Combination therapy with QCZ484 and Inclisiran for hypertension with high cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, factorial Phase 2 trial to compare the pharmacodynamics, safety, and tolerability of QCZ484 alone, Inclisiran alone, their combination, or placebo in adults with primary hypertension and hypercholesterolemia. Participants are randomized on Day 1 to one of four groups and followed for up to 12 months, including a safety follow-up period and optional open-label extension after treatment. The study uses a structured screening process to confirm eligibility, including LDL-C and triglyceride thresholds, and stays within three study periods across the treatment and follow-up phases. The primary focus is on how the interventions affect lipid parameters and blood pressure while monitoring safety signals. Conduct sites are in Alabama and California under a lead sponsor and coordinator.

Why it matters

Who can join: the full rules

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

Where it's running

• G and L Research LLC
  Foley, Alabama, United States Recruiting
• The Center for Clinical Trials
  Saraland, Alabama, United States Recruiting
• Clinical Trials Research
  Lincoln, California, United States Recruiting
• Downtown L A Research Center Inc
  Los Angeles, California, United States Recruiting
• Valley Clinical Trials
  Northridge, California, United States Recruiting
• Flourish Medical Clinical Trials
  Boca Raton, Florida, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.