At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Dose and Active Comparator-Controlled Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-AGT01 in Patients With Hypertension
In Brief
A Phase 1 clinical trial evaluating ALN-AGT01, ALN-AGT01-Matching Placebo, and 2 other interventions for Hypertension. Completed, enrolled 124 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 (zilebesiran) in participants with hypertension. The study will be conducted in 4 parts: Part A will be a single ascending dose (SAD) phase in hypertensive participants, Part B will be a single dose (SD) phase in hypertensive participants with controlled salt intake, Part D will be a MD phase in hypertensive participants who are obese, and Part E will be an open-label SD phase with co-administration of irbesartan in hypertensive patients.
Study Details
Timeline
Interventions
ALN-AGT01 will be administered by subcutaneous (SC) injection.
Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC.
Irbesartan will be administered orally.
Irbesartan-matching placebo will be administered orally.