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)
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- STATUS
- Recruiting
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- End date
- Jan 1, 2023
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- participants needed
- 72
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- sponsor
- Ionis Pharmaceuticals, Inc.
Summary
The purpose of this study is to evaluate the effect of IONIS-AGT-LRX weekly subcutaneous (SC) injection on plasma angiotensinogen (AGT) concentration from Baseline to Study Day 85 (Week 13) and to evaluate the effect of IONIS-AGT-LRx weekly SC injection on plasma AGT concentration and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) levels at each scheduled visit in chronic heart failure participants with reduced ejection fraction (HFrEF).
Description
This study will be a Phase 2, double-blind, randomized, placebo-controlled study in up to 72 participants. Participants will be randomized in a 2:1 ratio to either IONIS-AGT-LRX or matching placebo and receive a once-weekly SC treatment. The length of participation in the study will be approximately 35 weeks, which includes an up to 10-week screening period, a 12-week treatment period, and a 13-week post-treatment period.
Details
| Condition | Chronic Heart Failure With Reduced Ejection Fraction |
|---|---|
| Treatment | Placebo, IONIS-AGT-LRx |
| Clinical Study Identifier | NCT04836182 |
| Sponsor | Ionis Pharmaceuticals, Inc. |
| Last Modified on | 1 July 2022 |
Eligibility
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