NCT07685808 · Regeneron Pharmaceuticals
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Olatorepatide
Administered per the protocol
DRUG
Placebo
Administered per the protocol
Primary outcome measures
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 60 weeks
Severity of TEAEs
Time frame: Up to approximately 60 weeks
Percent change in body weight
Time frame: From baseline to week 52
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Key
Exclusion criteria
- 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
Where
- Walnut Creek, California
- Maitland, Florida
- The Villages, Florida
- Winter Park, Florida
- Lexington, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations