Part A:Placebo
DrugPlacebo solution
NCT Number: NCT04823611
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.
Looking for future studies?
Notify Me20 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Research Site, Chiyoda-ku, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Part A
Part B
Part C
Key Exclusion Criteria:
Part A
Part B
Part C
Placebo solution
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo solution
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Placebo solution
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
Time frame: Baseline to week 12
Part B: Change from baseline in LDL-C at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
Time frame: Measurement at baseline and week 12
Percentage change from baseline to week 12 in Low-density Lipoprotein Cholesterol (LDL-C) in serum
Time frame: Baseline to week 12
Part B: Change from baseline in PCSK9 in plasma at week 12. Results are based on Mixed Model Repeated Measures (MMRM) analysis on the log-transformed change from baseline. Log-transformed change from baseline is calculated as the visit value in log minus the baseline value in log. The results from the model are then back transformed. Note: log(week 12 data) - log(baseline data) = log(week12/baseline), which is a ratio
Time frame: Measurement at baseline and week 12
Percentage change from baseline to week 12 in proprotein convertase subtilisin/kexin type-9 (PCSK9) in plasma
Time frame: Day 1 and Day 57
Area Under the plasma concentration time curve from time 0 to time 24 hours
Time frame: Day 1 and Day 57
Maximum plasma concentration
Time frame: Day 1 and Day 57
Terminal half-life
Time frame: Day 1 and Day 57
Apparent plasma clearance
Time frame: Day 1 and Day 57
Apparent Volume of distribution during the terminal phase
AstraZeneca
Industry
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
Acronym: HAYATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07655960
Dyslipidemia, Dyslipidemias
Seoul, South Korea
View Trial DetailsNCT07691268
Dyslipidemia, Dyslipidemias
Seoul, Gwanak-gu 08779, South Korea
View Trial DetailsNCT07627555
Cardiovascular Diseases, Dyslipidemia
Lahore, Pakistan
View Trial DetailsNCT00001154
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dyslipidemia
Bethesda, Maryland, United States
View Trial Details