A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06132126
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3938577 — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.
  • Insulin degludec — DRUG
    Administered SC.

Study Details

The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.

Key Dates

Start date
Nov 17, 2023
Status verified
Jul 2024
Primary completion
Jun 28, 2024
Completion
Jun 28, 2024

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3938577 (Part A)
    LY3938577 administered Subcutaneously (SC).
  • Placebo Comparator: Placebo (Part A)
    Placebo administered SC.
  • Active Comparator: Insulin degludec (Part A)
    Insulin degludec administered SC.
  • Experimental: LY3938577 (Part B)
    LY3938577 administered SC.
  • Active Comparator: Insulin degludec (Part B)
    Insulin degludec administered SC.

Primary Outcome Measure

Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration [ Time Frame: Baseline up to 16 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
CenExel ACTAnaheimCalifornia92801-
Qps-Mra, LlcMiamiFlorida33143-
Labcorp CRUDallasTexas75247-

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