High Blood Pressure Self-Scheduler

Basic Criteria 

• Males or females ages 18 – 75 years old with mild to moderate hypertension. 

• Must be diagnosed with high blood pressure (hypertension) 

• Must meet ONE of the following criteria: 

• • Not currently taking any blood pressure medications, OR 

• • Taking no more than 2 blood pressure medications and able to stop them safely for 4 weeks under medical supervision 

Answers Must Be NO 

• Are you currently pregnant, breastfeeding, or planning to become pregnant in the next 18 months? 

• Have you ever had a liver or kidney transplant, or are you planning one during the study? 

• Are you currently taking any medications that suppress your immune system? 

• Have you ever had a renal denervation procedure (a procedure where nerves in the kidneys are treated to lower blood pressure)?  

• Is your high blood pressure caused by other health problem such as kidney disease, hormone problems, Cushing syndrome, issues with your blood vessels or heart, or due to history of moderate-to-severe obstructive sleep apnea not treated with face mask or nasal device? 

• Do you work night shifts? 

• Do you have a history of drug abuse or alcohol dependency?  

• Do you have HIV, Hepatitis B, or Hepatitis C?  

• Do you have Type 1 diabetes (the kind that requires insulin from diagnosis)? 

• Do you have Type 2 diabetes with an A1C greater than 9%, or were you newly diagnosed with diabetes during screening? Note: If you have well-controlled Type 2 diabetes, that’s okay. 

• If you’re taking an SGLT2 inhibitor (diabetes medication like Jardiance, Farxiga, Invokana), have you changed your dose in the past 30 days? 

• Are you currently taking beta-blockers (such as metoprolol, atenolol, carvedilol) that you cannot stop for the study? 

• Do you have any medical condition besides high blood pressure that requires you to take an ACE inhibitor or ARB that cannot be stopped? E.g., heart failure or kidney disease requiring these specific medications. 

• Have you ever had a bad reaction or intolerance to ACE inhibitors (medications ending in “-pril” like lisinopril) or ARBs (medications ending in “-sartan” like losartan)? 

• Within the past 12 months, have you had any of the following:  

• • Heart attack or unstable chest pain (angina) 

• • Any heart procedure such as stent placement, angioplasty, or bypass surgery 

• • Hospitalization for dangerously high blood pressure with organ damage or a hypertensive emergency 

• Have you ever had any type of stroke or mini stroke (TIA)? 

• Do you have heart failure that causes symptoms with activity or at rest? For example: 

• • Getting short of breath walking one or two blocks 

• • Getting short of breath climbing stairs 

• • Needing to sleep propped up on pillows 

• • Swelling in your legs 

• Do you have permanent or persistent atrial fibrillation (irregular heartbeat that doesn’t come and go)? Note: If AFib comes and goes (paroxysmal), that’s okay. 

• Do you have significant problems with your heart valves?  

• Within the past 6 months, have you had serious heart rhythm problems such as ventricular tachycardia or high-grade heart block? Note: Having a pacemaker is okay. 

• Are you currently using or have you previously used any siRNA medications (small interfering RNA therapy)?  

• Are you taking any of the following medications that cannot be stopped:  

• • Aliskiren (Tekturna) – a direct renin inhibitor 

• • Eplerenone (Inspra) or spironolactone (Aldactone) – specific types of diuretics 

• • Other medications listed in the protocol’s prohibited medication list 

• Do you have an estimated kidney function (eGFR) of 30 or less (stage 4 or 5)?  

• Is your upper arm circumference 44 cm or larger (about 17 inches)? This is important because the blood pressure cuff needs to fit properly. 

• Within the past 3 years, have you had any cancer (except non-melanoma skin cancer or localized prostate cancer that was treated)? 

• Do you have a history of severe allergic reactions to multiple drugs, or any allergic reaction to oligonucleotides or GalNac (components in the study medication)?  

• Have you been sick with any significant illness in the past 7 days? 

• Do you have any other disease or medical condition that would make it difficult to participate in this study or might affect your safety?  

• Are you currently enrolled in another study or have received any investigational products in the past 30 days? 

Answers Must be YES 

• Can you understand and follow study instructions, attend all required visits?  

• Must be willing to wear portable ABPM monitor and BP cuff for 24 hours at screening, month 3, 6 and 12 of the study and return to site 1 day prior to those scheduled visits to have monitor and cuff placed. 

• For women who can become pregnant: are you willing to use highly effective birth control during the study and for 6 months after? Note: if using pills must be stable on the same pill for at least 3months. 

• • Combined (estrogen and progestogen) hormonal contraception; oral, intravaginal or transdermal. 

• • Progestogen-only hormonal contraception; oral, injectable or implantable. 

• • IUD, IUS 

• For women who cannot become pregnant do you meet one on the following: 

• • Female sterilization; have had surgical bilateral oophorectomy, total hysterectomy, bilateral tubal occlusion, or bilateral tubal ligation at least six weeks before taking study treatment. 

• • Post-menopause for at least 12 months  

• • Vasectomized male partner at least 6 months prior to first visit  

• For male participants with female partners who can become pregnant; are you willing to use condoms 48hrs prior to study treatment and have your partner on a highly effective method of contraception throughout the study? 

Additional criteria may apply