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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT06153693

Run by

Mineralys Therapeutics Inc.

People needed

1083

Starts

2023-11-22

Expected to finish

2025-01-24

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Women who are pregnant, plan to become pregnant, or are breastfeeding
• 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
• 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.
• History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

Where it is running

• Central Research Associates, Inc — Birmingham, Alabama, United States
• Cardiology, P.C. — Birmingham, Alabama, United States
• Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location — Birmingham, Alabama, United States
• G & L Research LLC - Foley — Foley, Alabama, United States
• Accel Research Sites (ARS) - Birmingham Clinical Research Unit — Vestavia Hills, Alabama, United States
• Del Sol Research — Tucson, Arizona, United States
• Entertainment Medical Group, Inc. — Beverly Hills, California, United States
• Amicis Research Center - Granada Hills — Granada Hills, California, United States
• Amicis Research Center - Northridge — Granada Hills, California, United States
• Marvel Clinical Research, LLC — Huntington Beach, California, United States
• Amicis Research Center — Northridge, California, United States
• Pasadena Clinical Trials — Pasadena, California, United States
• Empire Clinical Research (ECR) — Pomona, California, United States
• Clinical Trials Research (CTR) - Sacramento — Sacramento, California, United States
• North America Research Institute — San Dimas, California, United States
• Amicis Research Center - Valencia — Valencia, California, United States
• CMR of Greater New Haven — Hamden, Connecticut, United States
• Chase Medical Research, LLC - Hamden — Waterbury, Connecticut, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville — Jacksonville, Florida, United States
• Nuovida Research Center Corp — Miami, Florida, United States
• Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center — Orlando, Florida, United States
• AES Orlando — Orlando, Florida, United States
• Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) — Pembroke Pines, Florida, United States
• Advanced Cardiovascular, LLC - Alexander City Office — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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