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

Phase 2

Completed

• Conditions: Mild Hypertension
• Interventions: Drug: Placebo; Drug: ISIS 757456

• Registration Number: NCT03714776
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2019-01-03
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Disposition First Submitted: 2020-11-12
• Results First Submitted: 2022-11-12
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-13
• Disposition First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Results First Posted: 2023-01-06
• Disposition First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo matching solution injected subcutaneously (SC) once weekly for up to 6 weeks and an additional loading dose on Day 3.
ISIS 757456 80 mg	ISIS 757456	ISIS 757456 80 mg injected SC once weekly for up to 6 weeks and an additional loading dose of 80 mg on Day 3.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 43 (Week 7) Compared to Placebo	Baseline, Week 7

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Plasma AGT at Days 3, 8, 15, 22, 29 and 36	Baseline, Days 3, 8, 15, 22, 29, and 36
Change From Baseline in the In-clinic Systolic Blood Pressure (SBP) at Days 3, 8, 15, 22, 29, and 36	Baseline, Days 3, 8, 15, 22, 29, and 36

Trial Locations

Locations (6)

Ohio Clinical Research - Lyndhurst; 🇺🇸 Lyndhurst, Ohio, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Midwest Institute for Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

York Clinical Research LLC; 🇺🇸 Norfolk, Virginia, United States

Juno Research, LLC - Northwest Site; 🇺🇸 Houston, Texas, United States