Drugs / AZD8233
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05065463 | Aug → Nov 2022 | end stage renal failure | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT04155645 | Nov 2019 → Jun 2021 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03593785 | Aug 2018 → Dec 2020 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04823611 | Jan 2021 → Sep 2022 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 22 trials · 2 met primary | ||||||
| Phase 2 | NCT04964557 | Jul 2021 → Jul 2022 | hyperlipidemia | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT04641299 | Oct 2020 → Jul 2021 | hyperlipidemia | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-10-31 | AstraZeneca | Results AstraZeneca advances scientific leadership in cardiovascular and renal diseases with over 60 abstracts collectively at ASN Kidney Week 2022 and AHA Scientific Sessions 2022 astrazeneca.com ↗
The PCSK9-targeted antisense oligonucleotide AZD8233 reduces LDL-C, ApoB, and Lp(a) in patients with dyslipidemia on statin treatment - Data from the phase 2b ETESIAN study |
| 2022-09-23 | Ionis Pharmaceuticals | Results Ionis provides update on development program evaluating PCSK9 antisense medicine for the treatment of hypercholesterolemia ionis.com ↗
However, these results did not achieve pre-specified efficacy criteria and AstraZeneca has decided not to advance ION449 (AZD8233) into Phase 3 development for hypercholesterolemia. |
| 2022-04-04 | AstraZeneca | Results AZD8233 reduced low-density lipoprotein cholesterol levels by 73% in patients with high-risk hypercholesterolemia in ETESIAN Phase IIb trial astrazeneca.com ↗
Positive results from the ETESIAN Phase IIb trial showed AZD8233 (an investigational antisense oligonucleotide [ASO], also known as ION449) met the primary endpoint at 50 mg with 73% (95% confidence interval [CI]: -77%, -68%) reduction in low-density lipoprotein cholesterol (LDL-C) levels, from baseline. |
| 2022-04-04 | Ionis Pharmaceuticals | Results Ionis announces positive data for ETESIAN Phase 2b study of antisense medicine targeting PCSK9 at 2022 American College of Cardiology Scientific Session ionis.com ↗ |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AZD8233 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04641299 ↗ |
| Action | Inhibit | “to reduce hepatocyte PCSK9 protein production and plasma levels” PMID 38504437 ↗ Mar 2024 |
| Modality | Antisense oligonucleotide | “AZD8233, an antisense oligonucleotide (ASO)” PMID 38504437 ↗ Mar 2024 |
| Route | Subcutaneous | “following subcutaneous (SC) administration of single ascending dose (SAD) of AZD8233” NCT03593785 ↗ |
| Target | PCSK9 | “targets the PCSK9 transcript” PMID 38504437 ↗ Mar 2024 |