A Study of LY3549492 in Participants With Type 2 Diabetes Mellitus (T2DM)

Sponsor
Eli Lilly and Company
Study ID
NCT05327595
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3549492 — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.
  • Atorvastatin — DRUG
    Administered orally.
  • Midazolam — DRUG
    Administered orally.

Study Details

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in participants with T2DM. Blood tests will be done to check how much LY3549492 gets into the bloodstream and how the body handles LY3549492. This study has two parts. Each participant will enroll in only one part. The study will last either 12 or 13 weeks, depending on part.

Key Dates

Start date
May 9, 2022
Status verified
May 2024
Primary completion
Apr 22, 2024
Completion
Apr 22, 2024

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3549492 (Part A)
    LY3549492 administered orally as multiple ascending doses.
  • Placebo Comparator: Placebo (Part A)
    Placebo administered orally.
  • Experimental: LY3549492 + Midazolam + Atorvastatin (Part B)
    LY3549492 coadministered orally with midazolam and atorvastatin.
  • Placebo Comparator: Placebo + Midazolam + Atorvastatin (Part B)
    Placebo coadministered orally with midazolam and atorvastatin.

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through final follow-up at approximately Day 49 ]

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