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QCZ484

Phase 2

Hypercholesterolaemia | Small molecule | Metabolic |Novartis AG|Last Updated: May 27, 2026

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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07610278A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant HypercholesterolemiaPHASE2 NOT YET_RECRUITING 120Jun 3, 2026Jan 28, 2028May 27, 2026 -
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Study Endpoints
Primary Endpoints
Percent change from baseline of PCSK9 levels
Baseline and Month 3

Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3

Percent change from baseline of AGT levels
Baseline and Month 3

Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3

Secondary Endpoints
Change from baseline of systolic blood pressure
Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Baseline, Month 3 and Month 6
Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments
Up to month 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QCZ484 + InclisiranEXPERIMENTALQCZ484 + inclisiran, once on Day 1
QCZ484ACTIVE_COMPARATORQCZ484 + inclisiran placebo, once on Day 1
InclisiranACTIVE_COMPARATORInclisiran + QCZ484 placebo, once on Day 1
PlaceboPLACEBO_COMPARATORQCZ484 placebo + inclisiran placebo, once on Day 1
Interventions
NameTypeDescription
QCZ484DRUGQCZ484 once on Day 1
InclisiranDRUGInclisiran once on Day 1
QCZ484 placeboDRUGQCZ484 placebo once on Day 1
Inclisiran placeboDRUGInclisiran placebo once on Day 1
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or females aged 18 to 75 years. * Diagnosis of primary hypertension. * Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening. * Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sittin...

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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07610278NEW_TRIAL: changed
LOWMay 28, 2026NCT07610278NEW_TRIAL: changed