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Recruiting NCT07465224

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

Phase II Interventional Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALN-4324, Placebo.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled Study Investigating the Effect of ALN-4324 on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

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

Interventions

  • Drug ALN-4324
    ALN-4324 will be administered subcutaneously (SC).
  • Drug Placebo
    Placebo will be administered SC.

Primary outcome measures

  • Change from Baseline in M-value [Time frame: Baseline up to Month 3]
Secondary outcome measures (5)
  • Frequency of Adverse Events (AEs) [Time frame: Up to Month 9]
  • Change from Baseline in M/I [Time frame: Baseline up to Month 6]
  • Change from Baseline in M-value [Time frame: Baseline up to Month 6]
  • Change from Baseline in Endogenous Glucose Production (EGP) [Time frame: Baseline up to Month 6]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline up to Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Clinical Trial Site — Chula Vista

Identifiers

NCT: NCT07465224 · ALN-4324-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