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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mineralys Therapeutics Inc.

Criteria

Inclusion Criteria:

1. At least 18 years of age at the time of signing the informed consent form (ICF)

2. 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

3. Taking between 2 and 5 AHT medications,

4. History of hypertension lasting at least 6 months prior to Screening

5. Body mass index (BMI) of ≥18 kg/m2 at Screening

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breastfeeding

2. 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

3. eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

4. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization

5. Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening.

6. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.