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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Healthy; Obesity; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: LY4086940

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

Enrollment: 186 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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 11 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

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

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

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

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

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

Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)

Experimental group

Description:

Participants will receive a single dose of LY4086940 intravenously (IV)

Treatment:

Drug: LY4086940

Drug: LY4086940