Phase 2
Completed N=87
A Study of AZD8233 in Participants With Dyslipidemia.
Source: ClinicalTrials.gov NCT04823611 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Part B: Change in LDL-C in Serum at Week 12 — 0.198; 0.458; 0.953 Ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: Change in LDL-C in Serum at Week 12 |
0.198; 0.458; 0.953 | — |
| SECONDARY Part B: Percentage Change From Baseline in LDL-C in Serum at Week 12 |
-77.13; -52.48; -3.24 | — |
| SECONDARY Part B: Change in PCSK9 in Plasma at Week 12 |
0.066; 0.296; 0.874 | — |
| SECONDARY Part B: Percentage Change From Baseline in PCSK9 in Plasma at Week 12 |
-92.91; -65.07; -11.92 | — |
| SECONDARY Part A & Part C: AUC (0-24) of AZD8233 |
5736; 3906; 5377; 3493 | — |
| SECONDARY Part A & Part C: Cmax of AZD8233 |
1525; 830.8; 1271; 781.2 | — |
| SECONDARY Part A & Part C: t1/2 of AZD8233 |
3.459; 2.751; 2.848; 2.527 | — |
| SECONDARY Part A & Part C: CL/F (L/h) of AZD8233 |
15.58; 15.31; 16.62; 17.14 | — |
| SECONDARY Part A & Part C: Vz/F (L) |
77.74; 60.77; 68.30; 62.49 | — |
Eligibility Criteria
Key Inclusion Criteria
Part A
- Participants must be 20 to 60 years of age inclusive, at the time of signing the informed consent
- Participants who have a fasting LDL-C ≥ 70 mg/dL but 100 beats per minute
- Uncontrolled hypertension defined as sitting SBP > 140 mmHg or DBP > 90 mmHg
Part B
- eGFR 10% at Visit 1
- Acute ischaemic cardiovascular event in the last 12 months prior to randomization
- Heart failure with New York Heart Association (NYHA) Class III-IV
- High-risk of bleeding diathesis as judged by the Investigator
- Uncontrolled hypertension defined as sitting SBP > 160 mmHg or DBP > 90 mmHg at Visit 1 or Visit 3
- Heart rate after 10 minutes sitting rest 100 bpm at Visit 1 or Visit 3
Part C
- eGFR 100 beats per minute
- Uncontrolled hypertension defined as sitting SBP > 140 mmHg or DBP > 90 mmHg
Data sourced from ClinicalTrials.gov (NCT04823611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.