A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Sponsor
Eli Lilly and Company
Study ID
NCT05407961
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • LY3532226 — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.
  • Dulaglutide — DRUG
    Administered SC.

Study Details

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.

Key Dates

Start date
Jun 7, 2022
Status verified
Mar 2024
Primary completion
Jan 12, 2024
Completion
Jan 12, 2024

Study Design

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

Arms

  • Experimental: LY3532226 + Dulaglutide (Part A)
    LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.
  • Placebo Comparator: Placebo + Dulaglutide (Part A)
    Placebo administered SC followed by dulaglutide administered SC.
  • Active Comparator: Dulaglutide + Placebo (Part B)
    Dulaglutide administered SC in combination with placebo given SC.
  • Experimental: LY3532226 + Dulaglutide (Part B)
    LY3532226 administered SC in combination with Dulaglutide given SC.
  • Experimental: LY3532226 + Placebo (Part B)
    LY3532226 administered SC in combination with placebo given SC.

Primary Outcome Measure

Part A: 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: Baseline up to Week 16 ]

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