NCT07685808RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 28 Jul 2026
- Primary completion date
- 21 Jan 2028
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Obesity
- NCT number
- NCT07685808
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 360
- From 28 Jul 2026 to the primary completion date, 21 Jan 2028
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flourish Research, Ravenswood Rheumatology Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Charter Research LLC - Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Alliance for Multispecialty Research (AMR) Clinical Miami Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| AMR Clinical - Fort Myers Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Tribe Clinical Research Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| AGA Clinical Trials Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
| Flourish Research, Nature Coast Clinical Research Coordinator of this site? Confirm its status | Inverness | United States | Recruiting |
| Flourish Research, Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| AMR Clinical - Lexington Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| K2 Medical Research Maitland LLC, Main Office Coordinator of this site? Confirm its status | Maitland | United States | Recruiting |
| AMR Clinical - Mobile Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| NYC Research Inc. Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| AMR Clinical - Chicago Oak Brook Coordinator of this site? Confirm its status | Oak Brook | United States | Recruiting |
| Velocity Clinical Research - Omaha Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Rochester Clinical Research Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| The IMA Group, IMA Clinical Research St. Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Charter Research LLC - The Villages Coordinator of this site? Confirm its status | The Villages | United States | Recruiting |
| Diablo Clinical Research - Flourish Research Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Chase Medical Research Coordinator of this site? Confirm its status | Waterbury | United States | Recruiting |
| AMR Clinical Wichita Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| Clinical Site Partners, LLC dba Flourish Research Coordinator of this site? Confirm its status | Winter Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.