NCT06869018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2025

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 10, 2025

Last Update Submit

March 19, 2026

Conditions

Type 2 Diabetes Mellitus (T2D)Healthy

Keywords

Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes MellitusDiabetes Mellitus, Type 2

Outcome Measures

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

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

    Day 1 Through Day 127

Secondary Outcomes (4)

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

    Day 1 Through Day 127

  • PK: Maximum Concentration (Cmax) of LY3549492

    Day 1 Through Day 127

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

    Day 1 Through Day 127

  • PD: Change from Baseline in Body Weight

    Day 1 Through Day 127

Study Arms (4)

LY3549492 Part A

EXPERIMENTAL

LY3549492 administered orally

Drug: LY3549492

LY3549492 Part B

EXPERIMENTAL

LY3549492 administered orally

Drug: LY3549492

Placebo Part A

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

Placebo Part B

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

Interventions

LY3549492DRUG

Administered orally

LY3549492 Part ALY3549492 Part B
PlaceboDRUG

Administered orally

Placebo Part APlacebo Part B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

P-One Clinic

Hachiōji, 192-0071, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, 160-0004, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 11, 2025

Study Start

May 7, 2025

Primary Completion

March 2, 2026

Study Completion

March 2, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(4)