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

Phase 2RecruitingNCT07465224

Alnylam Pharmaceuticals24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

ALN-4324DRUG

ALN-4324 will be administered subcutaneously (SC).

PlaceboDRUG

Placebo will be administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is an adult patient with a confirmed diagnosis of T2DM * Has a body mass index (BMI) of ≥23 kg/m\^2 to ≤39.9 kg/m\^2 * 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) Exclusion Criteria: * 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 Note: other protocol defined inclusion/exclusion criteria apply

Locations (1)

Clinical Trial Site

Chula Vista, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Frequency of Adverse Events (AEs)

Time frame: Up to Month 9

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

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

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

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline up to Month 6

Central Contacts

Alnylam Clinical Trial Information Line

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com

Data from ClinicalTrials.gov

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