Lorundrostat for High Blood Pressure
Recruiting at185 trial locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Mineralys Therapeutics Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests lorundrostat, a medication that lowers blood pressure by blocking an enzyme involved in hormone production. It targets patients with high blood pressure not controlled by 2 to 5 other medications.
Research Team
Eligibility Criteria
This trial is for adults over 18 with uncontrolled and resistant high blood pressure, despite taking 2-5 blood pressure medications. Participants must have a history of hypertension for at least 6 months, an office-based blood pressure reading within certain ranges, and a BMI of ≥18 kg/m2.Inclusion Criteria
Taking between 2 and 5 AHT medications
Body mass index (BMI) of ≥18 kg/m2 at Screening
Are you taking at least 2 to 5 medications for your high blood pressure?
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Exclusion Criteria
Any current or known nervous system conditions? (ex. Alzheimers, cerebral palsy, epilepsy, MS, and Parkinson's)
Any hospitalizations to treat severely elevated blood pressure in the last year?
Are you a current night shift worker or night shift worker for more than 14 days continuously?
See 1 more
Treatment Details
Interventions
- Lorundrostat (Aldosterone Synthase Inhibitor)
Trial OverviewThe trial is testing the effectiveness of lorundrostat at two different doses compared to a placebo in lowering blood pressure. Lorundrostat is an aldosterone synthase inhibitor. This Phase 3 study involves patients who are already on multiple anti-hypertensive drugs.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 2Experimental Treatment1 Intervention
50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria
Group II: Dose 1Experimental Treatment1 Intervention
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo once daily (QD) for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mineralys Therapeutics Inc.
Lead Sponsor
Trials
6
Recruited
3,100+
Founded
2019
Headquarters
Radnor, USA
Known For
Hypertension treatments
Top Products
Lorundrostat