165 Participants Needed

LY4086940 for Obesity

Recruiting at 3 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Trial Summary

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.

How does the drug LY4086940 for obesity differ from other treatments?

The drug LY4086940 for obesity is unique because it may target specific genetic or metabolic pathways involved in obesity, unlike existing treatments that primarily focus on appetite suppression or nutrient absorption. This approach could offer a more personalized treatment option based on an individual's genetic makeup.12345

What is the purpose of this trial?

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 9 visits.

Research Team

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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
See 2 more

Exclusion Criteria

Part D: Have type 1 diabetes
I have diabetes.
I have had a heart condition in the last 6 months.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)Experimental Treatment1 Intervention
Participants will receive LY4086940 orally for 4 weeks
Group II: Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)Experimental Treatment1 Intervention
Participants will receive LY4086940 orally for 4 weeks
Group III: Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)Experimental Treatment1 Intervention
Participants will receive LY4086940 orally for 4 weeks
Group IV: Part A: LY4086940 Single Dose (Healthy Participants)Experimental Treatment1 Intervention
Participants will receive a single dose of LY4086940 orally
Group V: Part A: LY4086940 Multiple Dose (Healthy Participants)Experimental Treatment1 Intervention
Participants will receive LY4086940 orally for 3 days
Group VI: Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)Placebo Group1 Intervention
Participants will receive placebo orally for 4 weeks
Group VII: Part A: Placebo Multiple Dose (Healthy Participants)Placebo Group1 Intervention
Participants will receive placebo orally for 3 days
Group VIII: Part A: Placebo Single Dose (Healthy Participants)Placebo Group1 Intervention
Participants will receive a single dose of placebo orally
Group IX: Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)Placebo Group1 Intervention
Participants will receive placebo orally for 4 weeks
Group X: Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or ObesityPlacebo Group1 Intervention
Participants will receive placebo orally for 4 weeks

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

Findings from Research

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.
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.
Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches.Solas, M., Milagro, FI., Martรญnez-Urbistondo, D., et al.[2018]
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.
Current updates in the medical management of obesity.Khan, A., Raza, S., Khan, Y., et al.[2019]

References

Current status of medical and surgical therapy for obesity. [2022]
Obesity and common genetic metabolic disorders. [2019]
Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Current updates in the medical management of obesity. [2019]
Regional patterns of fat distribution. [2019]
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