drugset
drugset / Trial / NCT05065463

To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD) and Healthy Participants.

NCT05065463 ↗

Phase 1 Terminated 3 enrolled AstraZeneca Parexel · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The study is intended to assess the pharmacokinetics (PK), proprotein convertase subtilisin/kexin type 9 (PCSK9) reduction, safety and tolerability of AZD8233 in male and female participants with severe renal impairment and participants with ESRD compared to matched healthy control participants.

Timeline

Start
2022-08-10
Primary completion
2022-11-23
Completion
2022-11-23

Outcome

Outcome not reported

Stopped: “A decision has been taken to discontinue the development of AZD8233 (PCSK9-ASO for sc administration) due to low likelihood of demonstrating a benefit significantly above the current standard of care for patients with high-risk hypercholesterolemia.”

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD8233 Antisense oligonucleotide — Subcutaneous

Indications

end stage renal failure