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

May 12, 2026 updated by: Alnylam Pharmaceuticals

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is an adult patient with a confirmed diagnosis of T2DM
  • Has a body mass index (BMI) of ≥25 kg/m^2 and <39.9 kg/m^2
  • Has a hemoglobin A1c (HbA1c) ≥6.5% to <10.5%
  • Is on a stable dose of metformin

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will be administered a single dose of placebo.
Drug: Placebo
Placebo will be administered SC.
Experimental: ALN-4324
Participants will be administered a single dose of ALN-4324.
Drug: ALN-4324
ALN-4324 will be administered subcutaneously (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events (AEs)
Time Frame: Up to Month 9
Up to Month 9
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
Baseline up to Month 6
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
Baseline up to Month 6
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
Baseline up to Month 6
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline up to Month 6
Baseline up to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

  • Study Director: Medical Director, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

May 28, 2027

Study Completion (Estimated)

May 28, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALN-4324-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.

Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.

Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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