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

NCT07685808
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
360
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-07-28
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Number of sites
5
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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
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Short title
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
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Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-01-21
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First posted
2026-07-06
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Registry last updated
2026-08-20
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Primary completion date
2028-01-21
clinicaltrials.gov
Start date
2026-07-28
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Participants
360
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Participant count basis
Estimated
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Planned participants
360
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Protocol amendments
0
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Number of sites
5
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07685808
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ClinicalTrials.gov ID
NCT07685808
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Up to approximately 60 weeks

  2. Severity of TEAEs

    Timeframe: Up to approximately 60 weeks

  3. Percent change in body weight

    Timeframe: From baseline to week 52

  1. Olatorepatide concentrations

    Timeframe: Up to approximately 60 weeks

  2. Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

    Timeframe: Up to approximately 52 weeks

  3. Magnitude of ADA to olatorepatide

    Timeframe: Up to approximately 52 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

  • Diablo Clinical Research - Flourish ResearchWalnut Creek, United StatesRecruiting
  • K2 Medical Research Maitland LLC, Main OfficeMaitland, United StatesRecruiting
  • Charter Research LLC - The VillagesThe Villages, United StatesRecruiting
  • Clinical Site Partners, LLC DBA Flourish ResearchWinter Park, United StatesRecruiting
  • AMR Clinical - LexingtonLexington, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)