A Study of LY3537021 in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT05444569
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • LY3537021 — DRUG
    Administered SC.
  • Liraglutide — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.

Study Details

The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.

Key Dates

Start date
Aug 8, 2022
Status verified
Feb 2023
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023

Study Design

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

Arms

  • Experimental: LY3537021 + Liraglutide (Part A)
    Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.
  • Experimental: Liraglutide + Placebo (Part A)
    Liraglutide administered SC followed by liraglutide in combination with placebo given SC.
  • Experimental: LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)
    LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.
  • Experimental: Placebo + Liraglutide & LY3537021 + Liraglutide Part B)
    Placebo administered SC followed by liraglutide administered SC in treatment period 1. LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.

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: Baseline up to Week 22 ]

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