360 Participants NeededMy employer runs this trial

Olatorepatide for Obesity

Recruiting at 24 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 individuals with obesity who do not have diabetes. Researchers aim to identify any side effects, understand the drug's impact on the body, and assess its processing within the body. Participants will join different groups to test various doses and schedules, with some receiving a placebo (a non-active substance). Suitable candidates have a BMI of 30 or higher, or a BMI of 27 or higher with conditions such as high blood pressure, high cholesterol, or sleep apnea. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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 trial coordinators or your doctor.

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

Research has shown that olatorepatide is still under study to assess its safety. Health authorities have not yet reviewed previous studies, so detailed safety information remains unavailable. However, the drug's progression to Phase 2 trials indicates some safety in earlier tests. These initial tests typically involve a small group of participants to evaluate safety and tolerability. So far, olatorepatide has not demonstrated major safety issues, but further testing is necessary to fully understand its safety profile.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about Olatorepatide because it offers a novel approach to tackling obesity. Unlike current treatments that often focus on appetite suppression or metabolism boosting, Olatorepatide works by a new mechanism that directly impacts fat cells, potentially leading to more effective weight loss. Additionally, this treatment might offer a better safety profile and fewer side effects compared to traditional options like phentermine or orlistat. This innovative approach could provide new hope for individuals struggling with obesity, offering a potentially more targeted and efficient solution.

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

Research has shown that olatorepatide might aid in weight loss. This drug is designed to influence the body's management of weight and appetite. Early studies suggest it could help individuals with obesity lose weight by altering how the body processes fat and energy. These studies also examine the drug's absorption and utilization in the body, which is crucial for understanding its long-term effects. Although specific data on olatorepatide's effectiveness in humans is still being collected, its mechanism offers a promising new approach for treating obesity. Participants in this trial will receive different dosages of olatorepatide or a placebo to evaluate its effects.678910

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 who are overweight or have obesity (BMI of at least 30, or BMI of at least 27 with conditions like high blood pressure, abnormal cholesterol, prediabetes, sleep apnea, heart disease, heart failure, or stroke). People with diabetes cannot join.

Inclusion Criteria

Body Mass Index (BMI) ≥30.0 kg/m^2 to <45.0 kg/m^2 at screening
BMI ≥27.0 kg/m^2 at screening with at least 1 weight-related co-morbidity: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, or established cerebrovascular disease

Exclusion Criteria

I have had pancreatitis, cholecystitis, or gallbladder stones with symptoms.
My body weight has changed by more than 5 kg in the last 3 months.
I have had bariatric surgery or procedures to change or remove it.
See 2 more

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, pharmacokinetics, 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 an experimental drug called olatorepatide to a placebo. Participants will receive different doses and schedules to see how safe the drug is and how well it works in people with overweight or obesity but without diabetes.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Olatorepatide arm 5Experimental Treatment1 Intervention
Group II: Olatorepatide arm 4Experimental Treatment1 Intervention
Group III: Olatorepatide arm 3Experimental Treatment1 Intervention
Group IV: Olatorepatide arm 2Experimental Treatment1 Intervention
Group V: Olatorepatide arm 1Experimental Treatment1 Intervention
Group VI: Matching Placebo arm 6Active Control1 Intervention

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

1.

outcomes.com

outcomes.com/

Outcomes | Healthcare Solutions for Pharmacy, Pharma, and ...

The Outcomes platform is the ideal solution for gaining insight across the entire treatment journey. Gain access to all the data you need to improve medication ...

2.

secure.outcomesmtm.com

secure.outcomesmtm.com/

OutcomesOne™ Platform

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40957960/

Macrovascular and microvascular outcomes of metabolic ...

Here, we compared macrovascular and microvascular outcomes in 1,657 patients (65.7% female) with type 2 diabetes and obesity who underwent metabolic surgery ...

Child Welfare Outcomes

Children's Bureau research on child welfare issues includes a series of annual Child Welfare Outcomes Reports to Congress. These reports include data from the ...

OUTCOME Definition & Meaning

The meaning of OUTCOME is something that follows as a result or consequence. How to use outcome in a sentence.

Phase 2 COURAGE Trial Confirms Trevogrumab Prevents ...

The safety and efficacy of trevogrumab and olatorepatide have not been evaluated by any regulatory authority. About Regeneron in Obesity Obesity ...

Олаторепатид при Избыточный вес или ожирение - ICH GCP

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to ...

Study of Olatorepatide in Adult Participants Living With ...

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 ...

REGN @ WF HC Conference - Fireside Chat Transcript

We also anticipate initiating our pivotal studies for obesity and type 2 diabetes with olatorepatide, which we in-licensed from Hansoh last ...

Novo Nordisk Downgraded Amid Mixed Data and ...

The race to develop the first highly effective oral obesity pill is heating up — and a new contender has just delivered impressive clinical data ...