Olatorepatide for Obesity

Not currently recruiting at 2 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, olatorepatide, to determine its safety and effectiveness for treating individuals who are overweight or obese without diabetes. Researchers aim to identify any side effects, assess the drug's efficacy, and understand how the body processes it. They also seek to determine if the body produces antibodies against the drug, which might reduce its effectiveness. The trial is suitable for individuals with a body mass index (BMI) between 27 and 45 who have not experienced diabetes or significant weight changes recently. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that olatorepatide is likely to be safe for humans?

Previous studies have shown that olatorepatide is safe for people with diabetes. Research indicates that stomach issues are the most common side effects, occurring more frequently at higher doses. Although rare, some serious side effects have been reported, but they remain uncommon. This treatment is still under investigation, and further information will enhance understanding of its safety.12345

Why do researchers think this study treatment might be promising for obesity?

Olatorepatide is unique because it offers a new approach to treating obesity by potentially targeting specific pathways in the body that regulate appetite and metabolism. Unlike the standard treatments for obesity, which often include lifestyle changes or medications like orlistat and phentermine that focus on reducing fat absorption or suppressing appetite, Olatorepatide may work on a deeper biological level. Researchers are excited about this treatment because it could offer a more effective and long-lasting solution for weight management by directly influencing the body’s energy balance mechanisms.

What evidence suggests that olatorepatide might be an effective treatment for obesity?

Research has shown that olatorepatide can be effective for weight loss. In earlier studies, participants who took olatorepatide lost up to 19% of their body weight over 48 weeks. This significant weight loss indicates a meaningful change for many participants. The drug helps control appetite and metabolism. These findings suggest that olatorepatide could be a promising option for those struggling with obesity. Participants in this trial will join either the General Cohort or the Subgroup Cohort, both receiving olatorepatide as part of the study.24678

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults in the US who are overweight or obese (BMI between 27 and 45), do not have diabetes, and can follow study instructions. People with recent major weight changes, past or planned weight loss surgery, certain pancreas or gallbladder problems, or a history of cancer within the last 5 years cannot join.

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.
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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

Trial Overview

The study compares olatorepatide (a new drug) to a placebo to see how safe it is, how well it works for people with overweight or obesity without diabetes, and how the body processes the drug. Participants are randomly assigned to receive either olatorepatide or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Subgroup CohortExperimental Treatment2 Interventions
Group II: General CohortExperimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

Regeneron's obesity drug shows Zepbound-like efficacy in ...

At Week 48, Hansoh reported mean weight loss of up to 19.3% in the olatorepatide cohorts. The result supports the claim the drug candidate has ...

Olatorepatide Obesity Treatment Licensed by Regeneron ...

Patients treated with olatorepatide achieved up to 19% body-weight loss at week 48. Regeneron's global Phase 3 registrational program to be initiated later ...

Regeneron's Olatorepatide Hits 19% Mean Weight Loss in ...

Breaking News: Regeneron says its in-licensed dual GLP-1/GIP agonist hit up to 19% mean weight loss in a Phase 3 obesity trial Bottom line: ...

Olatorepatide (HS-20094) Achieves Up to 19.3% Weight ...

Olatorepatide achieved up to 19.3% body-weight loss at Week 48, with a high proportion of participants achieving clinically meaningful weight-loss.

Regeneron touts Chinese Phase III data for obesity hopeful ...

The weight-loss candidate also had lower treatment discontinuation rates compared with published Phase III data for other incretin drugs. Go ...

Olatorepatide Obesity Treatment Licensed by ...

Patients treated with olatorepatide achieved up to 19% body-weight loss at week 48. Regeneron's global Phase 3 registrational program to be initiated later ...

olatorepatide (HS-20094) / Jiangsu Hansoh Pharma, ...

Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US ... Research data show that in diabetic patients, HS-20094 is safe and ...

Olatorepatide for Obesity

This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this ...