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

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Lilly

Status and phase

Not yet enrolling
Phase 1

Conditions

Overweight
Healthy
Obesity
Type 2 Diabetes

Treatments

Drug: LY4086940
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06945419
J5U-MC-YGAA (Other Identifier)
27267

Details and patient eligibility

About

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.

Enrollment

165 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

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:

  • Have any form of diabetes

Part D:

  • Have type 1 diabetes

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

165 participants in 10 patient groups, including a placebo group

Part A: LY4086940 Single Dose (Healthy Participants)
Experimental group
Description:
Participants will receive a single dose of LY4086940 orally
Treatment:
Drug: LY4086940
Part A: Placebo Single Dose (Healthy Participants)
Placebo Comparator group
Description:
Participants will receive a single dose of placebo orally
Treatment:
Drug: Placebo
Part A: LY4086940 Multiple Dose (Healthy Participants)
Experimental group
Description:
Participants will receive LY4086940 orally for 3 days
Treatment:
Drug: LY4086940
Part A: Placebo Multiple Dose (Healthy Participants)
Placebo Comparator group
Description:
Participants will receive placebo orally for 3 days
Treatment:
Drug: Placebo
Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)
Experimental group
Description:
Participants will receive LY4086940 orally for 4 weeks
Treatment:
Drug: LY4086940
Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)
Placebo Comparator group
Description:
Participants will receive placebo orally for 4 weeks
Treatment:
Drug: Placebo
Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)
Experimental group
Description:
Participants will receive LY4086940 orally for 4 weeks
Treatment:
Drug: LY4086940
Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity
Placebo Comparator group
Description:
Participants will receive placebo orally for 4 weeks
Treatment:
Drug: Placebo
Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Experimental group
Description:
Participants will receive LY4086940 orally for 4 weeks
Treatment:
Drug: LY4086940
Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Placebo Comparator group
Description:
Participants will receive placebo orally for 4 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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