A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension

Hypertension Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Monthly Subcutaneous Administration of ION904 in Patients With Uncontrolled Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314439
• Other study ID #: ION904-CS2
• Secondary ID: 2022-000140-30
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: December 2023
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of ION904 on plasma angiotensinogen (AGT) in participants with uncontrolled hypertension.

Description:

This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study. It will include up to approximately 48 participants with mild to moderate hypertension who have uncontrolled blood pressure (˃ 130 - ≤ 170 millimeters of mercury [mmHg] systolic) and have been on one or more anti-hypertensive medications for at least one month. Following an up to 4-week screening period, eligible participants will receive multiple doses of ION904 during a 13-week treatment period, followed by a 13-week post-treatment follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 15, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

General Inclusion Criteria:

1. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing = 50 kilograms (kg) at the time of informed consent

2. Body mass index (BMI) = 45.0 kilograms per square meter (kg/m^2) at screening

3. History of uncontrolled hypertension (HTN) on one or more antihypertensive medications without changes in antihypertensive regimen within 4 weeks of screening and will be required to maintain this regimen throughout the Treatment Period

General Exclusion Criteria:

1. History of secondary 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

2. 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 ? 6 months prior to screening

• Any hemodynamically unstable atrial or ventricular arrhythmias

• Significant uncorrected valvular heart disease

• Any history of stroke or transient ischemic attack < 6 months prior to screening

3. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• ION904
ION904 will be administered by SC injection.
• Placebo
Placebo will be administered by SC injection.

Locations

Country	Name	City	State
United States	NY Scientific	Brooklyn	New York
United States	ALL Medical Research, LLC	Cooper City	Florida
United States	Altasciences - Los Angeles	Cypress	California
United States	Juno Research, LLC	Houston	Texas
United States	National Research Institute	Los Angeles	California
United States	Altasciences	Overland Park	Kansas
United States	Progressive Medical Research	Port Orange	Florida
United States	Clinical Trials Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Plasma Angiotensinogen (AGT)		Baseline up to approximately 15 weeks
Secondary	Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)		Baseline up to approximately 15 weeks
Secondary	Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)		Baseline up to approximately 15 weeks