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

NCT07610278 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CHDY015A12201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypercholesterolaemia

Keywords

Hypertension; hypercholesterolemia; siRNA; inclisiran; QCZ484; randomized; double-blind; Phase 2; pharmacodynamics; AGT; PCSK9

Outcome Measures

Primary Outcomes (2)

• Percent change from baseline of PCSK9 levels

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

  Baseline and Month 3

• Percent change from baseline of AGT levels

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

  Baseline and Month 3

Secondary Outcomes (3)

• Change from baseline of systolic blood pressure

  Baseline, Month 3 and Month 6

• Change from baseline of LDL-C levels

  Baseline, Month 3 and Month 6

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

  Up to month 12

Study Arms (4)

QCZ484 + Inclisiran

EXPERIMENTAL

QCZ484 + inclisiran, once on Day 1

Drug: QCZ484; Drug: Inclisiran

QCZ484

ACTIVE COMPARATOR

QCZ484 + inclisiran placebo, once on Day 1

Drug: QCZ484

Inclisiran

ACTIVE COMPARATOR

Inclisiran + QCZ484 placebo, once on Day 1

Drug: Inclisiran

Placebo

PLACEBO COMPARATOR

QCZ484 placebo + inclisiran placebo, once on Day 1

Drug: QCZ484 placebo; Drug: Inclisiran placebo

Interventions

QCZ484 DRUG

QCZ484 once on Day 1

QCZ484; QCZ484 + Inclisiran

Inclisiran DRUG

Inclisiran once on Day 1

Also known as: KJX839, Leqvio

Inclisiran; QCZ484 + Inclisiran

QCZ484 placebo DRUG

QCZ484 placebo once on Day 1

Placebo

Inclisiran placebo DRUG

Inclisiran placebo once on Day 1

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hypercholesterolemia; Hypertension

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): January 28, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share