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

Purpose

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.

Conditions

  • Healthy
  • Overweight
  • Obesity
  • Type 2 Diabetes

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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) ≥7.0% 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: LY4086940 Single Dose (Healthy Participants) 		Participants will receive a single dose of LY4086940 orally
  • Drug: LY4086940
    Administered orally
Placebo Comparator
Part A: Placebo Single Dose (Healthy Participants) 		Participants will receive a single dose of placebo orally
  • Drug: Placebo
    Administered orally
Experimental
Part A: LY4086940 Multiple Dose (Healthy Participants) 		Participants will receive LY4086940 orally for 3 days
  • Drug: LY4086940
    Administered orally
Placebo Comparator
Part A: Placebo Multiple Dose (Healthy Participants) 		Participants will receive placebo orally for 3 days
  • Drug: Placebo
    Administered orally
Experimental
Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) 		Participants will receive LY4086940 orally for 4 weeks
  • Drug: LY4086940
    Administered orally
Placebo Comparator
Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) 		Participants will receive placebo orally for 4 weeks
  • Drug: Placebo
    Administered orally
Experimental
Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) 		Participants will receive LY4086940 orally for 4 weeks
  • Drug: LY4086940
    Administered orally
Placebo Comparator
Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity 		Participants will receive placebo orally for 4 weeks
  • Drug: Placebo
    Administered orally
Experimental
Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) 		Participants will receive LY4086940 orally for 4 weeks
  • Drug: LY4086940
    Administered orally
Placebo Comparator
Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) 		Participants will receive placebo orally for 4 weeks
  • Drug: Placebo
    Administered orally
Experimental
Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) 		Participants will receive a single dose of LY4086940 intravenously (IV)
  • Drug: LY4086940
    Administered IV

Recruiting Locations

Fortrea Clinical Research Unit
Daytona Beach 4152872, Florida 4155751 32117
Contact:
866-429-3700

Fortrea Clinical Research Unit
Dallas 4684888, Texas 4736286 75247
Contact:
866-429-3700

Endeavor Clinical Trials
San Antonio 4726206, Texas 4736286 78240
Contact:
210-634-1253

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com