ALN-4324 for insulin sensitivity in adults with type 2 diabetes
A Randomized, Double-blind, Placebo-controlled Study Investigating the Effect of ALN-4324 on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
PHASE2 · Alnylam Pharmaceuticals · NCT07465224
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.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Alnylam Pharmaceuticals (industry) |
| Locations | 1 site (Chula Vista, California) |
| Trial ID | NCT07465224 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chula Vista, California
- Clinical Trial Site — Chula Vista, California, United States (RECRUITING)
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Mellitus, siRNA, RNAi