A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT03115099
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3325656 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally
  • Liraglutide — DRUG
    Administered subcutaneously
  • Sitagliptin — DRUG
    Administered orally

Study Details

The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected. It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it. The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.

Key Dates

Start date
May 31, 2017
Status verified
Aug 2018
Primary completion
Apr 5, 2018
Completion
Apr 5, 2018

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo (Part A)
    Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
  • Experimental: LY3325656 (Part A)
    Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
  • Placebo Comparator: Placebo (Part B)
    Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
  • Experimental: LY3325656 (Part B)
    Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
  • Active Comparator: Liraglutide (Part B)
    Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
  • Experimental: LY3325656 + Sitagliptin (Part B)
    Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B

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 approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively ]

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