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NCT Number: NCT07465224

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site

Chula Vista, California, 91911, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-4324

Drug

ALN-4324 will be administered subcutaneously (SC).

Placebo

Drug

Placebo will be administered SC.

Primary outcomes

  1. Change from Baseline in M-value

    Time frame: Baseline up to Month 3

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

Secondary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: Up to Month 9

  2. Change from Baseline in M/I

    Time frame: Baseline up to Month 6

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

  3. Change from Baseline in M-value

    Time frame: Baseline up to Month 6

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

  4. Change from Baseline in Endogenous Glucose Production (EGP)

    Time frame: Baseline up to Month 6

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

  5. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline up to Month 6

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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