A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy; Type 2 Diabetes Mellitus (T2D)

Treatments: Drug: LY3549492; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06869018

J3H JE GZNG (Other Identifier)

27338

Details and patient eligibility

About

The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Part A:

• Participants with T2DM for at least 6 months

• With an HbA1c value:

  • equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR
  • equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications

• Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change

Part B:

• Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results

Exclusion criteria

• Have a known clinically significant gastric emptying abnormality
• Have a 12-lead electrocardiogram (ECG) abnormality
• Have an abnormal blood pressure or pulse rate
• Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
• Have a history of chronic medical conditions involving the heart, liver, or kidneys

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 4 patient groups, including a placebo group

LY3549492 Part A

Experimental group

Description:

LY3549492 administered orally

Treatment:

Drug: LY3549492

LY3549492 Part B

Experimental group

Description:

LY3549492 administered orally

Treatment:

Drug: LY3549492

Placebo Part A

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

Placebo Part B

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo