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AZD8233

Phase 2

Hyperlipidaemia | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Dec 15, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment411
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04964557A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With HyperlipidaemiaPHASE2 COMPLETED 411 — — Jul 7, 2021Jul 15, 2022Dec 15, 202366 United States, Czechia +6
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Study Endpoints
Primary Endpoints
Percentage Change From Baseline on Serum LDL-C
From baseline to Day 197

Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.

Number of Subjects With Adverse Events (AEs)
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.

Please refer to the adverse event module for specifics.

Vital Signs - Temperature
Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Temperature at each scheduled visit by treatment.

Vital Sign - Weight
Baseline and Day 281.

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
Baseline, Days 85, 169, 225, and 281.

Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment

Vital Sign - Systolic Blood Pressure
Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.

Vital Sign - Diastolic Blood Pressure
Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.

Vital Sign - Pulse Rate
Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Pulse rate at each scheduled visit by treatment.

Treatment Emergent Platelet Count Abnormalities
Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.

Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.

Secondary Endpoints
Percentage Change From Baseline on Serum PCSK9
From baseline to Day 197
Plasma Concentration of AZD8233
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
Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD8233EXPERIMENTALAZD8233 for subcutaneous use
PlaceboPLACEBO_COMPARATORPlacebo solution for subcutaneous injection
Interventions
NameTypeDescription
AZD8233DRUGPCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
PlaceboDRUGPlacebo solution
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites66

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...

Countries:United StatesCzechiaDenmarkHungaryNetherlandsPolandSlovakiaSpain
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