A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
- Conditions
- Hypertension
- Interventions
- Drug: lorundrostat Dose 2Drug: lorundrostat Dose 1Drug: Placebo
- Registration Number
- NCT05769608
- Lead Sponsor
- Mineralys Therapeutics Inc.
- Brief Summary
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.
- Detailed Description
This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.
The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 285
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 2 lorundrostat Dose 2 lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks Dose 1 lorundrostat Dose 1 lorundrostat Dose 1 once daily for 12 weeks Placebo Placebo Placebo once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) Baseline (Randomization) to Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in 24-hour average ABPM SBP at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Baseline to Week 4 Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo at Week 4 Change from baseline in 24-hour average ABPM SBP at Week 4 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Baseline to Week 4 Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 4 (within-subjects analysis) Baseline to Week 12 Change from baseline in 24-hour average ABPM SBP at Week 4, by number of AHT medications in the standardized AHT regimen (2 and 3) in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Baseline to Week 4 Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12 in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo Baseline to Week 12 Change from baseline in 24-hour average ABPM SBP at Week 12 by obesity status in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo Baseline to Week 12 Change from baseline in daytime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Baseline to Week 4 and Week 12 Change from baseline in AOBP SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Baseline to Week 4 and Week 12 Change from baseline in nighttime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo Baseline to Week 4 and Week 12 Change from baseline in 24-hour average ABPM SBP at Week 12, in subjects randomized to lorundrostat (pooled dosages) compared to subjects randomized to placebo Baseline to Week 12
Trial Locations
- Locations (103)
Cardiology, P.C. - Birmingham
🇺🇸Birmingham, Alabama, United States
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
🇺🇸Tuscon, 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
Nuovida Research Center Corp
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions, INC.
🇺🇸Orlando, Florida, United States
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
🇺🇸Pembroke, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
The Pierone Research Institute (Elligo Health Research)
🇺🇸Vero Beach, Florida, United States
Nephrology Associates, PC - Downtown Augusta
🇺🇸Augusta, Georgia, United States
Accel Research Sites
🇺🇸Decatur, Georgia, United States
Georgia Clinical Research, LLC
🇺🇸Lawrenceville, Georgia, United States
Randomize Now
🇺🇸Peachtree City, Georgia, United States
Alta Pharmaceutical Research Center
🇺🇸Peachtree Corners, Georgia, United States
Fellows Research Alliance, Inc
🇺🇸Savannah, Georgia, United States
Eagle Clinical Research
🇺🇸Chicago, Illinois, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
GenHarp Clinical Solutions
🇺🇸Evergreen Park, Illinois, United States
Southern Illinois School of Medicine
🇺🇸Springfield, Illinois, United States
Franciscan Physician Network-Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Indiana Clinical Research
🇺🇸Merrillville, Indiana, United States
The Research Group of Lexington, LLC
🇺🇸Lexington, Kentucky, United States
Advanced Internal Medicine, PLLC (Elligo Health Research)
🇺🇸Paducah, Kentucky, United States
Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Cambridge Clinical Trials
🇺🇸Alexandria, Louisiana, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
ActivMed Practices & Research, LLC
🇺🇸Methuen, Massachusetts, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Quality Clinical Research Inc. (QCR) - Omaha
🇺🇸Omaha, Nebraska, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Las Vegas Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Oasis Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Seacoast Kidney & Hypertension Specialist
🇺🇸Portsmouth, New Hampshire, United States
Albany Medical College Div of Community Endocrinology
🇺🇸Albany, New York, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Columbia University
🇺🇸New York, New York, United States
Marian David, MD, PC (Elligo Health Research)
🇺🇸New York, New York, United States
Triad Internal Medicine
🇺🇸Asheboro, North Carolina, United States
Asheville Clinical Trials (Elite Clinical Network)
🇺🇸Ashville, North Carolina, United States
Duke University Medical Center Heart Center Clinical Research Unit
🇺🇸Durham, North Carolina, United States
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
🇺🇸Greenville, North Carolina, United States
Lucas Research, Inc.
🇺🇸New Bern, North Carolina, United States
Iredell Memorial Hospital, Inc (Elligo Health Research)
🇺🇸Statesville, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Research Innovations (Elligo Health Research)
🇺🇸Beavercreek, Ohio, United States
Diabetes and Endocrinology Associates of Stark County, Inc.
🇺🇸Canton, Ohio, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Centricity Research (Aventiv Research) - Women's Health
🇺🇸Dublin, Ohio, United States
STAT Research
🇺🇸Springboro, Ohio, United States
Williamette Valley Clincial Studies
🇺🇸Eugene, Oregon, United States
AMS Cardiology
🇺🇸Horsham, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Accelerated Enrollment Solutions (AES)- Anderson
🇺🇸Anderson, South Carolina, United States
WR- Notus Clinical Trials, LLC
🇺🇸Charleston, South Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
Lifedoc Research
🇺🇸Memphis, Tennessee, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Vanderbilt University Medical Center (VUMC)
🇺🇸Nashville, Tennessee, United States
Elligo Health Research
🇺🇸Austin, Texas, United States
Punzi Medical Center
🇺🇸Carrollton, Texas, United States
David Turbay, MD, PLLC (Elligo Health Research)
🇺🇸El Paso, Texas, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Gulf Coast Clinical Research
🇺🇸Houston, Texas, United States
Medical Colleagues of Texas, LLP (Elligo Health Research)
🇺🇸Paris, Texas, United States
Synergy Groups Medical - Bissonet Site
🇺🇸Katy, Texas, United States
PRX Research - Mesquite
🇺🇸Mesquite, Texas, United States
ACRC Trials
🇺🇸Plano, Texas, United States
Clinical Investigations of Texas (CIT)
🇺🇸Plano, Texas, United States
Sun Research Institute (SRI) - San Antonio
🇺🇸San Antonio, Texas, United States
San Antonio Clinical Trials
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice (Elligo Health Research)
🇺🇸Sugar Land, Texas, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research
🇺🇸Suffolk, Virginia, United States