CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Part A:Placebo +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04823611
NCT04823611Phase 2Completed
CompareCT.gov

A Phase 1 and 2 Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of AZD8233 Following a Multiple Subcutaneous Dose Administration in Japanese Participants With Dyslipidemia

AstraZeneca·interventional·Posted Apr 1, 2021·Updated Dec 24, 2024

In Brief

A Phase 2 clinical trial evaluating Part A:Placebo, Part A:AZD8233, and 4 other interventions for Dyslipidemia. Completed, enrolled 87 participants across 7 sites.

Detailed Summary

A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A , Part B and Part C. Part A is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Part B is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Part C is designed as a randomized , single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 1, 2021
Enrollment StartJan 20, 2021
Primary CompletionSep 10, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.3 years ago

Interventions

Part A:Placebodrug

Placebo solution

Part A:AZD8233drug

PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.

Part B:Placebodrug

Placebo solution

Part B:AZD8233drug

PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.

Part C: Placebodrug

Placebo solution

Part C: AZD8233drug

PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.