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

Phase 1

Not yet recruiting

• Conditions: Healthy; Type 2 Diabetes Mellitus (T2D)
• Interventions: Drug: LY3549492; Drug: Placebo

• Registration Number: NCT06869018
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3549492 Part A	LY3549492	LY3549492 administered orally
LY3549492 Part B	LY3549492	LY3549492 administered orally
Placebo Part A	Placebo	Placebo administered orally
Placebo Part B	Placebo	Placebo administered orally

Primary Outcome Measures

Name	Time	Method
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	Day 1 Through Day 127	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of LY3549492	Day 1 Through Day 127	PK: Cmax of LY3549492
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492	Day 1 Through Day 127	PK: AUC of LY3549492
Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)	Day 1 Through Day 127	PD: Change from Baseline in Hemoglobin A1c (HbA1c)
PD: Change from Baseline in Body Weight	Day 1 Through Day 127	PD: Change from Baseline in Body Weight

Trial Locations

Locations (3)

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

P-One Clinic; 🇯🇵 Hachioji, Tokyo, Japan

Hakata Clinic; 🇯🇵 Fukuoka, Japan