Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria

This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor \[ASI\]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.

Major Inclusion Criteria: 1. At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void 2. At Screening, eGFRs of ≥30 mL/min/1.73 m2 3. At Screening, AOBP SBP of 135-180 mmHg, inclusive 4. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening 5. At Screening, body mass index (BMI) of \>18 kg/m2 Major Exclusion Criteria: 1. Subjects with known hypersensitivity to lorundrostat or any of its respective excipients 2. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only) 3. At Screening, serum potassium \>5.0 mmol/L 4. History of clinically significant hyponatremia within 1 year prior to Screening 5. Use of epithelial sodium channel (ENaC) inhibitors or Mineralocorticoid receptor antagonist (MRAs), including, but not limited to amiloride, triamterene, spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visit and during study participation. With the exception of MRAs in primary aldosteronism 6. Medical history of kidney disease related to autoimmune diseases (lupus, anti-neutrophil cytoplasmic antibody \[ANCA\] vasculitis), multiple myeloma or other known paraproteins, infiltrative diseases of the kidney, obstructive nephropathy, cystic kidney diseases, and renal transplantation 7. Medical history of advanced liver disease, including cirrhosis 8. Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy 9. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>10% (\>86 mmol/mol) at Screening