Adults 18 to 75, any sex, with Dyslipidaemia. 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.
Change in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12.Primary· Baseline to week 12
Change from baseline in low-density lipoprotein cholesterol (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.
Group
Value
95% CI
Placebo
0.978
0.834 – 1.147
AZD8233 High Dose
0.206
0.174 – 0.242
AZD8233 Medium Dose
0.270
0.230 – 0.317
AZD8233 Low Dose
0.606
0.517 – 0.710
Relative Change From Baseline in PCSK9 Concentration in Plasma at Week 12.Secondary· Baseline to week 12
Relative change from baseline in PCSK9 concentration in plasma at week 12.
Group
Value
95% CI
Placebo
0.950
0.770 – 1.180
AZD8233 High Dose
0.060
0.050 – 0.080
AZD8233 Medium Dose
0.110
0.090 – 0.140
AZD8233 Low Dose
0.420
0.340 – 0.520
Percentage Change From Baseline in Concentration of TC, HDL-C, Non-HDL-C, VLDL-C, ApoA1, ApoB, Lp(a), Triglycerides, Remnants CholesterolSecondary· Baseline to week 12
Percentage change from baseline in concentration of TC, HDL-C, Non-HDL-C, VLDL-C, ApoA1, ApoB, Lp(a), Triglycerides, Remnants cholesterol at week 12
Triglycerides
Group
Value
95% CI
Placebo
2.69
-8.19 – 13.56
AZD8233 High Dose
-12.70
-23.88 – -1.52
AZD8233 Medium Dose
-12.95
-23.77 – -2.12
AZD8233 Low Dose
-7.70
-18.44 – 3.05
Total cholesterol
Group
Value
95% CI
Placebo
-1.11
-6.56 – 4.35
AZD8233 High Dose
-47.58
-53.37 – -41.78
AZD8233 Medium Dose
-43.90
-49.43 – -38.37
AZD8233 Low Dose
-21.13
-26.56 – -15.70
HDL-C
Group
Value
95% CI
Placebo
1.34
-3.28 – 5.97
AZD8233 High Dose
5.57
0.90 – 10.25
AZD8233 Medium Dose
6.50
1.96 – 11.04
AZD8233 Low Dose
3.37
-1.12 – 7.86
Non-HDL-C
Group
Value
95% CI
Placebo
-0.65
-7.81 – 6.51
AZD8233 High Dose
-67.92
-75.38 – -60.45
AZD8233 Medium Dose
-61.25
-68.38 – -54.11
AZD8233 Low Dose
-29.57
-36.58 – -22.56
VLDL-C
Group
Value
95% CI
Placebo
3.22
-7.90 – 14.35
AZD8233 High Dose
-11.13
-22.59 – 0.33
AZD8233 Medium Dose
-12.09
-23.04 – -1.15
AZD8233 Low Dose
-7.54
-18.36 – 3.27
ApoB
Group
Value
95% CI
Placebo
-1.65
-7.83 – 4.53
AZD8233 High Dose
-67.07
-73.46 – -60.68
AZD8233 Medium Dose
-60.13
-66.33 – -53.93
AZD8233 Low Dose
-29.50
-35.64 – -23.35
Lp(a)
Group
Value
95% CI
Placebo
31.22
-2.88 – 65.33
AZD8233 High Dose
-37.74
-72.02 – -3.46
AZD8233 Medium Dose
-36.64
-70.69 – -2.59
AZD8233 Low Dose
-6.02
-40.62 – 28.58
Remnants cholesterol
Group
Value
95% CI
Placebo
6.38
-20.28 – 33.05
AZD8233 High Dose
-26.84
-54.23 – 0.54
AZD8233 Medium Dose
-16.54
-42.97 – 9.88
AZD8233 Low Dose
-13.50
-39.57 – 12.56
Plasma Concentration of AZD8233Secondary· Measurement at week 1, week 4, week 6, week 8, week 10, week 12, week 16, week 20, week 24 after first dose administration.
