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ALN-AGT01 RVR

Phase 2

Hypertension | Small molecule | Cardiovascular |Alnylam Pharmaceuticals, Inc.|Last Updated: Aug 14, 2026

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

Clinical trial landscape

ALN-AGT01 RVR · 2 trials · 2 indications

Phase 2 1Phase 1 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
Frequency of Adverse Events (AEs)
Up to 3 months

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.
ALN-AGT01 RVREXPERIMENTALParticipants will be administered a single dose of ALN-AGT01 RVR.

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 StatesCanada
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07553442lastUpdatePostDate: changed
LOWAug 14, 2026NCT07553442lastUpdatePostDate: changed
LOWJul 24, 2026NCT07553442lastUpdatePostDate: changed
LOWJul 24, 2026NCT07553442lastUpdatePostDate: changed
LOWJun 12, 2026NCT07553442lastUpdatePostDate: changed
LOWJun 12, 2026NCT07553442lastUpdatePostDate: changed

Frequently asked questions about ALN-AGT01 RVR

What is ALN-AGT01 RVR used for?

ALN-AGT01 RVR is an investigational drug being studied for use in healthy volunteers and in adult patients with mild to moderate hypertension who have been pretreated with zilebesiran. It is currently in clinical development and is not approved by the FDA.

Who makes ALN-AGT01 RVR?

ALN-AGT01 RVR is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ALNY.

What phase is ALN-AGT01 RVR in?

ALN-AGT01 RVR is in Phase 1 clinical development. One Phase 1 trial in healthy volunteers has been completed, and a Phase 2 trial in patients with hypertension is currently recruiting participants.

What clinical trials is ALN-AGT01 RVR in?

ALN-AGT01 RVR has been studied in two clinical trials. NCT06675565 is a completed Phase 1 study in healthy volunteers in Canada. NCT07553442 is a recruiting Phase 2 study in patients with mild to moderate hypertension in the United States.

Is ALN-AGT01 RVR the same as zilebesiran?

No, ALN-AGT01 RVR is not the same as zilebesiran. It is being studied in patients who have been pretreated with zilebesiran, indicating that the two drugs are distinct and used in sequence in the clinical trial setting.