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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolaemia

In brief

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 facts

Study ID

NCT07610278

Run by

Novartis Pharmaceuticals

People needed

120

Starts

2026-05-29

Expected to finish

2028-02-03

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Other protocol inclusion/exclusion criteria may apply

Where it is running

• G and L Research LLC — Foley, Alabama, United States (enrolling)
• The Center for Clinical Trials — Saraland, Alabama, United States (enrolling)
• Clinical Trials Research — Lincoln, California, United States (enrolling)
• Downtown L A Research Center Inc — Los Angeles, California, United States (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)
• Flourish Medical Clinical Trials — Boca Raton, Florida, United States (enrolling)
• Clinical Research of Brandon LLC — Brandon, Florida, United States (enrolling)
• ALL Medical Research LLC — Cooper City, Florida, United States (enrolling)
• AMR Miami — Coral Gables, Florida, United States (enrolling)
• Universal Axon Clinical Research — Doral, Florida, United States (enrolling)
• East Coast Institute for Research — Jacksonville, Florida, United States (enrolling)
• Entrust Clinical Research — Miami, Florida, United States (enrolling)
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States (enrolling)
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States (enrolling)
• American Research Centers of FL — Pembroke Pines, Florida, United States (enrolling)
• East Coast Inst for Research LLC — Saint Augustine, Florida, United States (enrolling)
• East Coast Research — Canton, Georgia, United States (enrolling)
• Great Lakes Clinical Trials — Chicago, Illinois, United States (enrolling)
• AMR Chicago — Niles, Illinois, United States (enrolling)
• Alliance for Multispecialty Research — Wichita, Kansas, United States (enrolling)
• Monroe Research Llc — West Monroe, Louisiana, United States (enrolling)
• Anderson Medical Research — Ft. Washington, Maryland, United States (enrolling)
• Capitol Cardiology Associates — Lanham, Maryland, United States (enrolling)
• Monroe Biomedical Research — Monroe, North Carolina, United States (enrolling)
• Walker Family Care — Little River, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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