A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07610278
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Hypercholesterolaemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- QCZ484 — DRUGQCZ484 once on Day 1
- Inclisiran — DRUGInclisiran once on Day 1
- QCZ484 placebo — DRUGQCZ484 placebo once on Day 1
- Inclisiran placebo — DRUGInclisiran placebo once on Day 1
Study Details
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.
Key Dates
- Start date
- Jun 3, 2026
- Status verified
- May 2026
- Primary completion
- Apr 28, 2027
- Completion
- Jan 28, 2028
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: QCZ484 + InclisiranQCZ484 + inclisiran, once on Day 1
- Active Comparator: QCZ484QCZ484 + inclisiran placebo, once on Day 1
- Active Comparator: InclisiranInclisiran + QCZ484 placebo, once on Day 1
- Placebo Comparator: PlaceboQCZ484 placebo + inclisiran placebo, once on Day 1
Primary Outcome Measure
Percent change from baseline of PCSK9 levels [ Time Frame: Baseline and Month 3 ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals
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