A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

Key facts

Study ID

NCT05769608

Run by

Mineralys Therapeutics Inc.

People needed

285

Starts

2023-03-13

Expected to finish

2025-01-15

Last updated by the study team

2026-01-20

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
• At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
• 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg
• Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
• BMI of 18-40 kg/m2 inclusive at Screening

You may not qualify if…

• eGFR <45 mL/min/1.73 m2 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 at Screening
• History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
• Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening

Where it is running

• University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program — Birmingham, Alabama, United States
• Chandler Clinical Trials — Chandler, Arizona, United States
• Brown Road Family Medicine — Mesa, Arizona, United States
• Scottsdale Clinical Trials (Elite Clinical Network) — Scottsdale, Arizona, United States
• Fiel Family & Sports Medicine — Tempe, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Del Sol Research Management, LLC — Tucson, Arizona, United States
• The Medical Research Group Inc. — Fresno, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• Northridge Clinical Trials — Northridge, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Triwest Research Associates — San Diego, California, United States
• San Jose Clinical Trials — San Jose, California, United States
• Blue Coast Research Center — Vista, California, United States
• Accelerated Enrollment Solutions (AES)- Vista — Vista, California, United States
• Delta Waves, Inc. — Colorado Springs, Colorado, United States
• CMR of Greater New Haven — Hamden, Connecticut, United States
• Indago Research & Health Center, Inc. — Hialeah, Florida, United States
• Clinical Neuroscience Solutions, Inc (Jacksonville) — Jacksonville, Florida, United States
• Reserka, LLC — Miami, Florida, United States
• Cardiology, P.C. - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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