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Review, Journal: Will zilebesiran, an RNA interference therapy, be effective, safe, and improve the treatment of hypertension? (Pubmed Central) - Dec 4, 2024 It was also difficult to reliably interpret the results of KARDIA-1 as blood pressure went up significantly in the placebo group. KARDIA-1 did not answer previous concerns about zilebesiran; (i) what happens during volume depletion, sepsis, and pregnancy when angiotensinogen is inhibited long-term or (ii) will it be effective in a high sodium diet.
- |||||||||| zilebesiran (ALN-AGT) / Alnylam, Roche, IONIS-AGT-LRx / Ionis
Injectable angiotensinogen inhibition therapy for hypertension: a systematic review and meta-analysis (Station 7 - Research Gateway) - May 14, 2024 - Abstract #ESC2024ESC_4571; Conclusions In this meta-analysis of RCTs, injectable AGT inhibitors were associated with a significant decrease in mean AGT, SBP, and DBP as compared with placebo. There were no significant differences between groups in serious adverse events, although injection site reaction was more common in patients treated with injectable AGT inhibitors.
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Clinical, P1 data, P2 data, Journal: Antisense Inhibition of Angiotensinogen With IONIS-AGT-L: Results of Phase 1 and Phase 2 Studies. (Pubmed Central) - Jul 6, 2021 P1, P2 In conclusion, IONIS-AGT-L significantly reduces AGT with a favorable safety, tolerability, and on-target profile. (A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx; NCT04083222; A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Subjects With Controlled Blood Pressure; NCT03714776; Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers; NCT03101878).
- |||||||||| IONIS-AGT-LRx / Ionis
Enrollment open: ASTRAAS-HF: A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction (clinicaltrials.gov) - Apr 13, 2021 P2, N=72, Recruiting, (A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx; NCT04083222; A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx, an Antisense Inhibitor Administered Subcutaneously to Hypertensive Subjects With Controlled Blood Pressure; NCT03714776; Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers; NCT03101878). Not yet recruiting --> Recruiting
- |||||||||| IONIS-AGT-LRx / Ionis
Trial completion, Trial completion date: A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx (clinicaltrials.gov) - Sep 15, 2020 P2, N=26, Completed, A dose-ranging, Ph2B study is underway in subjects with resistant HTN on ≥ 3 meds, as well a Ph2 study in patients with heart failure with reduced ejection fraction. Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> Jul 2020
- |||||||||| IONIS-AGT-LRx / Ionis
Enrollment closed, Trial primary completion date: 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 (clinicaltrials.gov) - Feb 27, 2019 P2, N=30, Active, not recruiting, Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2019 --> Jan 2020
- |||||||||| IONIS-AGT-LRx / Ionis
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers (clinicaltrials.gov) - May 3, 2018 P1, N=62, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2019 --> Aug 2018 | Trial primary completion date: Nov 2018 --> May 2018
- |||||||||| IONIS-AGT-LRx / Ionis
Trial completion date, Trial primary completion date: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers (clinicaltrials.gov) - Mar 3, 2018 P1/2, N=82, Recruiting, Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2019 --> Aug 2018 | Trial primary completion date: Nov 2018 --> May 2018 Trial completion date: Dec 2018 --> Jan 2019 | Trial primary completion date: Oct 2018 --> Nov 2018
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