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

Launched by ELI LILLY AND COMPANY · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called LY3549492 to see how well it is tolerated by Japanese participants, both those with Type 2 Diabetes Mellitus (T2D) and healthy individuals. The main goal is to understand any side effects that might occur when taking the medication and how the body processes it. Participants will take the study drug by mouth, and researchers will conduct blood tests to measure how much of the drug enters the bloodstream and how quickly the body eliminates it. The study will last about 19 weeks for participants in different groups, with a total duration of around 25 weeks including the initial screening process.

To be eligible for this study, participants with T2D should have had the condition for at least six months and meet certain blood sugar level criteria. They should also have stable weight for the three months leading up to the study. Healthy participants are also welcome to join. However, individuals with certain health issues, like serious heart or kidney problems, or those who have experienced significant medical changes recently, will not be able to participate. This study is not yet recruiting, but it promises to provide valuable information about the safety and effects of LY3549492 for people with T2D and healthy individuals alike.

Gender

ALL

Eligibility criteria

• 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