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ALN-AGT01 RVR

Phase 2

Hypertension | Small molecule | Cardiovascular |Alnylam Pharmaceuticals, Inc.|Trials Updated: Oct 8, 2026

ALN-AGT01 RVR development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Nov 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

ALN-AGT01 RVR clinical trials

ALN-AGT01 RVR · 1 trial · 1 indication

Phase 2 1
NCT07553442A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With ZilebesiranHypertension
RECRUITING93 Analytics
PHASE2RECRUITING
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
HypertensionUnlock trial analytics

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 to 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)

LOWOct 8, 2026NCT07553442lastUpdatePostDate: changed
LOWOct 8, 2026NCT07553442lastUpdatePostDate: changed
LOWSep 15, 2026NCT07553442lastUpdatePostDate: changed
LOWSep 15, 2026NCT07553442lastUpdatePostDate: changed
LOWSep 15, 2026NCT07553442lastUpdatePostDate: changed
LOWAug 14, 2026NCT07553442lastUpdatePostDate: changed
LOWAug 14, 2026NCT07553442lastUpdatePostDate: changed
LOWJul 24, 2026NCT07553442lastUpdatePostDate: changed
LOWJul 24, 2026NCT07553442lastUpdatePostDate: changed

Frequently asked questions about ALN-AGT01 RVR

What is ALN-AGT01 RVR?

ALN-AGT01 RVR is an investigational medicine being developed by Alnylam Pharmaceuticals, Inc. (ticker ALNY) for the treatment of hypertension. It is currently in Phase 2 clinical development and is being studied in adults with mild to moderate hypertension. It has not been approved by the FDA.

What is ALN-AGT01 RVR used for?

ALN-AGT01 RVR is being studied for the treatment of hypertension, specifically mild to moderate hypertension in adults. The Phase 2 trial enrolls patients aged 18 years and older in the United States. It is an investigational therapy and is not approved for any indication.

Who makes ALN-AGT01 RVR?

ALN-AGT01 RVR is being developed by Alnylam Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ALNY. Alnylam is the sponsor of the ongoing Phase 2 study of the drug in hypertension.

What phase is ALN-AGT01 RVR in?

ALN-AGT01 RVR is in Phase 2 clinical development. One Phase 2 trial is currently recruiting, and no trials of the drug have been completed. The program has not reached regulatory approval, so ALN-AGT01 RVR remains an investigational therapy for hypertension.

What clinical trials is ALN-AGT01 RVR in?

ALN-AGT01 RVR is being evaluated in the Phase 2 trial NCT07553442, titled A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran. The trial is recruiting in the United States, is placebo-controlled and double-blind, and plans to enroll 93 participants.

Is ALN-AGT01 RVR FDA approved?

No. ALN-AGT01 RVR is an investigational drug in Phase 2 clinical development and has not been approved by the FDA. It is being studied in a single recruiting Phase 2 trial in adults with mild to moderate hypertension.