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NCT07553442PHASE2Recruiting

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

Alnylam Pharmaceuticals

Start Date

4/27/2026

Completion Date

10/1/2028

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.

Detailed Description

This study will be conducted in 2 parts: * Part A: Single dose (SD), dose-ranging part in adults with mild to moderate hypertension. * Part B: SD in adults with mild to moderate hypertension.

Eligibility Criteria

Age Range: 18 years to 75 years

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 * 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 Both Parts: Exclusion Criteria * 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 Note: other protocol defined inclusion / exclusion criteria apply

Interventions

DRUG

ALN-AGT01 RVR

DRUG

Placebo

DRUG

Zilebesiran

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Conditions

Hypertension

Locations

Clinical Trial Site

Lake Forest, California 92630

United States

Clinical Trial Site

Tampa, Florida 33613

United States

Clinical Trial Site

Savannah, Georgia 31405

United States