Clinical trial NCT06869018: A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Type 2 Diabetes Mellitus (T2D)
Keywords: Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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
timeFrame: Day 1 Through Day 127
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492
timeFrame: Day 1 Through Day 127
measure: PK: Maximum Concentration (Cmax) of LY3549492
timeFrame: Day 1 Through Day 127
measure: Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Day 1 Through Day 127
measure: PD: Change from Baseline in Body Weight
timeFrame: Day 1 Through Day 127
Other outcomes:
Locations:
city: Osaka-shi
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
state: Osaka
city: Hachioji
country: Japan
facility: P-One Clinic
state: Tokyo
city: Fukuoka
country: Japan
facility: Hakata Clinic
Study officials:
affiliation: Eli Lilly and Company
name: Contact Lilly at 1-800-LillyRx (1-800-545-5979)
role: STUDY_DIRECTOR
References: