RecruitingPhase 1NCT06280703

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

A Four-Part, Randomized, Double-Blind (Part A) and Open-Label (Part B, Part C, and Part D), Multi-Dose, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus


Sponsor

Eli Lilly and Company

Enrollment

118 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called LY3938577 in both healthy volunteers and people with Type 1 Diabetes (T1D). The goal is to understand how the drug behaves in the body and whether it can help people with T1D better manage their blood sugar levels. **You may be eligible if...** - You are a healthy adult OR you have had Type 1 Diabetes for at least 1–2 years - Your blood sugar control is relatively stable (HbA1c between 6% and 8.5%) - You use an insulin pump with a total daily basal dose between 15–45 units (for some parts of the study) - You have a BMI between 18 and 35 kg/m² - You do not have hypoglycemia unawareness (you can feel when your blood sugar is low) **You may NOT be eligible if...** - You have had more than a certain number of severe low blood sugar episodes recently - You have significant kidney, liver, or heart problems - You are of childbearing potential (some study parts require men or post-menopausal women) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3938577

Administered Intravenously (IV)

DRUGPlacebo

Administered Intravenously (IV)

DRUGInsulin Degludec

Administered Intravenously (IV)

DRUGInsulin Lispro

Administered Intravenously (IV)

DRUGLY3938577

Administered subcutaneously (SC)

DRUGPlacebo

Administered subcutaneously (SC)

DRUGInsulin Degludec

Administered SC

DRUGBasal Insulin

Administered subcutaneously (SC)

DRUGLispro Prandial Insulin

Administered subcutaneously (SC)


Locations(1)

Profil Institut für Stoffwechselforschung

Neuss, Germany

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NCT06280703


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