About this trial
The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is an adult patient with a confirmed diagnosis of T2DM
Has a body mass index (BMI) of ≥23 kg/m² to ≤39.9 kg/m²
Has a hemoglobin A1c (HbA1c) ≥6.5% to <10.5%
Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i)
Disqualifiers
Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results
Receiving therapies known to interfere with glucose or insulin metabolism other than current treatment for T2DM or birth control methods
Trial design
Parallel
Treatments tested in this trial
ALN-4324
DrugALN-4324 will be administered subcutaneously (SC).
Placebo
DrugPlacebo will be administered SC.
Treatment groups
Trial outcomes
Primary outcomes
Change from Baseline in M-value
M-value is measured as the glucose infusion rate at steady state
Secondary outcomes
Frequency of Adverse Events (AEs)
Change from Baseline in M/I
M/I is measured as the ratio of M-value to insulin concentration \[I\] at steady state
Change from Baseline in M-value
M-value is measured as the glucose infusion rate at steady state
Change from Baseline in Endogenous Glucose Production (EGP)
Both in the basal state and during steady state during the hyperinsulinemic euglycemic clamp (HEC) procedure
Sponsors and contacts
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