Plasma concentration of AZD8233 after first dose administration
Week 1
Group
Value
95% CI
AZD8233 High Dose
1.201
± 0.49
AZD8233 Medium Dose
0.681
± 0.24
AZD8233 Low Dose
0.346
± 0.59
Week 4
Group
Value
95% CI
AZD8233 High Dose
1.366
± 0.71
AZD8233 Medium Dose
0.699
± 0.33
AZD8233 Low Dose
0.238
± 0.21
Week 6
Group
Value
95% CI
AZD8233 High Dose
1.917
± 1.09
AZD8233 Medium Dose
0.870
± 0.34
AZD8233 Low Dose
0.288
± 0.21
Week 8
Group
Value
95% CI
AZD8233 High Dose
1.000
± 0.68
AZD8233 Medium Dose
0.628
± 0.57
AZD8233 Low Dose
0.152
± 0.10
Week 10
Group
Value
95% CI
AZD8233 High Dose
1.562
± 0.84
AZD8233 Medium Dose
0.751
± 0.29
AZD8233 Low Dose
0.241
± 0.15
Week 12
Group
Value
95% CI
AZD8233 High Dose
0.976
± 0.75
AZD8233 Medium Dose
0.476
± 0.23
AZD8233 Low Dose
0.134
± 0.07
Week 16
Group
Value
95% CI
AZD8233 High Dose
0.507
± 0.70
AZD8233 Medium Dose
0.297
± 0.53
AZD8233 Low Dose
0.087
± 0.09
Week 20
Group
Value
95% CI
AZD8233 High Dose
0.376
± 0.68
AZD8233 Medium Dose
0.153
± 0.26
AZD8233 Low Dose
0.053
± 0.004
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up PeriodSecondary· Measurement at week 0, week 1, week 4, week 8, week 12, week 16, week 20, week 24
ADA titre results for subjects with positive ADA during the treatment period and follow-up period.
Baseline
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 Medium Dose
200
200 – 200
AZD8233 Low Dose
100
100 – 100
Week 1
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 Medium Dose
200
200 – 200
AZD8233 Low Dose
100
50 – 800
Week 4
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 High Dose
75
50 – 100
AZD8233 Medium Dose
200
100 – 400
AZD8233 Low Dose
150
100 – 1600
Week 8
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 High Dose
75
50 – 100
AZD8233 Medium Dose
200
100 – 400
AZD8233 Low Dose
400
200 – 3200
Week 12
Group
Value
95% CI
Placebo
50
50 – 50
AZD8233 High Dose
200
200 – 200
AZD8233 Medium Dose
200
100 – 400
AZD8233 Low Dose
200
200 – 1600
Week 16
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 High Dose
300
200 – 400
AZD8233 Medium Dose
200
50 – 400
AZD8233 Low Dose
400
100 – 1600
Week 20
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 High Dose
500
200 – 800
AZD8233 Medium Dose
200
100 – 400
AZD8233 Low Dose
400
200 – 1600
Week 24
Group
Value
95% CI
Placebo
100
100 – 100
AZD8233 High Dose
200
50 – 800
AZD8233 Medium Dose
300
100 – 400
AZD8233 Low Dose
400
200 – 800
Percentage Change From Baseline in Levels of LDL-C in PlasmaSecondary· Baseline to week 12
Percentage change from baseline in levels of LDL-C in plasma from baseline to week 12.
Group
Value
95% CI
Placebo
-1.53
-9.14 – 6.09
AZD8233 High Dose
-76.50
-84.37 – -68.63
AZD8233 Medium Dose
-69.26
-76.89 – -61.63
AZD8233 Low Dose
-32.22
-39.79 – -24.66
Number of Subjects With an ECG Determined to be Abnormal and Clinically SignificantSecondary· Baseline to Week 24
Number of subjects with an ECG determined to be abnormal and clinically significant at baseline and end of treatment.
Baseline
Group
Value
95% CI
Placebo
0
AZD8233 High Dose
0
AZD8233 Medium Dose
0
AZD8233 Low Dose
0
End of treatment
Group
Value
95% CI
Placebo
0
AZD8233 High Dose
0
AZD8233 Medium Dose
0
AZD8233 Low Dose
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from time of first IP dose throughout the treatment period of 12 weeks and including the follow-up period of 12 weeks - a total of 24 weeks. Serious AEs were recorded from the time of signature of informed consent..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate the dose-dependent reduction in LDL-C after SC administration of multiple doses of AZD8233 as well as the associated adverse effects profile. The data generated will be used to guide choice of doses, dosing regimens, and sample sizes, as well as safety and PD monitoring in the further clinical development program.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05065463 — To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), E
· Phase 1
· terminated
NCT04964557 — A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
· Phase 2
· completed
NCT03593785 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects Wi
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 18 November 2022
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/NCT04641299.