NCT06945406

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	LY4057996 SC	Administered SC
DRUG	LY4057996 IV	Administered IV
DRUG	Placebo SC	Administered SC
DRUG	Placebo IV	Administered IV
DRUG	Degludec SC	Administered SC
DRUG	Lispro SC	Administered SC
DRUG	Degludec IV	Administered IV
DRUG	Pre-study basal insulin SC	Administered SC

Timeline

• Start date: 2025-05-16
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-04-25
• Last updated: 2026-03-11

Locations

1 site across 1 country: Germany