Olatorepatide for Obesity

Recruiting at 2 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Diabetes, Bariatric surgery, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity.

The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes.

The study is looking at:

* What side effects the study drug might cause

* How much the study drug is in the blood at different times

* How well the study drug works

* If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Body mass index ≥27.0 kg/m^2 to <45.0 kg/m^2 at screening

Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessments

Exclusion Criteria

I have had or plan to have weight loss surgery before or during the study.

My body weight has changed by more than 5 kg in the last 3 months.

I have had pancreatitis, gallbladder problems, or another recent or active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olatorepatide or placebo to assess safety, tolerability, and efficacy

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Olatorepatide

How Is the Trial Designed?

Group I: Subgroup Cohort Experimental Treatment 2 Interventions

Group II: General Cohort Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School