A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlnylam Pharmaceuticals

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ALN-4324

    Drug

    ALN-4324 will be administered subcutaneously (SC).

  • Placebo

    Drug

    Placebo will be administered SC.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: ALN-4324Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in M-value

M-value is measured as the glucose infusion rate at steady state

Time frame
Baseline up to Month 3

Secondary outcomes

1

Frequency of Adverse Events (AEs)

Time frame
Up to Month 9
2

Change from Baseline in M/I

M/I is measured as the ratio of M-value to insulin concentration \[I\] at steady state

Time frame
Baseline up to Month 6
3

Change from Baseline in M-value

M-value is measured as the glucose infusion rate at steady state

Time frame
Baseline up to Month 6
4

Change from Baseline in Endogenous Glucose Production (EGP)

Both in the basal state and during steady state during the hyperinsulinemic euglycemic clamp (HEC) procedure

Time frame
Baseline up to Month 6

Other outcomes

Sponsors and contacts

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