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NCT04823611: HAYATE

A Study of AZD8233 in Participants With Dyslipidemia.

Completed Phase 1, PHASE2 Results posted Last updated 24 December 2024
What this trial tests

Phase 1, PHASE2 trial testing Part A:Placebo in Dyslipidemia in 87 participants. Completed in 10 September 2022.

Timeline
20 January 2021
Primary endpoint
10 September 2022
10 September 2022

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment87
Start date20 January 2021
Primary completion10 September 2022
Estimated completion10 September 2022
Sites7 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 20 to 75, any sex, with Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part B: Change in LDL-C in Serum at Week 12 Primary · 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

GroupValue95% CI
Part B:AZD8233 50mg0.1980.167 – 0.235
Part B:AZD8233 15mg0.4580.388 – 0.541
Part B:Placebo0.9530.806 – 1.128
Part B: Percentage Change From Baseline in LDL-C in Serum at Week 12 Secondary · Measurement at baseline and week 12

Percentage change from baseline to week 12 in Low-density Lipoprotein Cholesterol (LDL-C) in serum

GroupValue95% CI
Part B:AZD8233 50mg-77.13-83.67 – -70.59
Part B:AZD8233 15mg-52.48-58.85 – -46.11
Part B:Placebo-3.24-9.68 – 3.19
Part B: Change in PCSK9 in Plasma at Week 12 Secondary · 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

GroupValue95% CI
Part B:AZD8233 50mg0.0660.055 – 0.079
Part B:AZD8233 15mg0.2960.248 – 0.352
Part B:Placebo0.8740.731 – 1.045
Part B: Percentage Change From Baseline in PCSK9 in Plasma at Week 12 Secondary · Measurement at baseline and week 12

Percentage change from baseline to week 12 in proprotein convertase subtilisin/kexin type-9 (PCSK9) in plasma

GroupValue95% CI
Part B:AZD8233 50mg-92.91-99.00 – -86.82
Part B:AZD8233 15mg-65.07-71.03 – -59.12
Part B:Placebo-11.92-18.01 – -5.82
Part A & Part C: AUC (0-24) of AZD8233 Secondary · Day 1 and Day 57

Area Under the plasma concentration time curve from time 0 to time 24 hours

Day 1
GroupValue95% CI
Part A:AZD8233 90mg5736± 53.55
Part C: AZD8233 60mg3906± 26.56
Day 57
GroupValue95% CI
Part A:AZD8233 90mg5377± 50.57
Part C: AZD8233 60mg3493± 32.47
Part A & Part C: Cmax of AZD8233 Secondary · Day 1 and Day 57

Maximum plasma concentration

Day 1
GroupValue95% CI
Part A:AZD8233 90mg1525± 62.11
Part C: AZD8233 60mg830.8± 23.90
Day 57
GroupValue95% CI
Part A:AZD8233 90mg1271± 70.63
Part C: AZD8233 60mg781.2± 50.34
Part A & Part C: t1/2 of AZD8233 Secondary · Day 1 and Day 57

Terminal half-life

Day 1
GroupValue95% CI
Part A:AZD8233 90mg3.459± 45.69
Part C: AZD8233 60mg2.751± 35.94
Day 57
GroupValue95% CI
Part A:AZD8233 90mg2.848± 44.73
Part C: AZD8233 60mg2.527± 28.36
Part A & Part C: CL/F (L/h) of AZD8233 Secondary · Day 1 and Day 57

Apparent plasma clearance

Day 1
GroupValue95% CI
Part A:AZD8233 90mg15.58± 52.84
Part C: AZD8233 60mg15.31± 26.36
Day 57
GroupValue95% CI
Part A:AZD8233 90mg16.62± 50.44
Part C: AZD8233 60mg17.14± 32.25
Part A & Part C: Vz/F (L) Secondary · Day 1 and Day 57

Apparent Volume of distribution during the terminal phase

Day 1
GroupValue95% CI
Part A:AZD8233 90mg77.74± 106.7
Part C: AZD8233 60mg60.77± 56.66
Day 57
GroupValue95% CI
Part A:AZD8233 90mg68.30± 58.04
Part C: AZD8233 60mg62.49± 56.80

Adverse events — posted to ClinicalTrials.gov

Time frame: From date of first dose, throughout treatment period and including follow-up period, 24 weeks for Parts A, B and C.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A:AZD8233 90mg
Serious: 0/8 (0%)
Deaths: 0/8
Part A:Placebo
Serious: 0/3 (0%)
Deaths: 0/3
Part B:AZD8233 50mg
Serious: 0/22 (0%)
Deaths: 0/22
Part B:AZD8233 15mg
Serious: 0/22 (0%)
Deaths: 0/22
Part B:Placebo
Serious: 0/21 (0%)
Deaths: 0/21
Part C: AZD8233 60mg
Serious: 0/8 (0%)
Deaths: 0/8
Part C: Placebo
Serious: 0/3 (0%)
Deaths: 0/3
Other adverse events (27 terms — click to expand)

ReactionSystemPart A:AZD8233 90mgPart A:PlaceboPart B:AZD8233 50mgPart B:AZD8233 15mgPart B:PlaceboPart C: AZD8233 60mgPart C: Placebo
Hepatic function abnormalHepatobiliary disorders
COVID-19Infections and infestations
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders
CystitisInfections and infestations
MyringitisInfections and infestations
Oral herpesInfections and infestations
NasopharyngitisInfections and infestations
Carpal tunnel syndromeNervous system disorders
Ventricular extrasystolesCardiac disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Rhinitis allergicRespiratory, thoracic and mediastinal disorders
Dental cariesGastrointestinal disorders
ToothacheGastrointestinal disorders
BlisterSkin and subcutaneous tissue disorders
Hand dermatitisSkin and subcutaneous tissue disorders
UrticariaSkin and subcutaneous tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Injection site reactionGeneral disorders
Oedema peripheralGeneral disorders
BiteInjury, poisoning and procedural complications
ContusionInjury, poisoning and procedural complications
FallInjury, poisoning and procedural complications
Rib fractureInjury, poisoning and procedural complications
Pain in extremityMusculoskeletal and connective tissue disorders
PyrexiaGeneral disorders
Blood creatine phosphokinase increasedInvestigations

Data from ClinicalTrials.gov NCT04823611 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. RNA Therapeutics: the Next Generation of Drugs for Cardiovascular Diseases.
    Bejar N, Tat TT, Kiss DL. · · 2022 · cited 32× · PMID 35364795 · DOI 10.1007/s11883-022-01007-9
  2. RNA-based therapies in liver metabolic diseases.
    Fontanellas A, Berraondo P, Urigo F, Jericó D, et al · · 2025 · cited 9× · PMID 39988358 · DOI 10.1136/gutjnl-2023-331742
  3. Population pharmacokinetics of a novel PCSK9 antisense oligonucleotide.
    Clewe O, Rekić D, Quartino AL, Carlsson B, et al · · 2024 · cited 3× · PMID 38504437 · DOI 10.1111/bcp.16046

Verify or expand the search:

Other recruiting trials for Dyslipidemia

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04823611.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing