RecruitingPhase 1NCT06945406

A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes


Sponsor

Eli Lilly and Company

Enrollment

124 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it. The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental insulin called LY4057996 to see if it is safe and how the body processes it. The study includes healthy volunteers, people with type 2 diabetes, and people with type 1 diabetes. **You may be eligible if...** - You are generally healthy (for the healthy volunteer part) - You have had type 2 diabetes for more than 1 year and your blood sugar control (HbA1c) is between 6.5% and 9.5% - You are on basal insulin therapy (long-acting insulin like glargine or degludec) for at least 6 months at a dose over 10 units per day - You have type 1 diabetes (for the type 1 diabetes part of the study) **You may NOT be eligible if...** - You have significant kidney, liver, or heart problems - You are pregnant or breastfeeding - You have had a recent serious medical event - You are on medications that could interfere with the study drug 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

DRUGLY4057996 SC

Administered SC

DRUGLY4057996 IV

Administered IV

DRUGPlacebo SC

Administered SC

DRUGPlacebo IV

Administered IV

DRUGDegludec SC

Administered SC

DRUGLispro SC

Administered SC

DRUGDegludec IV

Administered IV

DRUGPre-study basal insulin SC

Administered SC


Locations(1)

Profil Institut für Stoffwechselforschung

Neuss, Germany

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NCT06945406


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