Recruiting
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
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.
ClinicalTrials.gov IDNCT07553442
PhasePHASE2
Enrollment93
SponsorAlnylam Pharmaceuticals
Age18 Years – 75 Years
SexALL
Conditions studied
Hypertension
About this study
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.
Interventions
- Drug: ALN-AGT01 RVR — ALN-AGT01 RVR will be administered subcutaneously (SC)
- Drug: Placebo — Placebo will be administered SC
- Drug: Zilebesiran — Zilebesiran will be administered SC
Primary outcomes
- 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)
Eligibility information
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
Study 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
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.