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

ConditionHypercholesterolaemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Symptomatic orthostatic hypotension.

Treatment with certain medications and/or unable to comply with prohibited medications requirements.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: QCZ484 + InclisiranExperimental treatment 2 interventions
Group B: QCZ484Active comparator 1 intervention
Group C: InclisiranActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percent change from baseline of PCSK9 levels

Percent (%) change from baseline of PCSK9 levels for QCZ484 + Inclisiran at Month 3

Time frame
Baseline and Month 3
2

Percent change from baseline of AGT levels

Percent (%) change from baseline of AGT levels for QCZ484 + Inclisiran at Month 3

Time frame
Baseline and Month 3

Secondary outcomes

1

Change from baseline of systolic blood pressure

Change from baseline of systolic blood pressure for QCZ484 + Inclisiran at Month 3 and 6.

Time frame
Baseline, Month 3 and Month 6
2

Change from baseline of LDL-C levels

Change from baseline of LDL-C levels for QCZ484 + Inclisiran at Month 3 and 6.

Time frame
Baseline, Month 3 and Month 6
3

Number of participants with Treatment-emergent adverse event and abnormal changes in laboratory parameters, vital signs and other safety assessments

Number of participants with treatment-emergent adverse event, abnormal changes in laboratory parameters, vital signs and other safety assessments up to Month 12.

Time frame
Up to month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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