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A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04083222•Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females aged 18-75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
•Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
•Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), the participant or participant's non-pregnant female partner must be using a highly effective contraceptive method
•Body mass index (BMI) ≤ 35.0 kg/square meter (m\^2)
•Participant must have been diagnosed with essential hypertension for a minimum of 3 months prior to screening
•At screening, the participant must have been on a stable regimen of 2 to 3 antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study, using either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), as well as 1 or 2 additional antihypertensive medications in the following categories: beta blocker, acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, pindolol, calcium channel blocker or, non-potassium sparing diuretic

Exclusion Criteria

•Clinically significant abnormalities in medical history, screening laboratory results, or physical examination that would render the participant unsuitable for inclusion
•History of secondary hypertension (HTN)
•The use of the following at time of screening and during the course of the study:
•Other medications for the treatment of HTN (e.g., clonidine, guanfacine, guanabenz, alpha-methyldopa, hydralazine, minoxidil, diazoxide, renin inhibitors)
•Medications that may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins)
•Oral or SC anticoagulants (e.g., warfarin, rivaroxaban, apixaban, heparin, lovenox)
•Organic nitrate preparations (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, or pentaerythritol)
•Phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
•Potassium-sparing diuretics (e.g., eplerenone, spironolactone, amiloride, triamterene)
•Unstable/underlying cardiovascular disease defined as:
+5 more criteria

Locations (9)

Central Alabama Research

Birmingham, Alabama, United States

National Research Institute - Wilshire

Los Angeles, California, United States

Orange County Research Center

Tustin, California, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Ohio Clinical Research - Lyndhurst

Lyndhurst, Ohio, United States

Juno Research, LLC

Houston, Texas, United States

York Clinical Research LLC

Norfolk, Virginia, United States

Key Dates

Start Date

November 13, 2019

Primary Completion Date

July 20, 2020

Completion Date

July 20, 2020

Last Updated

January 18, 2023

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Placebo

DRUG

ISIS 757456

DRUG

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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