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ISIS 757456

Phase 2

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

ISIS 757456 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Oct 2018

ISIS 757456 target and mechanism

ModalitySmall molecule

Also known as IONIS-AGT-LRx

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment51

FDA Designations

No designations recorded

ISIS 757456 clinical trials

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 studied for the treatment of hypertension, including mild hypertension. It is administered subcutaneously and is currently in Phase 2 clinical development for these cardiovascular conditions.

Who makes ISIS 757456?

ISIS 757456 is being 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 safety, tolerability, and efficacy of this investigational drug in patients with hypertension.

What phase is ISIS 757456 in?

ISIS 757456 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. Two Phase 2 trials have been completed, but the drug remains under investigation for hypertension.

What clinical trials is ISIS 757456 in?

ISIS 757456 has been studied in two completed Phase 2 clinical trials. NCT03714776 assessed the drug in participants with mild hypertension, while NCT04083222 evaluated it in patients with hypertension. Both trials were conducted in the United States and enrolled adult participants.

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

Yes, ISIS 757456 is also known as IONIS-AGT-LRx. The drug is an antisense inhibitor developed by Ionis Pharmaceuticals for the treatment of hypertension. Clinical trial records refer to the drug by both names, with IONIS-AGT-LRx being the more recent designation.