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ALN-AGT01 RVR

Phase 2

Hypertension | Small molecule | Cardiovascular |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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07553442A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With ZilebesiranPHASE2 RECRUITING 93Apr 27, 2026Oct 1, 2028May 14, 20263 United States
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Study Endpoints
Primary Endpoints
Part A: Percentage recovery from baseline in serum AGT
Up to Day 4
Part B: Percentage recovery from baseline in mean seated office SBP
At Day 4 and Day 7
Secondary Endpoints
Both Parts: Frequency of Adverse Events (AEs)
Up to 10 months
Part A: Percentage recovery from baseline in serum AGT
Up to Day 7
Part B: Percentage recovery from baseline in serum AGT
At Day 4 and Day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-AGT1 RVREXPERIMENTALParticipants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR.
PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of zilebesiran followed by a single dose of placebo.
Interventions
NameTypeDescription
ALN-AGT01 RVRDRUGALN-AGT01 RVR will be administered subcutaneously (SC)
PlaceboDRUGPlacebo will be administered SC
ZilebesiranDRUGZilebesiran will be administered SC
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Part A: Inclusion Criteria * Is an adult participant with a mean seated office systolic blood pressure (SBP) of at least 130 mmHg and no more than than 170 mmHg * Either not taking antihypertensive medication or on stable therapy with up to 2 antihypertensive medications Part B: Inclusion Criteria...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07553442Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07553442studyFirstPostDate: changed
LOWMay 21, 2026NCT07553442NEW_TRIAL: changed
LOWMay 21, 2026NCT07553442NEW_TRIAL: changed