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

StatusRecruiting
PhasePhase 2
Started2026-01-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 40% 40 → 24 participants
See other at-risk trials from Alnylam Pharmaceuticals

Amendment history

2026-08-11
minor
Study Status v5
Re-verified, no change to tracked fields
2026-07-22
critical
Study Status, Study Design, Eligibility v4
Enrollment reduced: 40 → 24 participants
Eligibility criteria+95 characters
Inclusion Criteria: Is an adult patient with a confirmed diagnosis of T2DM Has a body mass index (BMI) of ≥2523 kg/m^2 andto <≤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 concomit [...]
2026-06-10
minor
3 amendments v1-v3
3 re-verifications since 2026-04-16, no change to tracked fields
2026-03-06
minor
Original filing
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
Trial Details
NCT Number NCT07465224
Lead Sponsor Alnylam Pharmaceuticals
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 24 participants
Start Date 2026-01-15
Primary Completion 2027-05-28 (estimated)
Study Completion 2027-05-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-16