NCT04964557

A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia

A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate safety, efficacy and tolerability of AZD8233.

Detailed description

This is a randomized parallel, double-blind, placebo-controlled Phase 2b study in approximately 376 participants with hyperlipidaemia. The primary objective of the study is to assess the safety and tolerability of AZD8233 as compared with placebo, and the effect of AZD8233 versus placebo on relative change in LDL-C. The study will be conducted at up to 100 sites in up to 8 countries. The screening period starts up to 28 days before the randomization visit and ends on Day -1. Eligible participants will attend 1 enrollment visit and 15 visits during the treatment period and 2 additional visits during the safety follow up period.

Conditions

• Hyperlipidaemia

Interventions

Type	Name	Description
DRUG	AZD8233	PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
DRUG	Placebo	Placebo solution

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2021-07-16
• Last updated: 2023-12-15
• Results posted: 2023-12-15

Locations

66 sites across 8 countries: United States, Czechia, Denmark, Hungary, Netherlands, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study