Phase 2
N=59
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
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT06150924 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Jun 2026
Primary outcome: Primary: Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4 — -1.755; -9.253 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD (Drug); Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mineralys Therapeutics Inc.
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4 |
-1.755; -9.253 | — |
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.
Eligibility Criteria
Major 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
Major 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
- 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
- Medical history of advanced liver disease, including cirrhosis
- Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
- Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >10% (>86 mmol/mol) at Screening
Data sourced from ClinicalTrials.gov (NCT06150924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.