34 Participants NeededMy employer runs this trial

Eloralintide for Obesity

Recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a new treatment called eloralintide, a potential drug for obesity, affects the body's processing of oral contraceptives in women who are overweight or have obesity. Participants will stay in a research unit three times, each for about a week, over eight months. This trial might be suitable for those with a stable body weight, a BMI between 27 and 35, and who use non-hormonal birth control methods. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

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

Research has shown that eloralintide is generally safe for people. In studies, many participants experienced significant weight loss with this treatment. Some side effects occurred, but they were usually mild. Most participants did not face serious health issues. Earlier research on adults with obesity or who were overweight found that the treatment was well-tolerated. This suggests that eloralintide is likely safe, although individual reactions can differ.12345

Why do researchers think this study treatment might be promising?

Eloralintide is unique because it offers a new approach to tackling obesity by being combined with a contraceptive, which is not the norm for current treatments like lifestyle changes, medications such as phentermine, or surgeries like gastric bypass. This combination could potentially address both weight management and hormonal balance in one go. Researchers are excited about Eloralintide because it is administered subcutaneously, which might offer a more consistent delivery method than oral pills, potentially leading to better outcomes in managing obesity.

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

Research has shown that eloralintide, a new treatment tested in this trial, offers promising results for weight loss in people with obesity. In earlier studies, participants lost up to 11.3% of their body weight in 12 weeks. Another study found that higher doses led to an average weight loss of up to 20% over 48 weeks. This treatment mimics the effects of amylin, a hormone that helps control appetite and food intake. Early evidence suggests that eloralintide could match the effectiveness of some of the best weight-loss treatments available today. Participants in this trial will receive eloralintide combined with an oral contraceptive.56789

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 women who are overweight or have obesity. Participants must be able to take oral contraceptives and stay in a research facility several times during the study.

Inclusion Criteria

Have safety laboratory test results within normal reference range for the population or investigative site
Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening
Have a body mass index (BMI) within the range of 27.0 to 35.0 kilograms per square meter (kg/m²), inclusive
See 1 more

Exclusion Criteria

I have or had conditions that make birth control pills unsafe for me.
I have a history of blood clots or related conditions.
Are pregnant or intend to become pregnant or to breastfeed during the study
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eloralintide subcutaneously and combined oral contraceptive orally

8 months
3 stays in the Clinical Research Unit, each lasting 6-8 nights

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide (LY3841136)

Trial Overview

The study tests how a new drug called eloralintide affects the way the body handles birth control pills in women with overweight or obesity. The trial lasts about 8 months, including three short stays at a clinic.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Eloralintide and combined oral contraceptiveExperimental Treatment2 Interventions

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

Eloralintide and Amycretin: Amylin and GLP-1 Receptor ...

Eloralintide and amycretin are investigational amylin and GLP-1 receptor agonists. Learn the mechanisms and what Phase 1/2 trial data shows.

Eloralintide, a Selective, Long-Acting Amylin Receptor ...

Observed body weight reductions were comparable to those reported in early trials of once-weekly eloralintide (up to 11.3% after 12 weeks) [22] and cagrilintide ...

Eloralintide: What We Know About This New Weight Loss ...

In a 48-week study, higher doses led to up to 20% average weight loss, putting it in the same conversation as some of today's most effective ...

A Study of Eloralintide (LY3841136) and ... - ClinicalTrials.Veeva

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may ...

Lilly's amylin data impress with 11% weight loss, tolerability

Eli Lilly's phase 1 amylin data impress analysts, pairing 11% weight loss with tolerable profile ... Eli Lilly has shared phase 1 data on amylin ...

A study to evaluate the efficacy and safety of eloralintide ...

This Phase 3 clinical trial studies the safety and effectiveness of once-weekly Eloralintide injections in adults living with obesity, ...

A Study to Investigate Weight Management With ... - Lilly Trials

The main purpose of this study, performed under the master protocol W8M-MCCWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for ...

Eli Lilly's Eloralintide Phase 2 Trial shows up to 20% ...

The 48-week randomized, placebo-controlled trial demonstrated meaningful and dose-dependent weight loss, with reductions ranging from 9.5% to ...

Eloralintide and Amycretin: Amylin and GLP-1 Receptor ...

What the evidence actually shows: Phase 1/2 data in humans demonstrates clinically meaningful weight loss for both compounds; Phase 3 data has ...