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Completed

NCT Number: NCT06869018

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hakata Clinic, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3549492

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Day 1 Through Day 127

    A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492

    Time frame: Day 1 Through Day 127

    PK: AUC of LY3549492

  2. PK: Maximum Concentration (Cmax) of LY3549492

    Time frame: Day 1 Through Day 127

    PK: Cmax of LY3549492

  3. Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Day 1 Through Day 127

    PD: Change from Baseline in Hemoglobin A1c (HbA1c)

  4. PD: Change from Baseline in Body Weight

    Time frame: Day 1 Through Day 127

    PD: Change from Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus and Healthy Japanese Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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