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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
124
Administered SC
Administered IV
Administered SC
Administered IV
Administered SC
Administered SC
Administered IV
Administered SC
Profil Institut für Stoffwechselforschung
Neuss, Germany
RECRUITINGNumber of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline to Study Completion (Up to 47 Weeks)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996
PK: AUC of LY4057996
Time frame: Baseline to Study Completion (Up to 47 Weeks)
PK: Maximum Concentration (Cmax) of LY4057996
PK: Cmax of LY4057996
Time frame: Baseline to Study Completion (Up to 47 Weeks)
Pharmacodynamic (PD): Change from Baseline in Fasting Glucose
PD: Change from Baseline in Fasting Glucose
Time frame: Baseline to Study Completion (Up to 47 Weeks)
PD: AUC of Glucose Infusion Rate (GIR)
PD: AUC of GIR
Time frame: Baseline Up to 10 weeks
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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