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

Conditions

• Healthy
• Obesity
• Overweight
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• LY4086940 — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally
• LY4086940 — DRUG
  Administered IV

Study Details

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 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.

Key Dates

Start date

Apr 23, 2025

Status verified

May 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• 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 4-6 weeks
• Placebo Comparator: Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
  Participants will receive placebo orally for 4-6 weeks
• Experimental: Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)
  Participants will receive a single dose of LY4086940 intravenously (IV)

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Week 9 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (4)

Find similar trials in Daytona Beach, FL

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