NCT04823611

A Study of AZD8233 in Participants With Dyslipidemia.

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part A: This is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Approximately 11 Japanese participants will be randomized in an 8:3 ratio into 1 of the 2 single-blinded treatment arms; AZD8233 high dose or placebo. Participants will be dosed SC on Days 1, 8, 29, and 57. Part B:This is designed as a randomized, double-blind, placebo-controlled, dose-ranging, phase 2 study. Approximately 60 Japanese participants will be randomized in a 1:1:1 ratio into 1 of the 4 double-blinded treatment arms; AZD8233 low dose, AZD8233 medium dose, or placebo. Participants will be dosed SC on Days 1, 29, and 57. Part C:This is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled, multiple dose, phase 1 study. Approximately 11 Japanese participants will be randomized in an 8:3 ratio into 1 of the 2 single-blinded treatment arms; AZD8233 medium dose or placebo. Participants will be dosed SC on Days 1, 29, and 57.

Conditions

• Dyslipidemia

Interventions

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

Timeline

• Start date: 2021-01-20
• Primary completion: 2022-09-10
• Completion: 2022-09-10
• First posted: 2021-04-01
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

7 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study