LY4086940 for Obesity

Recruiting at 2 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Acute cardiovascular, Liver disease, Pancreatitis, others

Compensation: Varies

Number of Visits: 15

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the new treatment, LY4086940, functions in the body and its safety for individuals with obesity. The study includes several parts, testing the treatment on different groups, such as healthy individuals and those with type 2 diabetes. Participants should maintain a stable weight for a few months and meet specific BMI (body mass index) criteria. Individuals with type 2 diabetes and a BMI between 27 and 45 may qualify for Part D of the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used weight loss medications in the 3 months before screening.

Is there any evidence suggesting that LY4086940 is likely to be safe for humans?

A previous study tested LY4086940 on healthy individuals to assess its safety and how their bodies process it. The study focused on safety and tolerability, evaluating how well participants tolerate the drug without issues. As a Phase 1 trial, the primary goal is to ensure the treatment's safety for humans.

Phase 1 trials represent the initial step in testing new treatments in people. They involve a small number of participants and concentrate mainly on safety. Although LY4086940 has been used in other studies, researchers are still in the early stages of understanding its safety for treating obesity.

In summary, this trial examines whether LY4086940 causes any side effects and how the body reacts to it. Participants will contribute to researchers' understanding of its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY4086940 because it offers a novel approach to addressing obesity, especially in individuals with type 2 diabetes. Unlike traditional treatments that primarily focus on lifestyle changes or medications like orlistat and phentermine, LY4086940 is an experimental drug administered orally that could potentially provide significant weight management benefits. This treatment may offer a new mechanism of action targeting metabolic processes, potentially leading to more effective weight loss in a shorter period. This innovative approach is what makes LY4086940 stand out from the current options.

What evidence suggests that LY4086940 might be an effective treatment for obesity?

Research has shown that LY4086940 might be a promising treatment for obesity. Early results suggest this drug could aid weight loss by affecting certain processes related to weight gain. The trial tests LY4086940 in various treatment arms to assess its safety and how the body processes it, particularly in overweight individuals, those with type 2 diabetes, and healthy participants. While detailed results are still forthcoming, focusing on safety and tolerance is crucial for understanding its potential benefits. As more information emerges, LY4086940 may offer a new approach to effectively managing obesity. ^{1 2 5 6 7}

Who Is on the Research Team?

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 individuals, as well as those with overweight or obesity, which may include people with type 2 diabetes. Participants will be involved in the study for about 10 to 15 weeks and must attend up to 9 visits.

Inclusion Criteria

Have no significant body weight change for the 3 months prior to screening

Part B: Have a BMI of 27 to 45 kg/m2 at screening

Part C: Have a BMI of 25 to 45 kg/m2 at screening

Exclusion Criteria

Part D: Have type 1 diabetes

I have diabetes.

I have had a heart condition in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive either a single dose or multiple doses of LY4086940 or placebo orally

10 weeks

Up to 6 visits

Treatment Parts B, C, D

Participants receive multiple doses of LY4086940 or placebo orally

15 weeks

Up to 9 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4086940

Trial Overview

The study is testing LY4086940 against a placebo to assess its safety and how it's processed by the body. The trial involves multiple parts (A, B, C, D), each potentially having different participant groups or dosages.

How Is the Trial Designed?

Group I: Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) Experimental Treatment 1 Intervention

Participants will receive a single dose of LY4086940 intravenously (IV)

Group II: Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) Experimental Treatment 1 Intervention

Participants will receive LY4086940 orally for 4 weeks

Group III: Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) Experimental Treatment 1 Intervention

Participants will receive LY4086940 orally for 4 weeks

Group IV: Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) Experimental Treatment 1 Intervention

Participants will receive LY4086940 orally for 4 weeks

Group V: Part A: LY4086940 Single Dose (Healthy Participants) Experimental Treatment 1 Intervention

Participants will receive a single dose of LY4086940 orally

Group VI: Part A: LY4086940 Multiple Dose (Healthy Participants) Experimental Treatment 1 Intervention

Participants will receive LY4086940 orally for 3 days

Group VII: Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) Placebo Group 1 Intervention

Participants will receive placebo orally for 4 weeks

Group VIII: Part A: Placebo Multiple Dose (Healthy Participants) Placebo Group 1 Intervention

Participants will receive placebo orally for 3 days

Group IX: Part A: Placebo Single Dose (Healthy Participants) Placebo Group 1 Intervention

Participants will receive a single dose of placebo orally

Group X: Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) Placebo Group 1 Intervention

Participants will receive placebo orally for 4 weeks

Group XI: Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity Placebo Group 1 Intervention

Participants will receive placebo orally for 4 weeks

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Obesity is a significant health issue linked to serious conditions like type 2 diabetes and cardiovascular disease, making effective treatment crucial for reducing related health risks.

Recent anti-obesity medications, such as phentermine/topiramate and lorcaserin, target biological mechanisms to suppress appetite and regulate body weight, offering more effective weight loss options for individuals with a BMI over 30 or those with related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current updates in the medical management of obesity. Khan, A., Raza, S., Khan, Y., et al.[2019]

Obesity, particularly childhood obesity, is a complex issue influenced by various factors including genetics, environment, and socioeconomic status, leading to serious health problems like diabetes and heart disease.

Surgical treatments, especially Roux-en-Y gastric bypass, are currently the most effective long-term solution for significant weight loss, achieving over 50% excess weight loss in more than 90% of patients, with follow-up studies lasting over 14 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of medical and surgical therapy for obesity. Mun, EC., Blackburn, GL., Matthews, JB.[2022]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Citations

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clinicaltrials.gov/study/NCT06945419?cond=diabetes

A Study of LY4086940 in Healthy Participants and ...

A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes · Study Overview · Contacts and ...

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trials.lilly.com

trials.lilly.com/en-US/trial/599675

A Study of LY4086940 in Healthy Participants and ... - Lilly Trials

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.

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LY4086940 for Obesity · Recruiting Participants for Phase ...

This trial is for healthy individuals, as well as those with overweight or obesity, which may include people with type 2 diabetes. Participants will be involved ...

4.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/33670215/eli-lillys-new-study-on-ly4086940-a-potential-game-changer-for-obesity-and-diabetes-treatment/

Eli Lilly's New Study on LY4086940: A Potential Game ...

The study aims to assess the safety and tolerability of LY4086940, a new drug, and understand how it is processed in the body. This research is ...

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linkedin.com

linkedin.com/posts/stellarint-cvrm_elililly-obesitytreatment-diabetesresearch-activity-7354100004032073731-0BYA

Eli Lilly's LY4086940: A New Obesity Treatment in the Works

Exciting Developments in Obesity Treatment!** Eli Lilly is making significant strides in the fight against obesity with their ongoing study of LY4086940, ...

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connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/599675

A Study of LY4086940 in Healthy Participants and Participants ...

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.

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ctv.veeva.com

ctv.veeva.com/study/a-study-of-ly4086940-in-healthy-participants-and-participants-with-overweight-or-obesity-with-or-wi

A Study of LY4086940 in Healthy Participants and Participants ...

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.