A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT04641312
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY3457263 — DRUG
    Administered SC
  • Dulaglutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study has two parts (part A and B). Each part will last up to 10 weeks and may include up to either 13 (part A) or 19 (part B) visits.

Key Dates

Start date
Nov 25, 2020
Status verified
Jan 2022
Primary completion
Dec 21, 2021
Completion
Dec 21, 2021

Study Design

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

Arms

  • Experimental: LY3457263 - Part A
    Escalating single doses of LY3457263 administered subcutaneously (SC) to healthy participants
  • Placebo Comparator: Placebo - Part A
    Placebo administered SC to healthy participants
  • Experimental: LY3457263 - Part B
    Escalating single doses of LY3457263 administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes
  • Placebo Comparator: Placebo - Part B
    Placebo administered SC in combination with Dulaglutide administered SC to participants with type 2 diabetes

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 Day 42 ]

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