NCT03934307

A Study to Evaluate ALN-AGT01 in Patients With Hypertension

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	ALN-AGT01	ALN-AGT01 will be administered by subcutaneous (SC) injection.
DRUG	ALN-AGT01-Matching Placebo	Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC.
DRUG	Irbesartan	Irbesartan will be administered orally.
DRUG	Irbesartan-Matching Placebo	Irbesartan-matching placebo will be administered orally.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-04-20
• Completion: 2023-01-04
• First posted: 2019-05-01
• Last updated: 2023-01-17

Locations

3 sites across 1 country: United Kingdom