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MEDI6570

Phase 2

Coronary Heart Disease (CHD) | Monoclonal antibody | Cardiovascular |AstraZeneca PLC|Last Updated: Feb 21, 2025

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment423
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04610892Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial InfarctionPHASE2 COMPLETED 423 — — Nov 4, 2020Nov 8, 2023Feb 21, 202584 United States, Australia +9
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Study Endpoints
Primary Endpoints
Change From Baseline to Day 253 in Non-calcified Plaque Volume in the Most Diseased Coronary Segment (NCPVMD), as Measured by Computed Tomography Angiography (CTA) Imaging
From baseline to Day 253

To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.

Secondary Endpoints
Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)
From baseline to Day 253
Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
From baseline to Day 253
Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
From baseline to Day 253
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI6570 Low doseEXPERIMENTALMonthly Subcutaneous administration.
MEDI6570 Medium doseEXPERIMENTALMonthly Subcutaneous administration.
MEDI6570 High doseEXPERIMENTALMonthly Subcutaneous administration.
Placebo Low dosePLACEBO_COMPARATORMonthly Subcutaneous administration.
Placebo Medium dosePLACEBO_COMPARATORMonthly Subcutaneous administration
Placebo High dosePLACEBO_COMPARATORMonthly Subcutaneous administration
Interventions
NameTypeDescription
MEDI6570BIOLOGICALMEDI6570
PlaceboBIOLOGICALBuffer
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites84

Inclusion Criteria: 1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities. 2. Women must be ≥ 40 y...

Countries:United StatesAustraliaCanadaCzechiaHungaryItalyJapanNetherlandsPolandSpainUnited Kingdom
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