A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
Are participants with T2DM diagnosed greater than 1 year before enrollment,
On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening
Disqualifiers
Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening
Cardiovascular: no significant history of cardiovascular disease (CVD)
Gastrointestinal: have gastroparesis or have undergone gastric surgery
Trial design
Design model
Sequential
Treatments tested in this trial
LY4057996 SC
DrugAdministered SC
LY4057996 IV
DrugAdministered IV
Placebo SC
DrugAdministered SC
Placebo IV
DrugAdministered IV
Degludec SC
DrugAdministered SC
Lispro SC
DrugAdministered SC
Degludec IV
DrugAdministered IV
Pre-study basal insulin SC
DrugAdministered SC
Treatment groups
124 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: LY4057996 Part A (Cohorts A1-A5)Experimental treatment 2 interventions
Group B: Placebo Part A (Cohort A1-A5)Placebo comparator 2 interventions
Group C: LY4057996 Part BExperimental treatment 1 intervention
Group D: LY4057996 Part CExperimental treatment 3 interventions
Group E: Degludec Part A (Cohort A2-A5)Active comparator 2 interventions
Group F: Degludec Part BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number 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)Secondary outcomes
1
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)2
PK: Maximum Concentration (Cmax) of LY4057996
PK: Cmax of LY4057996
Time frame
Baseline to Study Completion (Up to 47 Weeks)3
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)4
PD: AUC of Glucose Infusion Rate (GIR)
PD: AUC of GIR
Time frame
Baseline Up to 10 weeksSponsors and contacts
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Source ClinicalTrials.gov