AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate safety, efficacy and tolerability of AZD8233.
This is a randomized parallel, double-blind, placebo-controlled Phase 2b study in approximately 376 participants with hyperlipidaemia. The primary objective of the study is to assess the safety and tolerability of AZD8233 as compared with placebo, and the effect of AZD8233 versus placebo on relative change in LDL-C. The study will be conducted at up to 100 sites in up to 8 countries. The screening period starts up to 28 days before the randomization visit and ends on Day -1. Eligible participants will attend 1 enrollment visit and 15 visits during the treatment period and 2 additional visits during the safety follow up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
411
Percentage Change From Baseline on Serum LDL-C
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Time frame: From baseline to Day 197
Number of Subjects With Adverse Events (AEs)
Please refer to the adverse event module for specifics.
Time frame: On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
Vital Signs - Temperature
Mean and standard deviation of Temperature at each scheduled visit by treatment.
Time frame: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Vital Sign - Weight
Mean and standard deviation of Weight at each scheduled visit by treatment.
Time frame: Baseline and Day 281.
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment
Time frame: Baseline, Days 85, 169, 225, and 281.
Vital Sign - Systolic Blood Pressure
Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.
Time frame: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Vital Sign - Diastolic Blood Pressure
Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.
Time frame: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Huntsville, Alabama, United States
Research Site
Canoga Park, California, United States
Research Site
Lincoln, California, United States
Research Site
Inverness, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Meridian, Idaho, United States
Research Site
Indianapolis, Indiana, United States
Research Site
New Windsor, New York, United States
Research Site
Greensboro, North Carolina, United States
...and 56 more locations
Vital Sign - Pulse Rate
Mean and standard deviation of Pulse rate at each scheduled visit by treatment.
Time frame: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Treatment Emergent Platelet Count Abnormalities
Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.
Time frame: Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.
Percentage Change From Baseline on Serum PCSK9
Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.
Time frame: From baseline to Day 197
Plasma Concentration of AZD8233
AZD8233 full length ASO concentrations in plasma were summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.
Time frame: Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Number of ADA positive subjects at each time point during the treatment period and follow-up period.
Time frame: Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281