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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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Flourish Research, Ravenswood Rheumatology
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ChicagoUnited StatesRecruiting
Charter Research LLC - Chicago
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ChicagoUnited StatesRecruiting
Alliance for Multispecialty Research (AMR) Clinical Miami
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DoralUnited StatesRecruiting
AMR Clinical - Fort Myers
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Fort MyersUnited StatesRecruiting
Tribe Clinical Research
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GreenvilleUnited StatesRecruiting
AGA Clinical Trials
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HialeahUnited StatesRecruiting
Flourish Research, Nature Coast Clinical Research
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InvernessUnited StatesRecruiting
Flourish Research, Jacksonville Center for Clinical Research
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JacksonvilleUnited StatesRecruiting
AMR Clinical - Lexington
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LexingtonUnited StatesRecruiting
K2 Medical Research Maitland LLC, Main Office
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MaitlandUnited StatesRecruiting
AMR Clinical - Mobile
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MobileUnited StatesRecruiting
NYC Research Inc.
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New YorkUnited StatesRecruiting
AMR Clinical - Chicago Oak Brook
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Oak BrookUnited StatesRecruiting
Velocity Clinical Research - Omaha
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OmahaUnited StatesRecruiting
Rochester Clinical Research
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RochesterUnited StatesRecruiting
The IMA Group, IMA Clinical Research St. Petersburg
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St. PetersburgUnited StatesRecruiting
Charter Research LLC - The Villages
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The VillagesUnited StatesRecruiting
Diablo Clinical Research - Flourish Research
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Walnut CreekUnited StatesRecruiting
Chase Medical Research
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WaterburyUnited StatesRecruiting
AMR Clinical Wichita
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WichitaUnited StatesRecruiting
Clinical Site Partners, LLC dba Flourish Research
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Winter ParkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.