A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

Sponsor
Eli Lilly and Company
Study ID
NCT06280703
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • LY3938577 — DRUG
    Administered Intravenously (IV)
  • Placebo — DRUG
    Administered Intravenously (IV)
  • Insulin Degludec — DRUG
    Administered Intravenously (IV)
  • Insulin Lispro — DRUG
    Administered Intravenously (IV)
  • LY3938577 — DRUG
    Administered subcutaneously (SC)
  • Placebo — DRUG
    Administered subcutaneously (SC)
  • Insulin Degludec — DRUG
    Administered SC
  • Basal Insulin — DRUG
    Administered subcutaneously (SC)
  • Lispro Prandial Insulin — DRUG
    Administered subcutaneously (SC)

Study Details

The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in four parts (A, B, C, and D). Healthy participants in Part A Period 1 will receive a single dose of LY3938577 or a placebo given via intravenous (IV) infusion. In Part A Period 2, participants will receive a single subcutaneous (SC) dose of either LY3938577 or placebo. Participants in Part B with Type 1 Diabetes Mellitus (T1DM) will receive single doses of either LY3938577 or Insulin Degludec given via IV infusion. Participants in Part C with Type 1 Diabetes Mellitus (T1DM) will receive two doses of either LY3938577 or Insulin Degludec administered SC. Participants in Part D with Type 1 Diabetes Mellitus (T1DM) will be evaluated in 2 periods, with Period 1 administered pre-study basal insulin and lispro mealtime insulin to establish insulin needs, and Period 2 administered lispro mealtime insulin and daily doses of LY3938577. The study will last up to approximately 11 weeks for Part A, 10 weeks for Part B, 13 weeks for Part C, and 10 weeks for Part D , including screening period.

Key Dates

Start date
May 15, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A Period 1: LY3938577
    Single dose of LY3938577 administered intravenously (IV) in healthy participants.
  • Placebo Comparator: Part A Period 1: Placebo
    Single dose of Placebo administered intravenously (IV) in healthy participants.
  • Experimental: Part B: LY3938577
    For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of LY3938577 administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level.
  • Active Comparator: Part B: Insulin Degludec
    For each euglycemic and hyperglycemic clamps participants with T1DM will receive single doses of Insulin Degludec administered intravenously with Insulin Lispro administered at a constant low rate to cover individual participant's basal (fasting) insulin demand to maintain a stable glucose level.
  • Experimental: Part C: LY3938577
    LY3938577 administered subcutaneously (SC)
  • Active Comparator: Part C: Insulin Degludec
    Insulin Degludec administered subcutaneously (SC)
  • Experimental: Part A Period 2: LY3938577
    Sequential dose of LY3938577 administered subcutaneously (SC).
  • Placebo Comparator: Part A Period 2: Placebo
    Sequential dose of Placebo administered subcutaneously (SC)
  • Other: Part D Period 1: Basal Insulin and Lispro Prandial Insulin
    Pre-study basal insulin (provided by patient) and lispro prandial insulin administered SC
  • Experimental: Part D Period 2: Lispro Prandial Insulin and LY3938577
    Lispro prandial insulin and LY3938577 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 Approximately Week 11 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

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