NCT04936035

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

A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients With Mild-to-Moderate Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo administered by SC injection
DRUG	ALN-AGT01	ALN-AGT01 administered by SC injection

Timeline

• Start date: 2021-07-07
• Primary completion: 2023-04-04
• Completion: 2024-12-05
• First posted: 2021-06-23
• Last updated: 2025-12-23
• Results posted: 2024-12-27

Locations

75 sites across 5 countries: United States, Canada, Puerto Rico, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study