NCT03714776

A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure

A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Subjects With Controlled Blood Pressure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2, double-blind, randomized, placebo-controlled study of IONIS-AGT-LRx conducted in mild hypertensive participants.

Detailed description

Participants were randomized in a 2:1 ratio to receive a once-weekly subcutaneous treatment and an additional loading dose on Study Day 3 with either IONIS-AGT-LRx or placebo for 6 weeks. All participants completed a 13-week Post-Treatment Period.

Conditions

• Mild Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching solution administered as SC injection.
DRUG	ISIS 757456	Administered as SC injection.

Timeline

• Start date: 2019-01-03
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2018-10-22
• Last updated: 2023-01-06
• Results posted: 2023-01-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study