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

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 + Inclisiran
    QCZ484 + inclisiran, once on Day 1
  • Active Comparator: QCZ484
    QCZ484 + inclisiran placebo, once on Day 1
  • Active Comparator: Inclisiran
    Inclisiran + QCZ484 placebo, once on Day 1
  • Placebo Comparator: Placebo
    QCZ484 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

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