NCT04083222

A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx

A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously for 8 Weeks to Hypertensive Subjects With Uncontrolled Blood Pressure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effect of ISIS 757456 (IONIS-AGT-LRx) on plasma angiotensinogen (AGT) and systolic blood pressure (SBP) in uncontrolled hypertensive participants who were on two to three antihypertensive medications.

Detailed description

This study was a Phase 2, double-blind, randomized, placebo-controlled study in 26 participants. Participants were randomized in a 2:1 ratio and received a once-weekly subcutaneous (SC) treatment with either IONIS-AGT-LRx or placebo, with an additional loading dose administered on Study Day 3. The treatment lasted for 8 weeks and the post-treatment period lasted for 13 weeks.

Conditions

• Hypertension

Interventions

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

Timeline

• Start date: 2019-11-13
• Primary completion: 2020-07-20
• Completion: 2020-07-20
• First posted: 2019-09-10
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study