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Clinical Trial Details

Trial ID: L4767
Source ID: NCT06280703
Associated Drug: Ly3938577
Title: A Study of LY3938577 in Healthy Participants and Participants with Type 1 Diabetes Mellitus (T1DM)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Healthy|Type 1 Diabetes Mellitus
Interventions: DRUG: LY3938577|DRUG: Placebo|DRUG: Insulin Degludec|DRUG: Insulin Lispro|DRUG: LY3938577|DRUG: Placebo|DRUG: insulin degludec
Outcome Measures: Primary: Part 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., Baseline up to Approximately Week 11|Part B: 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., Baseline up to Week 10|Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Baseline up to Approximately Week 11|Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Baseline up to Week 10|Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, Baseline up to Approximately Week 11|Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters, 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, 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, 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, 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 for SC administration LY3938577, Predose on day 1 up to week 13 post dose|Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577, PK: Cmax of LY3938577, Predose on day 1 up to week 13 post dose|Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577, PK: Cmax of LY3938577, Predose on day 1 up to week 13 post dose|Part C: PK: Concentration of LY3938577, Predose on day 1 up to week 13 post dose | Secondary: Part B: Pharmacodynamic (PD): Area under the glucose infusion rate curve (GIR AUC) of LY3938577, Measured at different glucose levels in participants with T1DM, 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, Predose up to day 14 post dose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-15
Completion Date: 2025-07
Results First Posted:
Last Update Posted: 2025-03-12
Locations: Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT06280703