A Study of LY3549492 in Healthy Weight Adult Participants

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Healthy

Treatments: Drug: LY3549492; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07085468

27357

J3H-MC-GZNI (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).

Participation in the study will last about 13 months.

Enrollment: 220 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) within the range of 22 to 25 kilograms per square meter (kg/m2)
• Have had a stable body weight for 3 months prior to screening

Exclusion criteria

• Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma

• Have:

  • type 2 diabetes and on antidiabetic therapy (except type 2 diabetes being managed with diet and/or stable dose of metformin)
  • rare forms of diabetes mellitus, or
  • hemoglobin A1c (HbA1c) >8%

• Have poorly controlled hypertension

• Have any of the following cardiovascular conditions within 12 months prior to screening:

  • acute myocardial infarction
  • stroke
  • unstable angina, or
  • hospitalization due to congestive heart failure.

• Have a history of New York Heart Association Functional Classification III or IV congestive heart failure

• Have signs and symptoms of liver disease

• Have a history of pancreatitis

• Have taken medications or alternative remedies for weight loss or weight gain within 3 months prior to screening

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 3 patient groups, including a placebo group

LY3549492 Dose 1

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 2

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo