Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD8233 subcutaneous injection
AZD8233 · 5 trials · 4 indications
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Please refer to the adverse event module for specifics.
Mean and standard deviation of Temperature at each scheduled visit by treatment.
Mean and standard deviation of Weight at each scheduled visit by treatment.
Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment
Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.
Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.
Mean and standard deviation of Pulse rate at each scheduled visit by treatment.
Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.
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.
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
To assess AEs as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses. Serious AEs will be recorded from the time of informed consent.
To assess SBP as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses. BP will be collected after the subject has rested in the supine position for at least 5 minutes.
To assess supine position pulse as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses. Pulse rate will be collected after the subject has rested in the supine position for at least 5 minutes.
To assess the oral body temperature as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the clinically significant abnormalities in the cardiovascular system functioning using a 12-lead ECG as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses. ECG evaluations will be recorded after approximately 10 min resting in supine position. dECGs will be done only on Days 1 and 57 (pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24, 36 and 48 hours post-dose), and Days 8 and 29 (pre-dose).
To assess cardiac telemetry as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess physical examination as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses. Complete (general appearance, respiratory, cardiovascular, abdomen, skin, head and neck \[including ears, eyes, nose and throat\], lymph nodes, thyroid, musculoskeletal \[including spine and extremities\] and neurological systems).
To assess injection site reactions in terms of size (mm), color (pale/light red/dark red), and itching (yes or no)as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess red blood cells (RBC) and white blood cells (WBC) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess Hb as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess HCT as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess MCV as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess MCH as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess MCHC as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess differential WBC count absolute count of neutrophils, lymphocytes, monocytes, eosinophils and basophils as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess platelet count and platelet function in platelet rich plasma (PRP) using Light Transmission Aggregometry (LTA) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess Reticulocytes absolute count as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess serum level of sodium, potassium, calcium as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess serum level of BUN as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess serum level of creatinine as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess serum fasting glucose level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of serum creatine kinase as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of serum bilirubin (direct) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of HbA1c as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Gamma glutamyl transpeptidase (GGT) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of serum bilirubin (total) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of serum glutamate dehydrogenase (GLDH) and lactate dehydrogenase (LDH) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of bicarbonate as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess the level of uric acid as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess activated partial thrombin time (aPTT), prothrombin time (PT), and International normalized ratio (INR) as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine clusterin level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine cystatin-C level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine NAG level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine albumin level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine creatinine level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine KIM-1 level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine NAG level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine osteopontin level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess renal biomarker by evaluation of urine protein (total) level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess hs-CRP level as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess chemotactic factor (C3a, Bb, and C5a) levels as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess urine sample for proteins, blood, creatinine, microscopy evaluation as a variable of safety and tolerability of AZD8233 following SC administration of multiple ascending doses.
To assess AEs as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses. Serious AEs will be recorded from the time of informed consent.
To assess supine position systolic and diastolic BP as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses. Both SBP and DBP will be collected after the subject has rested in the supine position for at least 10 minutes.
To assess any clinically significant abnormalities in the cardiovascular system functioning using a 12-lead ECG as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses. ECG evaluations will be recorded after approximately 10 min resting in supine position.
To assess red blood cells ( RBC) and white blood cells (WBC) count as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess Hb as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess HCT (volume percentage of RBC in blod) as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess MCV as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess MCH as a variable of safety and tolerability following SC administration of single ascending doses.
To assess MCHC as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess differential WBC count absolute count of neutrophils, lymphocytes, monocytes, eosinophils and basophils as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess platelets count as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess reticulocytes absolute count as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess serum level of urea as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess serum level of high density lipoprotein, low density lipoprotein, triglycerides and total cholesterol as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess urine glucose level as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess urine protein level as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess presence of blood in urine as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess urine creatinine level as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
If protein or blood present in urine, levels of RBC, WBC, Casts (Cellular, Granular, Hyaline) will be assessed as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess renal biomarker by evaluation of serum creatinine level, as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess renal biomarker by evaluation of urine protein level, as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess renal biomarker by evaluation of eGFR, as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess renal biomarker by evaluation of urine KIM-1 level, as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess renal biomarker by evaluation of Alpha-GST level in urine, as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess hs-CRP level as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
To assess heart rhythm and QRS pattern (heart conduction) as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses. ECG evaluations will be recorded after approximately 10 min resting in supine position.
