Recruiting
Phase 2

ALN-4324

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07465224

Conditions

Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALN-4324

Placebo

Study Details

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)

Study ID

NCT07465224

Start date

Jan 15, 2026

Status verified date

Aug, 2026

Completion date

May 28, 2027

Anticipated

Primary completion date

May 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-4324

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

placebo comparator: Placebo

Participants will be administered a single dose of placebo.

Interventions

ALN-4324

ALN-4324 will be administered subcutaneously (SC).

Placebo

Placebo will be administered SC.

Primary outcome measure

  • Change from Baseline in M-value [ Time Frame: Baseline up to Month 3 ]

Central Contacts and Locations

Central contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

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

Locations

Clinical Trial Site

Recruiting

Chula Vista, California, United States, 91911

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • siRNA
  • RNAi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-08-12.