This is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
The study will last up to 12 months and has three periods: * Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit. * Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit. * Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
QCZ484 once on Day 1
Inclisiran once on Day 1
QCZ484 placebo once on Day 1
Percent change from baseline of PCSK9 levels
Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3
Time frame: Baseline and Month 3
Percent change from baseline of AGT levels
Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3
Time frame: Baseline and Month 3
Change from baseline of systolic blood pressure
Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.
Time frame: Baseline, Month 3 and Month 6
Change from baseline of LDL-C levels
Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.
Time frame: 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
Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.
Time frame: Up to month 12
Novartis Pharmaceuticals
CONTACT
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Inclisiran placebo once on Day 1
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