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ALN-4324

Phase 2

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07465224A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes MellitusPHASE2 RECRUITING 40Jan 15, 2026May 28, 2027May 14, 20261 United States
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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

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.
Interventions
NameTypeDescription
ALN-4324DRUGALN-4324 will be administered subcutaneously (SC).
PlaceboDRUGPlacebo will be administered SC.
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Eligibility Criteria
Age Range18 Years — 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 States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07465224primaryCompletionDate: changed
LOWMay 24, 2026NCT07465224studyFirstPostDate: changed