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

Sponsor
Eli Lilly and Company
Study ID
NCT06869018
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Type 2 Diabetes Mellitus (T2D)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3549492 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
Mar 2026
Primary completion
Mar 2, 2026
Completion
Mar 2, 2026

Study Design

Enrollment
92 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3549492 Part A
    LY3549492 administered orally
  • Experimental: LY3549492 Part B
    LY3549492 administered orally
  • Placebo Comparator: Placebo Part A
    Placebo administered orally
  • Placebo Comparator: Placebo Part B
    Placebo administered orally

Primary Outcome 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 [ Time Frame: Day 1 Through Day 127 ]

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