To assess serum level of Uric acid as a variable of safety and tolerability of AZD8233 following SC administration of single ascending doses.
| Arm | Type | Description |
|---|---|---|
| AZD8233 | EXPERIMENTAL | AZD8233 for subcutaneous use |
| Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection |
| AZD8233 high dose | EXPERIMENTAL | AZD8233 high dose for subcutaneous injection. |
| AZD8233 medium dose | EXPERIMENTAL | AZD8233 medium dose for subcutaneous injection. |
| AZD8233 low dose | EXPERIMENTAL | AZD8233 low does for subcutaneous injection. |
| Part A:Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part A:AZD8233 | EXPERIMENTAL | AZD8233 for subcutaneous injection. |
| Part B:Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part B:AZD8233 medium dose | EXPERIMENTAL | AZD8233 medium dose for subcutaneous injection. |
| Part B:AZD8233 low dose | EXPERIMENTAL | AZD8233 low dose for subcutaneous injection. |
| Part C: Placebo | PLACEBO_COMPARATOR | Placebo solution for subcutaneous injection. |
| Part C: AZD8233 medium dose | EXPERIMENTAL | AZD8233 medium dose for subcutaneous injection. |
| Cohort 1 | EXPERIMENTAL | On Days 1, 8, 29, and 57, randomized subjects will receive SC dose of AZD8233 dose 1 injection (8 subjects) or matching placebo (3 subjects). |
| Cohort 2 | EXPERIMENTAL | On Days 1, 8, 29, and 57, randomized subjects will receive SC dose of AZD8233 dose 2 injection (8 subjects) or matching placebo (3 subjects). |
| Cohort 3 | EXPERIMENTAL | On Days 1, 8, 29, and 57, randomized subjects will receive SC dose of AZD8233 dose 3 injection (8 subjects) or matching placebo (3 subjects). |
| Cohort 4 | EXPERIMENTAL | On Day 1, randomized subjects will receive single SC dose of AZD8233 dose 4 injection (6 subjects) or matching placebo (2 subjects). |
| Cohort 5 | EXPERIMENTAL | On Day 1, randomized subjects will receive single SC dose of AZD8233 dose 5 injection (6 subjects) or matching placebo (2 subjects). |
| Name | Type | Description |
|---|---|---|
| AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| Placebo | DRUG | Placebo solution |
| Part A:Placebo | DRUG | Placebo solution |
| Part A:AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| Part B:Placebo | DRUG | Placebo solution |
| Part B:AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| Part C: Placebo | DRUG | Placebo solution |
| Part C: AZD8233 | DRUG | PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. |
| AZD8233 subcutaneous injection | DRUG | Randomized subjects will receive SC dose of AZD8233 (dose 1, dose 2, and dose 3) injection. |
Inclusion Criteria: * Participant must be 18 to 75 years of age, inclusive, at the time of signing the informed consent * Participants who have a fasting LDL-C ≥ 70 mg/dL (1.8 mmol/L) but \< 190 mg/dL (4.9 mmol/L) at screening * Participants who have fasting triglycerides \< 400 mg/dL (\< 4.52 mmol...
AZD8233 is an investigational small molecule developed by AstraZeneca PLC for cardiovascular conditions marked by abnormal lipid levels. It has been studied in dyslipidaemia, dyslipidemia, hypercholesterolemia, and hyperlipidaemia. The program reached Phase 2 clinical development, and all reported trials of the drug have been completed.
AZD8233 is being studied for the treatment of lipid disorders, specifically dyslipidaemia, dyslipidemia, hypercholesterolemia, and hyperlipidaemia. These conditions involve elevated or abnormal cholesterol and lipid levels in the blood. The drug is investigational and has not been approved for any use.
AZD8233 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical program evaluating the drug in patients with lipid disorders. The compound is an AstraZeneca pipeline asset in the cardiovascular therapeutic area.
AZD8233 is in Phase 2 development. Two Phase 2 trials and two Phase 1 trials have been conducted, and all four studies are listed as completed. The drug remains investigational and is not approved for marketing in any indication.
AZD8233 has been evaluated in completed trials including NCT04964557, a Phase 2 study in hyperlipidaemia with 411 participants across the United States and several European countries, and NCT04641299, a Phase 2 dyslipidaemia study with 119 participants. Earlier Phase 1 studies include NCT04823611 in Japan and NCT04155645 in the United States.
Yes. AZD8233 subcutaneous injection refers to the same investigational compound, and trial records also label study parts as Part A:AZD8233, Part B:AZD8233, and Part C: AZD8233. These are alternate names for the AstraZeneca drug studied in dyslipidaemia, dyslipidemia, hypercholesterolemia, and hyperlipidaemia.