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CompletedNCT06869018Updated Mar 20, 2026

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

A Phase 1 interventional study of LY3549492 and Placebo in Healthy and Type 2 Diabetes Mellitus (T2D), sponsored by Eli Lilly and Company. Completed at 4 sites in Japan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Type 2 Diabetes Mellitus (T2D)

Keywords

  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 92 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    LY3549492 Part A

    LY3549492 administered orally

    Drug: LY3549492

  • Experimental
    LY3549492 Part B

    LY3549492 administered orally

    Drug: LY3549492

  • Placebo comparator
    Placebo Part A

    Placebo administered orally

    Drug: Placebo

  • Placebo comparator
    Placebo Part B

    Placebo administered orally

    Drug: Placebo

Interventions

  • DrugLY3549492

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

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

    Time frame: Day 1 Through Day 127

Secondary outcomes

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

    PK: AUC of LY3549492

    Time frame: Day 1 Through Day 127

  2. PK: Maximum Concentration (Cmax) of LY3549492

    PK: Cmax of LY3549492

    Time frame: Day 1 Through Day 127

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

    PD: Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Day 1 Through Day 127

  4. PD: Change from Baseline in Body Weight

    PD: Change from Baseline in Body Weight

    Time frame: Day 1 Through Day 127

07

Study locations

4 sites
  • Hakata Clinic
    Fukuoka, 812-0025, Japan
  • P-One Clinic
    Hachiōji, 192-0071, Japan
  • Medical Corporation Heishinkai OPHAC Hospital
    Osaka, 532-0003, Japan
  • Clinical Research Hospital Tokyo
    Shinjuku-ku, 160-0004, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06869018
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
May 7, 2025
Primary completion
Mar 2, 2026
Completion
Mar 2, 2026
Last update
Mar 20, 2026

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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