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

NCT ID: NCT06869018

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Healthy Type 2 Diabetes Mellitus (T2D)

Keywords

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Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3549492 Part A

LY3549492 administered orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

LY3549492 Part B

LY3549492 administered orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

Placebo Part A

Placebo administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Placebo Part B

Placebo administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3549492

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Hakata Clinic

Fukuoka, , Japan

Site Status

P-One Clinic

Hachiōji, , Japan

Site Status

Medical Corporation Heishinkai OPHAC Hospital

Osaka, , Japan

Site Status

Clinical Research Hospital Tokyo

Shinjuku-ku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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J3H-JE-GZNG

Identifier Type: OTHER

Identifier Source: secondary_id

27338

Identifier Type: -

Identifier Source: org_study_id