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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Type 2 Diabetes Mellitus (T2D)
• Intervention / Treatment: Drug: Placebo; Drug: LY3549492

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Hakata Clinic
  • Hachiōji, Japan, 192-0071
    • P-One Clinic
  • Osaka, Japan, 532-0003
    • Medical Corporation Heishinkai OPHAC Hospital
  • Shinjuku-ku, Japan, 160-0004
    • Clinical Research Hospital Tokyo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Part A; Placebo administered orally	Drug: Placebo; Administered orally
Placebo Comparator: Placebo Part B; Placebo administered orally	Drug: Placebo; Administered orally
Experimental: LY3549492 Part A; LY3549492 administered orally	Drug: LY3549492; Administered orally
Experimental: LY3549492 Part B; LY3549492 administered orally	Drug: LY3549492; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module	Day 1 Through Day 127

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
• Additional Relevant MeSH Terms: Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 27338; J3H-JE-GZNG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No