1. Trial Details/Purpose

Approximately 47% of U.S. adults, or 116 million people, have hypertension, with 1 in 2 adults aged 60+ affected. While 80% are aware of their condition, only 1 in 4 have it under control, and 54% of those aware manage it effectively. Higher risk groups include African Americans, older adults, and those with obesity, diabetes, or a family history. The prevalence has increased due to aging, lifestyle, and obesity.  This clinical trial is designed to evaluate a new medication, QCZ484, for treating adults with mild to moderate high blood pressure. The study will involve approximately 380 participants and will last between 13.5 to 19.5 months.​

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2.  Inclusion Criteria

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• Age and Consent: Participants should be between 18 and 75 years old and must provide written informed consent.

• Hypertension Diagnosis: Individuals must have a diagnosis of high blood pressure.

• Current Treatment Status: Participants can either be new to hypertension treatment or currently taking up to two blood pressure medications, with the ability to discontinue these medications for four weeks if required.

• Blood Pressure Levels: Before starting the study, participants not on hypertension medication should have an average seated systolic blood pressure (SBP) of 140 mmHg or higher, measured in a clinical setting, and a 24-hour average SBP between 130 mmHg and less than 160 mmHg, measured using ambulatory blood pressure monitoring.

• Compliance: Participants must be able to understand and follow the study procedures.

 

3. Exclusion Criteria

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• Secondary Hypertension: Individuals with high blood pressure caused by other medical conditions, such as kidney disease or hormonal disorders, are excluded.

• Orthostatic Hypotension: Those who experience a significant drop in blood pressure upon standing are not eligible.

• Laboratory Findings: Participants with certain lab results outside the acceptable range, such as high potassium levels or significantly reduced kidney function, will be excluded.

• Liver Disease: Individuals with evidence of liver disease, indicated by elevated liver enzymes or bilirubin levels, are excluded.

• Recent Participation in Other Studies: Those who have received an investigational drug within the last 30 days or five half-lives (whichever is longer) before randomization are not eligible.

• Medical Conditions Requiring Specific Medications: Participants with conditions necessitating continuous use of certain blood pressure medications that cannot be paused for the study duration are excluded.

• Heart Failure History: Individuals with a history of heart failure classified as New York Heart Association Class II-IV are excluded.

• Beta-Blocker Use: Participants currently taking beta-blockers who cannot discontinue them for the study duration are not eligible.

• Unstable Medication Regimen: Those with recent changes in specific medications, such as SGLT2 inhibitors, within 30 days prior to screening are excluded.

• Use of Prohibited Medications: Participants unable to comply with the study's medication restrictions are not eligible.

• Previous siRNA Exposure: Individuals who have used or plan to use small interfering RNA treatments during the study or have prior exposure to any siRNA are excluded.

• Medication Intolerance: Those with a history of intolerance to ACE inhibitors or ARBs are not eligible.

• Diabetes Status: Participants with Type 1 diabetes, uncontrolled Type 2 diabetes (HbA1c >9%), or newly diagnosed diabetes during screening are excluded.

• Cardiac Arrhythmias: Individuals with significant irregular heartbeats or certain types of heart blockages within six months prior to screening are excluded.

• Atrial Fibrillation: Those with permanent or persistent atrial fibrillation are not eligible.

• Valvular Heart Disease: Participants with significant heart valve diseases are excluded.

• Recent Cardiac Events: Individuals who have experienced a heart attack, unstable chest pain, or undergone certain heart procedures within 12 months prior to screening are excluded.

• Stroke History: Those with any history of stroke or transient ischemic attack are not eligible.

• Infectious Diseases: Participants with known HIV, chronic hepatitis B, or hepatitis C infections are excluded.

• Organ Transplantation: Individuals with a history of or plans for liver or kidney transplantation during the study, or those under immunosuppressive treatment, are not eligible.

• Renal Denervation History: Participants who have undergone a renal denervation procedure are excluded.

• Arm Size Limitation: Those with a mid-arm circumference of 44 cm or more, which may affect accurate blood pressure measurements, are not eligible.

• Recent Severe Hypertension Events: Individuals with a history of hospitalization for severe uncontrolled hypertension within 12 months prior to screening are excluded.

• Night Shift Workers: Participants who work night shifts are not eligible.

• Other Medical Conditions: Individuals with any other disease that, in the investigator's opinion, could interfere with study compliance, data interpretation, or participant safety are excluded.

• Recent Malignancy: Participants with a history of cancer, other than localized skin or prostate cancer, within the past three years are excluded.

• Substance Abuse History: Individuals with a history of drug abuse or alcohol dependency are not eligible.

• Multiple Drug Allergies: Those with a history of hypersensitivity to multiple drugs or allergic reactions to specific compounds used in the study are excluded.

• Comprehension and Compliance Issues: Participants lacking the ability to understand or follow instructions, or those deemed unlikely to comply with the study protocol, are not eligible.

• Recent Illness: Individuals with a significant illness within seven days prior to randomization are excluded.

• Pregnancy and Nursing: Pregnant or breastfeeding women, or those planning to become pregnant, are not eligible. Women of childbearing potential must use highly effective contraception during the study and for six months after.

• Male Participants: Men with partners of childbearing potential must use condoms for 48 hours after each administration of the study drug, and their partners should also use effective contraception during this period.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location​

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     Huntington Park​​​​​​