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
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