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

Conditions

• Hypercholesterolaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• QCZ484 — DRUG
  QCZ484 once on Day 1
• Inclisiran — DRUG
  Inclisiran once on Day 1
• QCZ484 placebo — DRUG
  QCZ484 placebo once on Day 1
• Inclisiran placebo — DRUG
  Inclisiran 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

First listed

May 27, 2026

Start date

May 29, 2026

Status verified

Jul 2026

Primary completion

Apr 28, 2027

Completion

Feb 3, 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

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals

Locations (29)

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