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IONIS-AGT-LRx

Phase 2

Chronic Heart Failure With Reduced Ejection Fraction | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Feb 18, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

IONIS-AGT-LRx · 2 trials · 2 indications

Phase 2 2
NCT04836182A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection FractionChronic Heart Failure With Reduced Ejection Fraction
COMPLETED72 Analytics
NCT04714320A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood PressureHypertension
COMPLETED160 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Chronic Heart Failure With Reduced Ejection FractionUnlock trial analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Hypertensive Participants With Uncontrolled Blood Pressure
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change in Plasma AGT Concentration From Baseline to Study Day 85
Baseline to Day 85
Change From Baseline in Seated Automated Office SBP to Day 85
Baseline to Day 85

Secondary Endpoints

Absolute Level of Plasma AGT
Baseline to Day 169
Change in Plasma AGT From Baseline to Each Scheduled, Post-Baseline Visit
Baseline to Day 169
Percent Change in Plasma AGT From Baseline to Each Scheduled, Post-Baseline Visit
Baseline to Day 169
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IONIS-AGT-LRxEXPERIMENTALIONIS-AGT-LRX by subcutaneous injection once-weekly
PlaceboPLACEBO_COMPARATORMatching placebo by subcutaneous injection once-weekly
Pooled PlaceboPLACEBO_COMPARATORParticipants received ISIS 757456 matching placebo subcutaneously once weekly for 12 weeks.
IONIS-AGT-LRx 80 mgEXPERIMENTALParticipants received ISIS 757456 80 milligrams (mg), subcutaneous (SC) injection, once weekly for 12 weeks.
IONIS-AGT-LRx 120 mgEXPERIMENTALParticipants received ISIS 757456 120 mg, SC injection, once weekly for 12 weeks.

Interventions

NameTypeDescription
IONIS-AGT-LRxDRUGMultiple doses of IONIS-AGT-LRx will be administered by SC injection.
PlaceboDRUGIONIS-AGT-LRx-matching placebo will be administered by SC injection.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: 1. Females must be non-pregnant and non-lactating and of non- childbearing potential. 2. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she must be willing to use a highly effective contraceptive...

Countries:United StatesHungaryPolandCanada
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Frequently asked questions about IONIS-AGT-LRx

What is IONIS-AGT-LRx used for?

IONIS-AGT-LRx is an investigational drug being studied for hypertension and chronic heart failure with reduced ejection fraction. It has been evaluated in clinical trials involving healthy volunteers, hypertensive participants with uncontrolled blood pressure, and participants with chronic heart failure with reduced ejection fraction. The drug is in Phase 2 development for these cardiovascular conditions.

How does IONIS-AGT-LRx work?

IONIS-AGT-LRx targets angiotensinogen, a protein involved in blood pressure regulation. By reducing angiotensinogen levels, the drug aims to lower blood pressure. This mechanism is being investigated as a potential treatment for hypertension and chronic heart failure with reduced ejection fraction.

Who makes IONIS-AGT-LRx?

IONIS-AGT-LRx is developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in cardiovascular conditions.

What phase is IONIS-AGT-LRx in?

IONIS-AGT-LRx is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including studies in healthy volunteers, hypertensive participants, and participants with chronic heart failure with reduced ejection fraction. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials has IONIS-AGT-LRx been in?

IONIS-AGT-LRx has been studied in three completed clinical trials. NCT03101878 was a Phase 1 study in healthy volunteers. NCT04714320 was a Phase 2 study in hypertensive participants with uncontrolled blood pressure. NCT04836182 was a Phase 2 study in participants with chronic heart failure with reduced ejection fraction.

Is IONIS-AGT-LRx the same as Ionis AGT-LRx?

Yes, IONIS-AGT-LRx is also referred to as Ionis AGT-LRx. The drug is developed by Ionis Pharmaceuticals and has been studied under both names in clinical trials. It targets angiotensinogen for the treatment of hypertension and chronic heart failure with reduced ejection fraction.