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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.