NCT07610278 · Novartis Pharmaceuticals
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, factorial design Phase 2 study to evaluate the how the drug affects the body, safety and how well patients handle the treatment of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Foley, Alabama
- Saraland, Alabama
- Lincoln, California
- Los Angeles, California
- Northridge, California
- Boca Raton, Florida
- Cooper City, Florida
- Coral Gables, Florida
- Doral, Florida
- Jacksonville, Florida
- Miami, Florida
- Miami Lakes, Florida
And 12 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations