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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
118
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered Intravenously (IV)
Administered subcutaneously (SC)
Administered subcutaneously (SC)
Administered SC
Administered subcutaneously (SC)
Administered subcutaneously (SC)
Profil Institut für Stoffwechselforschung
Neuss, Germany
RECRUITINGPart A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration.
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Baseline up to Approximately Week 11
Part B and D: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration.
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Time frame: Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time frame: Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time frame: Baseline up to Week 10
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577 for intravenous administration
Time frame: Predose on day 1 up to week 13 post dose
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
Part C: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
Part D: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
PK: AUC of LY3938577 for SC administration
Time frame: Predose on day 1 up to week 13 post dose
Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577
PK: Cmax of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577
PK: Cmax of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
Part C: PK: Concentration of LY3938577
Time frame: Predose on day 1 up to week 13 post dose
Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577
Measured at different glucose levels in participants with T1DM
Time frame: Predose up to day 14 post dose
Part C: PD: Glucose infusion rate (GIR) of LY3938577
Measured at different glucose levels in participants with T1DM
Time frame: Predose up to day 14 post dose
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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