RecruitingHypercholesterolaemia

A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

Eligible age

18–75 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: Novartis Pharmaceuticals

You may qualify if…

✓ 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 local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1.
✓ The following parameters must be confirmed at Screening Visit 2:
✓ Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation.
✓ Fasting triglyceride \<400 mg/dL.

You may not qualify if…

✕ Symptomatic orthostatic hypotension.
✕ Treatment with certain medications and/or unable to comply with prohibited medications requirements.
✕ Other protocol inclusion/exclusion criteria may apply