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ALN-4324

Phase 2

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Alnylam Pharmaceuticals, Inc.|Last Updated: Jun 12, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical trial landscape

ALN-4324 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07465224A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)
RECRUITING40 Analytics
PHASE2RECRUITING
A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)Unlock trial analytics
Study Endpoints
Primary Endpoints
Change from Baseline in M-value
Baseline up to Month 3

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

Part A: Frequency of Adverse Events (AEs)
Up to 9 months
Part B: Frequency of Adverse Events
Up to 12 months
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-4324EXPERIMENTALParticipants will be administered a single dose of ALN-4324.
PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo.
Part A: ALN-4324EXPERIMENTALParticipants will be administered a single dose of ALN-4324.
Part A: PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo.
Part B: ALN-4324EXPERIMENTALParticipants will be administered multiple doses of ALN-4324
Part B: PlaceboPLACEBO_COMPARATORParticipants will be administered multiple doses of placebo
Interventions
NameTypeDescription
ALN-4324DRUGALN-4324 will be administered subcutaneously (SC).
PlaceboDRUGPlacebo will be administered SC.
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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,...

Countries:United StatesArgentinaCanadaChileGermanyPoland
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Recent Changes (Last 90 Days)
LOWJun 12, 2026NCT06845202lastUpdatePostDate: changed
LOWJun 12, 2026NCT07465224lastUpdatePostDate: changed
LOWJun 12, 2026NCT06845202lastUpdatePostDate: changed
LOWJun 12, 2026NCT07465224lastUpdatePostDate: changed
LOWMay 26, 2026NCT06845202primaryCompletionDate: changed
LOWMay 26, 2026NCT07465224primaryCompletionDate: changed
LOWMay 24, 2026NCT06845202studyFirstPostDate: changed
LOWMay 24, 2026NCT07465224studyFirstPostDate: changed