NCT07685808From ClinicalTrials.govRecruiting

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

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

Overweight or Obesity

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Regeneron Pharmaceuticals
Enrolment target: 360
Started: 28 July 2026
Main results due: 21 January 2028
Study sites: 18
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(18)

AMR Clinical - Mobile
Mobile, Alabama, United States
Recruiting
Diablo Clinical Research - Flourish Research
Walnut Creek, California, United States
Recruiting
AMR Clinical - Miami
Doral, Florida, United States
Recruiting
AMR Clinical - Fort Myers
Fort Myers, Florida, United States
Recruiting
AGA Clinical Trials
Hialeah, Florida, United States
Recruiting
Flourish Research, Nature Coast Clinical Research
Inverness, Florida, United States
Recruiting
Flourish Research, Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Recruiting
K2 Medical Research Maitland LLC, Main Office
Maitland, Florida, United States
Recruiting
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, United States
Recruiting
Charter Research LLC - The Villages
The Villages, Florida, United States
Recruiting
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida, United States
Recruiting
Charter Research LLC - Chicago
Chicago, Illinois, United States
Recruiting
Flourish Research - Chicago
Chicago, Illinois, United States
Recruiting
AMR Clinical - Chicago Oak Brook
Oak Brook, Illinois, United States
Recruiting
AMR Clinical - Wichita
Wichita, Kansas, United States
Recruiting
AMR Clinical - Lexington
Lexington, Kentucky, United States
Recruiting
Rochester Clinical Research
Rochester, New York, United States
Recruiting
Tribe Clinical Research
Greenville, South Carolina, United States
Recruiting

Showing 18 of 18 sites. 18 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07685808. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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