 1

experimental: Olatorepatide arm 2

experimental: Olatorepatide arm 3

experimental: Olatorepatide arm 4

experimental: Olatorepatide arm 5

active comparator: Matching Placebo arm 6

Interventions

Olatorepatide

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 60 weeks ]
  • Severity of TEAEs [ Time Frame: Up to approximately 60 weeks ]
  • Percent change in body weight [ Time Frame: From baseline to week 52 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

AMR Clinical - Mobile

Recruiting

Mobile, Alabama, United States, 36608

Diablo Clinical Research - Flourish Research

Recruiting

Walnut Creek, California, United States, 94598

Chase Medical Research

Recruiting

Waterbury, Connecticut, United States, 06708

Alliance for Multispecialty Research (AMR) Clinical Miami

Recruiting

Doral, Florida, United States, 33172

AMR Clinical - Fort Myers

Recruiting

Fort Myers, Florida, United States, 33912

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Flourish Research, Nature Coast Clinical Research

Recruiting

Inverness, Florida, United States, 34452

Flourish Research, Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

K2 Medical Research Maitland LLC, Main Office

Recruiting

Maitland, Florida, United States, 32751

The IMA Group, IMA Clinical Research St. Petersburg

Recruiting

St. Petersburg, Florida, United States, 33704

Charter Research LLC - The Villages

Recruiting

The Villages, Florida, United States, 32162

Clinical Site Partners, LLC DBA Flourish Research

Recruiting

Winter Park, Florida, United States, 32789

Charter Research LLC - Chicago

Recruiting

Chicago, Illinois, United States, 60618

Flourish Research - Chicago

Recruiting

Chicago, Illinois, United States, 60625

AMR Clinical - Chicago Oak Brook

Recruiting

Oak Brook, Illinois, United States, 60523

AMR Clinical - Wichita

Recruiting

Wichita, Kansas, United States, 67207

AMR Clinical - Lexington

Recruiting

Lexington, Kentucky, United States, 40509

Velocity Clinical Research - Omaha

Recruiting

Omaha, Nebraska, United States, 68134

NYC Research Inc

Recruiting

New York, New York, United States, 10016

Rochester Clinical Research

Recruiting

Rochester, New York, United States, 14609

Tribe Clinical Research

Recruiting

Greenville, South Carolina, United States, 29607

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.