Brenipatide for Obesity

Not currently recruiting at 2 trial locations
Pi
Tq
Overseen ByTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called brenipatide for individuals with overweight or obesity. The main goal is to assess the treatment's safety and effectiveness at various doses. Participants will receive injections under the skin and might also receive a placebo, which contains no active drug. This study targets those who are generally healthy, have a BMI between 27 and 45, and have not experienced major weight changes in the last three months. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you have not used certain weight loss medications or specific diabetes-related medications in the 6 months before joining. If you're taking these, you would need to stop them before participating.

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

Earlier studies have tested brenipatide for safety in individuals who are overweight or obese. These studies examine how well different doses are tolerated when injected under the skin. So far, participants have generally tolerated the treatment well, with most experiencing no harmful reactions. There have been no major reports of serious side effects. However, as with any new treatment, some individuals might experience mild reactions, such as minor discomfort at the injection site. It is important to note that this treatment is still in early testing, and further research is needed to fully understand its safety.12345

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

Brenipatide is unique because it is administered subcutaneously, which is different from many current oral medications for obesity. Researchers are excited about Brenipatide because it could offer an alternative way to help manage weight by potentially targeting underlying biological mechanisms more directly. While most obesity treatments focus on appetite suppression or calorie absorption, Brenipatide might work differently, which could mean fewer side effects and improved outcomes for patients.

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

Research shows that brenipatide is a new treatment being tested for obesity in this trial. Participants in one arm of the trial will receive brenipatide, which affects specific parts of the body that control hunger and energy use. Early results suggest that medicines like this can lead to significant weight loss. However, brenipatide might not be as effective as other treatments, such as semaglutide. Initial studies on similar treatments have shown they can help people lose a significant amount of weight over a few months. These results are promising, but more research is needed to fully understand its effectiveness.14567

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 27 and 45 who are overweight or have obesity, but do not have diabetes or other major health problems related to weight. Participants should not be pregnant, breastfeeding, or taking weight loss medications.

Inclusion Criteria

My weight has stayed mostly the same over the past 3 months.
I am healthy and do not have diabetes or heart problems related to my weight.
My BMI is between 27.0 and 45.0.

Exclusion Criteria

Are pregnant or lactating
I do not have serious health problems with my heart, lungs, liver, kidneys, or other major organs.
I have had pancreatitis in the past.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of brenipatide or placebo via subcutaneous injections

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brenipatide
  • Placebo

Trial Overview

The study tests different doses of brenipatide (given as injections under the skin) compared to placebo in people with overweight or obesity. The main goals are to see how safe brenipatide is and how it works over about 42 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BrenipatideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Real‐world evidence on the utilization, clinical and ... - PMC

The percentage weight reduction over typically 6–12 months of follow‐up thus ranged from 2.2% to 18.5% for liraglutide, , 4.4% to 19.5% for ...

A Study of LY3537031 in Overweight, Obese, and Healthy ...

There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

A Study of Brenipatide (LY3537031) in Healthy Participants ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

Brenipatide for Obesity · Recruiting Participants for Phase ...

The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with overweight or ...

Advancing obesity treatments through innovations in the ...

The relatively low in vivo efficacy compared to semaglutide and notably Met097i will challenge its competitive edge and further development. Brenipatide is a ...

A Study of Brenipatide (LY3537031) in Healthy Participants ...

The main purpose of this study is to evaluate how different dose levels of brenipatide work and how safe they are in healthy people with ...

Brenipatide (LY-3537031) | GLP-1R/GIPR Agonist

Brenipatide can be used for the study of metabolic disorders, obesity and diabetes. ... SAFETY DATA SHEET (SDS). Request for HNMR Report. We have received your ...