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

NCT07465224 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ALN-4324-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

siRNA; RNAi

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in M-value

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

  Baseline up to Month 3

Secondary Outcomes (5)

• Frequency of Adverse Events (AEs)

  Up to Month 9

• Change from Baseline in M/I

  Baseline up to Month 6

• Change from Baseline in M-value

  Baseline up to Month 6

• Change from Baseline in Endogenous Glucose Production (EGP)

  Baseline up to Month 6

• Change from Baseline in Hemoglobin A1c (HbA1c)

  Baseline up to Month 6

Study Arms (2)

ALN-4324

EXPERIMENTAL

Participants will be administered a single dose of ALN-4324.

Drug: ALN-4324

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo.

Drug: Placebo

Interventions

ALN-4324 DRUG

ALN-4324 will be administered subcutaneously (SC).

ALN-4324

Placebo DRUG

Placebo will be administered SC.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (1)

Clinical Trial Site

Chula Vista, California, 91911, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)