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.
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:
• 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
ACTIVE_NOT_RECRUITING
Daytona Beach
Texas
Fortrea Clinical Research Unit
RECRUITING
Dallas
Endeavor Clinical Trials
NOT_YET_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: 165
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
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company