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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Hypercholesterolaemia

Treatments: Drug: Inclisiran placebo; Drug: QCZ484 placebo; Drug: QCZ484; Drug: Inclisiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT07610278

CHDY015A12201

Details and patient eligibility

About

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.

Full description

The study will last up to 12 months and has three periods:

• Eligibility will be assessed during the screening period including 2 screening visits. Some eligibility criteria will be confirmed at the Baseline/Randomization visit.
• Eligible participants will be randomized to receive a combination of QCZ484 and inclisiran, QCZ484, inclisiran or placebo once on Day 1 at the Baseline/Randomization visit.
• Afterwards, participants will enter the safety follow-up period. Eligible participants who complete the treatment period have the option to participate in an open-label extension study instead of entering the safety follow-up period.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Symptomatic orthostatic hypotension.
• Treatment with certain medications and/or unable to comply with prohibited medications requirements.

Other protocol inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

QCZ484 + Inclisiran

Experimental group

Description:

QCZ484 + inclisiran, once on Day 1

Treatment:

Drug: Inclisiran

Drug: QCZ484

QCZ484

Active Comparator group

Description:

QCZ484 + inclisiran placebo, once on Day 1

Treatment:

Drug: QCZ484

Inclisiran

Active Comparator group

Description:

Inclisiran + QCZ484 placebo, once on Day 1

Treatment:

Drug: Inclisiran

Placebo

Placebo Comparator group

Description:

QCZ484 placebo + inclisiran placebo, once on Day 1

Treatment:

Drug: QCZ484 placebo

Drug: Inclisiran placebo