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Clinical Trial Details

Trial ID: L6922
Source ID: NCT05407961
Associated Drug: Ly3532226
Title: A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: LY3532226|DRUG: Placebo|DRUG: Dulaglutide
Outcome Measures: Primary: Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module, Baseline up to Week 16|Part B: Change from Baseline in Total Clamp Disposition Index (cDI), Change from Baseline in Total cDI, Baseline up to Week 12 | Secondary: Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226, PK: Cmax of LY3532226, Predose on Day 1 through Week 16|Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226, PK: AUC of LY3532226, Predose on Day 1 through Week 16|Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp, Change from Baseline in ISR from hyperglycaemic clamp, Baseline through Week 12|Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp, Change from Baseline in β-cell GS from hyperglycaemic clamp, Baseline through Week 12|Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value, Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value, Baseline through Week 12|Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT), Change from Baseline in Fasting and Post meal Glucose during sMMTT, Baseline through Week 16|Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c), Change from Baseline in HbA1c, Baseline through Week 16|Part A & B: Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT, Change from Baseline in Glucagon Concentration at Fasting and Post meal during sMMTT, Baseline through Week 16
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 90
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-06-07
Completion Date: 2024-01-12
Results First Posted:
Last Update Posted: 2024-03-29
Locations: Profil Institut für Stoffwechselforschung, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT05407961