CompletedPhase 2

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

United States60 participantsStarted 2023-12-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void
✓. At Screening, eGFRs of ≥30 mL/min/1.73 m2
✓. At Screening, AOBP SBP of 135-180 mmHg, inclusive
✓. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
✓. At Screening, body mass index (BMI) of \>18 kg/m2

Exclusion criteria

✕. Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
✕. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only)
✕. At Screening, serum potassium \>5.0 mmol/L
✕. History of clinically significant hyponatremia within 1 year prior to Screening
✕. 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

What they're measuring

Placebo-adjusted change from baseline in automated office blood pressure (AOBP) systolic blood pressure (SBP) at Week 4

Timeframe: baseline to Week 4

Incidence and severity of adverse events (AEs)

Timeframe: baseline to Week 14

Trial details

NCT IDNCT06150924

SponsorMineralys Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Chronic Kidney Disease trials