A Study to Investigate the Effect of LY4086940 Versus Placebo in Participants With Obesity or Overweight and Without Type 2 Diabetes

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: LY4086940; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07890376

27946

W8M-MC-OG01 (Other Identifier)

Details and patient eligibility

About

The purpose of this study, performed under the master protocol W8M-MC- CWMM (NCT06143956), is to evaluate the efficacy and safety of LY4086940 compared with placebo in participants without type 2 diabetes who have obesity or who have overweight with a weight-related health condition.

Participation in the study will last about 58 weeks.

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet inclusion criteria under Master Protocol CWMM (NCT06143956)

Exclusion criteria

In addition to exclusion criteria under Master Protocol CWMM (NCT06143956)

• Have any prior diagnosis of type 2 diabetes, type 1 diabetes, or rare forms of diabetes mellitus, except gestational diabetes

• Have a laboratory value suggestive of diabetes

• Have any of the following cardiovascular conditions within 6 months prior to screening:

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure

• Have a known personal or family history (first-degree relative) of multiple endocrine neoplasia type 2A or 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.

• Within 6 months prior to screening, have taken medications (prescribed or over the counter) or alternative remedies (including herbal or nutritional supplements) that promote weight loss

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 10 patient groups, including a placebo group

LY4086940 Dose 1

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 2

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 3, Titration Schedule A

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 3, Titration Schedule B

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 4

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 5

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 6, Titration Schedule A

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 6, Titration Schedule B

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

LY4086940 Dose 6, Titration Schedule C

Experimental group

Description:

Participants will receive LY4086940 orally

Treatment:

Drug: LY4086940

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo