RecruitingPhase 2NCT07553442

A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran

A Phase 2, Randomized, Double-blind, Placebo-controlled, Single Dose Study of the Efficacy, Pharmacodynamics, and Safety of ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran


Sponsor

Alnylam Pharmaceuticals

Enrollment

93 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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
  • Is an adult participant with a mean seated office SBP of at least 140 mmHg and no more than 170 mmHg
  • Has discontinued all prior antihypertensive medication other than a calcium channel blocker (CCB) and/or thiazide/thiazide-like diuretic (if taking) for at least 3 weeks

Exclusion Criteria2

  • Has known secondary hypertension or serum potassium more than 5 mmol/L
  • Has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m\^2

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Interventions

DRUGALN-AGT01 RVR

ALN-AGT01 RVR will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered SC

DRUGZilebesiran

Zilebesiran will be administered SC


Locations(3)

Clinical Trial Site

Lake Forest, California, United States

Clinical Trial Site

Tampa, Florida, United States

Clinical Trial Site

Savannah, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT07553442


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