> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-olatorepatide-in-adult-participants-living-with-17e84dcf-c66e-4dfe-9a94-b8cf5e308054 > Record changed: 2026-10-13 # Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes NCT07685808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Participants 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Start date 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Short title** Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Dates **Completion date** 2028-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **First posted** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Primary completion date** 2028-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Start date** 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Size and sites **Participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Planned participants** 360 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Identifiers **Registry ID** NCT07685808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **ClinicalTrials.gov ID** NCT07685808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07685808) ## Related records ### Drugs (1) - [Olatorepatide](https://trialight.com/data/asset/olatorepatide-27aace75-7f36-423e-b10f-55af9d93f3b0.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. 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