A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction

(ASTRAAS-HF Trial)

Recruiting at 28 trial locations

Overseen By Ionis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ionis Pharmaceuticals, Inc.

Must be taking: ACEi, ARBs, Beta-blockers, MRAs

Disqualifiers: Severe pulmonary disease, Uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

72 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to continue their current heart failure medications, including an ACE inhibitor, ARB, or sacubitril/valsartan, a beta-blocker, and a mineralocorticoid receptor antagonist, unless they are not tolerated. Your current medications should be stable for at least 4 weeks before joining the study.

What is the purpose of this trial?

This trial tests a weekly under-the-skin shot called IONIS-AGT-LRX for people with a type of heart failure where the heart doesn't pump well. The treatment aims to lower specific proteins in the blood that affect heart function and fluid balance. The study will last several months and include up to 72 participants.

Eligibility Criteria

Inclusion Criteria

Females must be non-pregnant and non-lactating and of non- childbearing potential.

An angiotensin-converting-enzyme inhibitor (ACEi), or angiotensin II receptor blockers (ARBs) or sacubitril/valsartan (mandatory)

A beta-blocker (unless contraindicated or not tolerated)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 10 weeks

Treatment

Participants receive IONIS-AGT-LRx or placebo via subcutaneous injection once-weekly

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Treatment Details

Interventions

• IONIS-AGT-LRx

Participant Groups

Group I: IONIS-AGT-LRx Experimental Treatment 1 Intervention

IONIS-AGT-LRX by subcutaneous injection once-weekly

Group II: Placebo Placebo Group 1 Intervention

Matching placebo by subcutaneous injection once-weekly

Who Is Running the Clinical Trial?

Ionis Pharmaceuticals, Inc.

Lead Sponsor

Trials

151

Recruited

27,800+

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD