Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

Prior treatment

• Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
• History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

Lab values

• eGFR \<45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
• Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
• Serum sodium \<135 mmol/L (corrected for hyperglycemia) at Screening.

Other

• Women who are pregnant, plan to become pregnant, or are breastfeeding

• At least 18 years of age at the time of signing the informed consent form (ICF)
• At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
• Taking between 2 and 5 AHT medications,
• History of hypertension lasting at least 6 months prior to Screening
• Body mass index (BMI) of ≥18 kg/m2 at Screening