NCT06869018CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 10 Mar 2025
- Start date
- 7 May 2025
- Primary completion date
- 2 Mar 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06869018
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 92
- From 7 May 2025 to the primary completion date, 2 Mar 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have a history of chronic medical conditions involving the heart, liver, or kidneys
Other
- Have a known clinically significant gastric emptying abnormality
- Have a 12-lead electrocardiogram (ECG) abnormality
- Have an abnormal blood pressure or pulse rate
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hakata Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| P-One Clinic Coordinator of this site? Confirm its status | Hachiōji | Japan | Unknown status |
| Medical Corporation Heishinkai OPHAC Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Clinical Research Hospital Tokyo Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.