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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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) ≥7.0% and ≤10.5% at screening
• Have a BMI of 27 to 45 kg/m2 at screening
Locations
United States
Florida
Fortrea Clinical Research Unit
RECRUITING
Daytona Beach
Texas
Fortrea Clinical Research Unit
RECRUITING
Dallas
Endeavor Clinical Trials
RECRUITING
San Antonio
Other Locations
Singapore
Lilly Centre for Clinical Pharmacology
COMPLETED
Singapore
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2025-04-23
Estimated Completion Date:2026-04
Participants
Target number of participants:186
Treatments
Experimental: Part A: LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 orally
Placebo_comparator: Part A: Placebo Single Dose (Healthy Participants)
Participants will receive a single dose of placebo orally
Experimental: Part A: LY4086940 Multiple Dose (Healthy Participants)
Participants will receive LY4086940 orally for 3 days
Placebo_comparator: Part A: Placebo Multiple Dose (Healthy Participants)
Participants will receive placebo orally for 3 days
Experimental: Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
Placebo_comparator: Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)
Participants will receive placebo orally for 4 weeks
Experimental: Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
Placebo_comparator: Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity
Participants will receive placebo orally for 4 weeks
Experimental: Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
Placebo_comparator: Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive placebo orally for 4 weeks
Experimental: Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 intravenously (IV)