Evaluating LY4086940 in Healthy Individuals and Those with Overweight or Obesity
A Single-Dose and Multiple-Ascending Dose Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
This study is testing a new drug called LY4086940 to see if it's safe and helps with weight management in healthy people and those with overweight or obesity, including those with type 2 diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 5 sites (Daytona Beach, Florida and 4 other locations) |
| Trial ID | NCT06945419 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of LY4086940 in healthy participants and those with overweight or obesity, including individuals with type 2 diabetes. Participants will be divided into different groups based on their health status and body mass index (BMI), with the study lasting approximately 10 to 15 weeks depending on the group. The study will involve multiple visits to monitor how the drug is processed in the body and its effects on weight management. Participants will receive either the investigational drug or a placebo during the trial.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals with a BMI of 22 to 35, individuals with overweight or obesity (BMI 27 to 45), and those with type 2 diabetes.
Not a fit: Patients with significant recent weight changes, acute cardiovascular conditions, liver disease, or type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for weight management and type 2 diabetes.
How similar studies have performed: Other studies have shown promise with similar approaches targeting weight management and type 2 diabetes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have no significant body weight change for the 3 months prior to screening Part A and Part E: * Are considered healthy * Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at 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 Part D: * Have type 2 diabetes * Have hemoglobin A1C (HbA1c) ≥6.5% and ≤10.5% at screening * Have a BMI of 27 to 45 kg/m2 at screening Exclusion Criteria: * Have had an acute cardiovascular condition within the past 6 months prior to screening * Have liver disease or pancreatitis * Have used medications for weight loss within the 3 months prior to screening Parts A, B, C, E: * Have any form of diabetes Part D: * Have type 1 diabetes
Where this trial is running
Daytona Beach, Florida and 4 other locations
- Fortrea Clinical Research Unit — Daytona Beach, Florida, United States (Completed)
- Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Completed)
- Endeavor Clinical Trials — San Antonio, Texas, United States (Active_not_recruiting)
- Lilly Centre for Clinical Pharmacology — Singapore, Singapore (Completed)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.