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
Alnylam Pharmaceuticals
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.
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
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 SiteLake Forest, California
- Clinical Trial SiteTampa, Florida
- Clinical Trial SiteSavannah, Georgia