A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension

Summary

The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.

Timeline

Start

2021-07-07

Primary completion

2023-04-04

Completion

2024-12-05

Outcome

Met primary endpoint

registry Placebo vs Zilebesiran 300 mg Q6M and Q3M; p <0.0001; Difference in LS Mean -16.7 (95% CI -21.2 to -12.3) NCT04936035 ↗

registry Placebo vs Zilebesiran 600 mg Q6M; p <0.0001; Difference in LS Mean -15.7 (95% CI -20.8 to -10.6) NCT04936035 ↗

release “Zilebesiran Met Primary Endpoint Demonstrating Greater than 15 mmHg Reduction of Systolic Blood Pressure at Three Months of Treatment” alnylam.com ↗

release “KARDIA-1 [NCT04936035] Evaluated zilebesiran monotherapy in people with mild to moderate hypertension. Met primary endpoint.” roche.com ↗

release “KARDIA-1 [NCT04936035] Evaluated zilebesiran monotherapy in people with mild to moderate hypertension. Met primary endpoint” gene.com ↗

Publications

• Bakris GL, Saxena M, Gupta A, Chalhoub F, Lee J, Stiglitz D, Makarova N, Goyal N, Guo W, Zappe D, Desai AS; KARDIA-1 Study Group. RNA Interference With Zilebesiran for Mild to Moderate Hypertension: The KARDIA-1 Randomized Clinical Trial. JAMA. 2024 Mar 5;331(9):740-749. doi: 10.1001/jama.2024.0728.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zilebesiran	Unknown	150 mg	Subcutaneous
Subject	Zilebesiran	Unknown	300 mg	Subcutaneous
Subject	Zilebesiran	Unknown	600 mg	Subcutaneous

Indications