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

Last updated: June 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

LY3549492

Placebo

Clinical Study ID

NCT06869018
27338
J3H JE GZNG
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 forparticipants treated with diet and exercise alone, OR

  • equal to or greater than 6.5% and equal to or less than 9.0% for participantsprior to washout of antidiabetic medications

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

Part B:

  • Have safety laboratory test results within normal reference range for the populationor investigative site, or results with acceptable deviations that are judged to benot clinically significant by the investigator. Laboratory tests may be repeated ifthere is a documented technical error, or once at the discretion of the investigatorfor any out-of-range results

Exclusion

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 ofcomorbidities capable of altering the absorption, metabolism, or elimination ofdrug. Or constituting a risk when taking the study drug

  • Have a history of chronic medical conditions involving the heart, liver, or kidneys

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: LY3549492
Phase: 1
Study Start date:
May 07, 2025
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka-shi, Osaka 532-0003
    Japan

    Active - Recruiting

  • P-One Clinic

    Hachioji, Tokyo 192-0071
    Japan

    Active - Recruiting

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo 160-0004
    Japan

    Site Not Available

  • Hakata Clinic

    Fukuoka, 812-0025
    Japan

    Active - Recruiting

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