Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT06945406

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

Led by Eli Lilly and Company · Updated on 2026-03-11

124

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For healthy participants: must be overtly healthy based on medical evaluation including history, physical exam, lab tests, and heart screening
  • For Type 2 Diabetes participants: diagnosed more than 1 year ago
  • For Type 2 Diabetes participants in Cohort 5: on basal insulin therapy (insulin glargine, detemir, or degludec) over 10 units per day for at least 6 months
  • HbA1c between 6.5% and 9.5% for Type 2 Diabetes participants at screening
  • For Type 1 Diabetes participants: have the disease for at least 1 year with fasting C-peptide ≤0.20 nmol/L or non-fasting C-peptide ≤0.30 nmol/L
  • HbA1c between 6% and 8.5% for Type 1 Diabetes participants at screening
  • Blood pressure less than 140/90 mmHg for healthy participants or less than 150/90 mmHg for diabetes participants
  • Pulse rate less than 90 bpm (supine)
  • No hypoglycemia unawareness for all diabetes participants
Not Eligible

You will not qualify if you...

  • More than 1 emergency room visit or hospitalization for poor glucose control in the 6 months before screening
  • Any severe hypoglycemia episodes or hypoglycemia unawareness in the 6 months before screening
  • Significant history of cardiovascular disease
  • Gastrointestinal conditions like gastroparesis or history of gastric surgery
  • Acute or chronic hepatitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Profil Institut für Stoffwechselforschung

Neuss, Germany, 41460

Actively Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

6

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