A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05377333
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in 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 will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.

Key Dates

Start date
Jun 2, 2022
Status verified
Jan 2024
Primary completion
Nov 22, 2023
Completion
Nov 22, 2023

Study Design

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

Arms

  • Experimental: LY3457263 (Alone)
    LY3457263 administered subcutaneously (SC).
  • Placebo Comparator: Placebo (Alone)
    Placebo administered SC.
  • Experimental: LY3457263 + Dulaglutide
    LY3457263 in combination with dulaglutide administered SC.
  • Experimental: Placebo + Dulaglutide
    Placebo in combination with dulaglutide administered SC.

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: Predose up to 16 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
CenExel ACTAnaheimCalifornia92801-
Qps-Mra, LlcSouth MiamiFlorida33143-
Atlanta Center of Medical ResearchAtlantaGeorgia30331 2012-
CenExel-HRIBerlinNew Jersey08009-

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