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ISIS 757456

Phase 2

Hypertension | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 18, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

ISIS 757456 · 2 trials · 2 indications

Phase 2 2
NCT04083222A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRxHypertension
COMPLETED26 Analytics
NCT03714776A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood PressureMild Hypertension
COMPLETED25 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx
HypertensionUnlock trial analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Participants With Controlled Blood Pressure
Mild HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 57 Compared to Placebo
Baseline up to Day 57 (start of Week 9)

The baseline for plasma AGT was defined as the average of all values prior to the first dose of study drug.

Percent Change From Baseline in Plasma Angiotensinogen (AGT) at Day 43 (Week 7) Compared to Placebo
Baseline, Week 7

Secondary Endpoints

Change From Baseline in Systolic Blood Pressure (SBP) at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141
Absolute Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 120, and 141
Percent Change From Baseline in Plasma AGT at Each Scheduled, Post-Baseline Visit
Baseline, Days 3, 8, 15, 22, 29, 36, 43, 50, 64, 78, 92, 120, and 141
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received ISIS 757456-matching placebo, subcutaneous (SC) injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
ISIS 757456EXPERIMENTALParticipants received ISIS 757456 80 mg, SC injection, once-weekly for 8 weeks and an additional loading dose on Day 3.
ISIS 757456 80 mgEXPERIMENTALISIS 757456 80 mg injected SC once weekly for up to 6 weeks and an additional loading dose of 80 mg on Day 3.

Interventions

NameTypeDescription
PlaceboDRUGISIS 757456-matching placebo solution administered as SC injection.
ISIS 757456DRUGISIS 757456 administered as SC injection.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

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 r...

Countries:United States
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Frequently asked questions about ISIS 757456

What is ISIS 757456 used for?

ISIS 757456, also known as IONIS-AGT-LRx, is an investigational antisense inhibitor being developed for the treatment of mild hypertension and hypertension. It is administered subcutaneously and is intended for hypertensive participants with controlled blood pressure. The drug is currently in Phase 2 clinical development.

What does ISIS 757456 target?

ISIS 757456 targets angiotensinogen (AGT), as indicated by its alternative name IONIS-AGT-LRx. It is an antisense inhibitor designed to reduce the production of angiotensinogen, a protein involved in blood pressure regulation. By targeting AGT, the drug aims to lower blood pressure in patients with hypertension.

Who makes ISIS 757456?

ISIS 757456 is developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker IONS. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this antisense inhibitor in patients with hypertension.

What phase is ISIS 757456 in?

ISIS 757456 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, both focusing on patients with hypertension, including those with mild hypertension and controlled blood pressure.

What clinical trials is ISIS 757456 in?

ISIS 757456 has been studied in two completed Phase 2 clinical trials. The first, NCT03714776, assessed the drug in 25 participants with mild hypertension. The second, NCT04083222, enrolled 26 participants with hypertension. Both trials were conducted in the United States and were randomized, double-blind, and placebo-controlled.

Is ISIS 757456 the same as IONIS-AGT-LRx?

Yes, ISIS 757456 is the same as IONIS-AGT-LRx. The drug is referred to by both names in clinical trial records. IONIS-AGT-LRx is the more descriptive name, indicating its target angiotensinogen and its antisense mechanism. Both names refer to the same investigational compound developed by Ionis Pharmaceuticals.