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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

ALN-4324 for insulin sensitivity in adults with type 2 diabetes

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

Run by Alnylam Pharmaceuticals · NCT07465224 · Data updated 2026-11-12

This study will test whether a single dose of ALN-4324 improves whole-body insulin sensitivity in adults with type 2 diabetes who are on stable metformin therapy.

More Type 2 Diabetes Mellitus (T2DM) trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment24 (estimated)
SponsorAlnylam Pharmaceuticals
Industry-sponsored
Locations1 site (Chula Vista, California)
StatusRecruiting
StartedJanuary 15, 2026
Main results expectedMay 28, 2027
Study endsMay 28, 2027
Registry record updatedOctober 20, 2026
Trial IDNCT07465224 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with confirmed type 2 diabetes, BMI between 25 and 39.9 kg/m^2, HbA1c 6.5% to <10.5%, and on a stable dose of metformin are the intended participants.

Probably not a fit

People using other therapies that alter glucose or insulin metabolism, those with significant comorbidities, or those outside the specified BMI/HbA1c ranges are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial testing a single dose of ALN-4324, an investigational siRNA-based medicine, versus placebo in adults with type 2 diabetes. Participants must meet BMI and HbA1c ranges and remain on a stable dose of metformin. After dosing, whole-body insulin sensitivity is measured and compared between the ALN-4324 and placebo groups. Safety and laboratory measures are monitored to identify any treatment-related effects.

Why it matters

Potential benefit: If successful, ALN-4324 could improve insulin sensitivity and help people with type 2 diabetes achieve better glucose control with fewer additional medications.

How similar studies have gone: RNAi therapies have shown clinical success in other disease areas, but using an siRNA to improve insulin sensitivity in type 2 diabetes is relatively novel with limited prior clinical evidence.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Type 2 Diabetes Mellitus (T2DM) 68Alnylam Pharmaceuticals 18
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.