Tests olatorepatide in adults with overweight or obesity but without diabetes
Tests the experimental drug olatorepatide against placebo in adults with overweight or obesity.
Plain-language title generated from the registry record
Registry title: Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Key facts
- Where
- Chicago, Doral, Fort Myers, Greenville, Hialeah, Inverness, Jacksonville, Lexington, Maitland, Mobile, New York, Oak Brook, Omaha, Rochester, St. Petersburg, The Villages, Walnut Creek, Waterbury, Wichita, and Winter Park, United StatesSee the 21 sites
- Phase
- Phase 2
Where in United States
- Charter Research LLC - ChicagoChicago, United StatesTaking people
- Flourish Research, Ravenswood RheumatologyChicago, United StatesTaking people
- Alliance for Multispecialty Research (AMR) Clinical MiamiDoral, United StatesTaking people
- AMR Clinical - Fort MyersFort Myers, United StatesTaking people
- Tribe Clinical ResearchGreenville, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesTaking people
- Flourish Research, Nature Coast Clinical ResearchInverness, United StatesTaking people
- Flourish Research, Jacksonville Center for Clinical ResearchJacksonville, United StatesTaking people
- AMR Clinical - LexingtonLexington, United StatesTaking people
- K2 Medical Research Maitland LLC, Main OfficeMaitland, United StatesTaking people
- AMR Clinical - MobileMobile, United StatesTaking people
- NYC Research Inc.New York, United StatesTaking people
- AMR Clinical - Chicago Oak BrookOak Brook, United StatesTaking people
- Velocity Clinical Research - OmahaOmaha, United StatesTaking people
- Rochester Clinical ResearchRochester, United StatesTaking people
- The IMA Group, IMA Clinical Research St. PetersburgSt. Petersburg, United StatesTaking people
- Charter Research LLC - The VillagesThe Villages, United StatesTaking people
- Diablo Clinical Research - Flourish ResearchWalnut Creek, United StatesTaking people
- Chase Medical ResearchWaterbury, United StatesTaking people
- AMR Clinical WichitaWichita, United StatesTaking people
- Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07685808
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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; Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply.