Novartis Pharmaceuticals
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…
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 sitting measurements based on office blood pressure monitoring. * Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and…
QCZ484 once on Day 1
Inclisiran once on Day 1
QCZ484 placebo once on Day 1
Inclisiran placebo once on Day 1