A Study to Assess the Safety Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure

  • STATUS
    Recruiting
  • End date
    May 24, 2022
  • participants needed
    150
  • sponsor
    Ionis Pharmaceuticals, Inc.
Updated on 26 September 2021
body mass index
calcium
systolic blood pressure
potassium
beta blockers
angiotensin
antihypertensive drugs
angiotensin ii
blood pressure diastolic

Summary

The purpose of this study is to evaluate the effect of IONIS-AGT-LRx compared to placebo on systolic blood pressure (SBP) from baseline to Study Day 85 in uncontrolled hypertensive participants on 3 antihypertensive medications and to evaluate the effect of IONIS-AGT-LRx on SBP, diastolic blood pressure (DBP) and plasma angiotensinogen (AGT) at each scheduled visit in uncontrolled hypertensive participants on 3 antihypertensive medications.

Description

This study will be a Phase 2, double-blind, randomized, placebo-controlled study in up to 150 participants. Participants will be randomized in a 2:1 ratio and will receive a once-weekly subcutaneous (SC) treatment with either IONIS-AGT-LRx or matching placebo. The length of participation in the study will be approximately 29 weeks, which includes an up to 4-week screening period, a 12-week treatment period, and a 13-week post-treatment period.

Details
Condition Vascular Diseases, Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment Placebo, IONIS-AGT-LRx
Clinical Study IdentifierNCT04714320
SponsorIonis Pharmaceuticals, Inc.
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females aged 18-80 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 abstinent, surgically sterile or if engaged in sexual relations with a woman of childbearing potential (WOCBP), a highly effective contraceptive method must be used
Body mass index (BMI) 45.0 kilograms per square meter (kg/m^2)
At screening, the participant must have been on a stable regimen (per Investigator judgement) of 3 or more antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study. The combination of antihypertensive medications must be in the following categories: a) angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), b) beta blocker: c) calcium channel blocker d) non-potassium sparing diuretic, e) alpha-1 blocker f) centrally acting sympatholytic agent or g) direct acting vasodilators (e.g. hydralazine)

Exclusion Criteria

Clinically significant abnormalities in screening laboratory results, medical history according to Investigator judgment
History of secondary hypertension (HTN) including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced 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., minoxidil, diazoxide, renin inhibitors)
Medications that may cause hyperkalemia (e.g., cyclosporine or tacrolimus, pentamidine, trimethoprim-sulfamethoxazole, all heparins)
Use of oral anticoagulants, unless stable for 4 weeks prior to the first dose of study drug and regular monitoring must be performed per clinical practice during the study unless the participant is receiving vitamin K agonists. If the participant is receiving vitamin K antagonists (e.g., warfarin) international normalized ratio (INR) should be in therapeutic range, as established by the Investigator, for 4 weeks prior to the first dose
Chronic administration of NSAIDs or COX-2 inhibitors (except aspirin for cardiovascular disease provided the total daily dose does not exceed 325 mg)
Potassium sparing diuretics (e.g., eplerenone, spironolactone, amiloride, triamterene)
History of bleeding diathesis, coagulopathy, immune thrombocytopenic purpura (ITP), thrombotic cytopenic purpura (TTP), or any qualitative or quantitative platelet defect
Unstable/underlying known cardiovascular disease defined as
Any history of congestive heart failure (New York Heart Association [NYHA] Class III-IV)
Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris 1 year prior to screening
-lead electrocardiogram (ECG) demonstrating a QT interval (corrected using Fridericia's formula [QTcF]) 450 milliseconds (msec) in males and 470 msec in females at screening, or a history or evidence of long QT syndrome
Any hemodynamically unstable atrial or ventricular arrhythmias
Significant uncorrected valvular heart disease
Any history of stroke or transient ischemic attack < 1 year prior to screening
A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
Participant works nighttime shifts (e.g., 11 PM to 7 AM)
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