NCT05314439

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

March 29, 2022

Last Update Submit

December 20, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Plasma Angiotensinogen (AGT)

    Baseline up to approximately 15 weeks

Secondary Outcomes (2)

  • Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)

    Baseline up to approximately 15 weeks

  • Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)

    Baseline up to approximately 15 weeks

Study Arms (2)

ION904

EXPERIMENTAL

Up to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection.

Drug: ION904

Placebo

PLACEBO COMPARATOR

Up to 4 monthly doses of placebo will be administered by SC injection.

Drug: Placebo

Interventions

ION904DRUG

ION904 will be administered by SC injection.

ION904
PlaceboDRUG

Placebo will be administered by SC injection.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2) at screening
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Altasciences - Los Angeles

Cypress, California, 90630, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Clinical Trials Research

Sacramento, California, 95821, United States

Location

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Altasciences

Overland Park, Kansas, 66212, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Juno Research, LLC

Houston, Texas, 77040, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

April 29, 2022

Primary Completion

January 31, 2023

Study Completion

February 15, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(8)