Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
- Conditions
- Hypertension
- Interventions
- Drug: lorundrostat Dose 1Drug: PlaceboDrug: lorundrostat Dose 2
- Registration Number
- NCT06153693
- Lead Sponsor
- Mineralys Therapeutics Inc.
- Brief 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.
- Detailed Description
This study 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, one of which must be a thiazide or thiazide-like diuretic.
The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study. Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1083
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 lorundrostat Dose 1 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks Placebo Placebo Placebo once daily (QD) for 12 weeks Dose 2 lorundrostat Dose 2 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
- Primary Outcome Measures
Name Time Method Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Week 6
- Secondary Outcome Measures
Name Time Method Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QD with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo Week 12 Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Week 6 Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications Week 6 Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications Week 6 Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo
Change from baseline in AOBP SBP at Week 6 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo Week 6 Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at week 6 (within-subjects analysis) Week 12
Trial Locations
- Locations (184)
Advanced Cardiovascular, LLC - Alexander City Office
🇺🇸Alexander City, Alabama, United States
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
Pines Care Research Center, LLC
🇺🇸Pembroke Pines, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Clinical Research of West Florida (CRWF) - Clearwater
🇺🇸Tampa, Florida, United States
AES The Villages
🇺🇸The Villages, Florida, United States
Morehouse School of Medicine (MSM)
🇺🇸Atlanta, Georgia, United States
ClinCept, LLC
🇺🇸Columbus, Georgia, United States
Accel Research Sites- Decatur
🇺🇸Decatur, Georgia, United States
Georgia Clinical Research Center, Inc
🇺🇸Lawrenceville, Georgia, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Rocky Mountain Diabetes Center
🇺🇸Idaho Falls, Idaho, United States
Solaris Clinical Research (SCR)
🇺🇸Meridian, Idaho, United States
Synexus (Radiant Research, Inc) - Chicago
🇺🇸Chicago, Illinois, United States
Healthcare Research Network-Chicago, Illinois (Flossmoor) Location
🇺🇸Flossmoor, Illinois, United States
Koch Family Medicine, S.C.
🇺🇸Morton, Illinois, United States
Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine
🇺🇸Springfield, Illinois, United States
Investigators Research Group LLC
🇺🇸Brownsburg, Indiana, United States
Franciscan Physician Network
🇺🇸Indianapolis, Indiana, United States
ASHA Clinical Research- Munster, LLC
🇺🇸Munster, Indiana, United States
Synexus (Radiant Research, Inc) - Evansville
🇺🇸Newburgh, Indiana, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
🇺🇸Louisville, Kentucky, United States
Tulane Doctors - Heart & Vascular - Metairie
🇺🇸New Orleans, Louisiana, United States
The Alliance for Multispecialty Research LLC (AMR) - Louisiana
🇺🇸New Orleans, Louisiana, United States
Northwest Louisiana Nephrology, LLC - Shreveport
🇺🇸Shreveport, Louisiana, United States
Grace Research, LLC
🇺🇸Shreveport, Louisiana, United States
Boston Clinical Trials (BCT)
🇺🇸Boston, Massachusetts, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
Hattiesburg Clinic - Medisync Clinical Research
🇺🇸Petal, Mississippi, United States
Healthcare Research Network-Hazelwood
🇺🇸Hazelwood, Missouri, United States
Clinical Research Consultants (CRC) - Kansas City
🇺🇸Kansas City, Missouri, United States
Quality Clinical Research Inc. (QCR) - Omaha
🇺🇸Omaha, Nebraska, United States
Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD
🇺🇸Henderson, Nevada, United States
Sierra Clinical Research-Las Vegas
🇺🇸Las Vegas, Nevada, United States
Renown Regional Medical Center (Washoe Medical Center)
🇺🇸Reno, Nevada, United States
Synexus (Radiant Research, Inc) - New York
🇺🇸Jamaica, New York, United States
North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park
🇺🇸New Hyde Park, New York, United States
Columbia University
🇺🇸New York, New York, United States
Randolph Health Internal Medicine/ Triad Internal Medicine
🇺🇸Asheboro, North Carolina, United States
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
🇺🇸Greenville, North Carolina, United States
Physicians East, P.A. - Endocrinology
🇺🇸Greenville, North Carolina, United States
Carteret Medical Group - Morehead City
🇺🇸Morehead City, North Carolina, United States
Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC)
🇺🇸New Bern, North Carolina, United States
Diabetes & Endocrinology Associates of Stark County
🇺🇸Canton, Ohio, United States
Lynn Institute of Norman (LION Research)
🇺🇸Norman, Oklahoma, United States
Valley Kidney Specialists PC - Allentown Cedar Crest
🇺🇸Bethlehem, Pennsylvania, United States
Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location
🇺🇸Uniontown, Pennsylvania, United States
Chattanooga Medical Research (CMR), LLC
🇺🇸Chattanooga, Tennessee, United States
The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)
🇺🇸Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Punzi Medical Center and Trinity Hypertension Research Institute
🇺🇸Carrollton, Texas, United States
AES Dallas Fort Worth
🇺🇸Dallas, Texas, United States
Synergy Groups Medical
🇺🇸Houston, Texas, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States
Discovery Clinical Trials (DCT) - McAllen
🇺🇸McAllen, Texas, United States
Synergy Groups Medical - Missouri City
🇺🇸Missouri City, Texas, United States
North Texas Family Medicine (NTFM) - Plano Office
🇺🇸Plano, Texas, United States
Sun Research Institute (SRI) - San Antonio
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials (DCT) - San Antonio
🇺🇸San Antonio, Texas, United States
Global AES - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Velocity Clinical Research - Salt Lake City (Advanced Clinical Research)
🇺🇸West Jordan, Utah, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States
Eastern VA Medical School
🇺🇸Norfolk, Virginia, United States
Castle Hill Medical Centre
🇦🇺Castle Hill, New South Wales, Australia
Renal Research - Gosford
🇦🇺Gosford, New South Wales, Australia
University of Newcastle - John Hunter Hospital (JHH)
🇦🇺Waratah, New South Wales, Australia
University of the Sunshine Coast - Clinical Trials Centre
🇦🇺Sippy Downs, Queensland, Australia
South Coast Renal
🇦🇺Southport, Queensland, Australia
AusTrials - Taringa
🇦🇺Taringa, Queensland, Australia
AusTrials - Wellers Hill
🇦🇺Taringa, Queensland, Australia
Fusion Clinical Research
🇦🇺Adelaide, South Australia, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Dobney Hypertension Centre/ Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Austin Health - Heidelberg Repatriation Hospital
🇦🇺Heidelberg Heights, Australia
AusTrials - Sunshine
🇦🇺St Albans, Australia
Medical Center New Polyclinic Gabrovo Ltd.
🇧🇬Gabrovo, Bulgaria
Medical center Exacta Medica
🇧🇬Pleven, Bulgaria
Medical Center Hera EOOD - Sofia
🇧🇬Sofia, Bulgaria
ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology)
🇧🇬Sofia, Bulgaria
Medical Centre Zara-Med
🇧🇬Stara Zagora, Bulgaria
DCC 1 - Veliko Tarnovo
🇧🇬Veliko Tarnovo, Bulgaria
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Stephen S. Chow Medicine Professional Corporation
🇨🇦East York, Ontario, Canada
Centre Medical L'Acadie - Montreal
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Annecy Genevois (CHANGE) - Site d'Annecy -
🇫🇷Annecy, France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
🇫🇷Nîmes, France
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
🇫🇷Saint-Priest-en-Jarez, France
Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
🇫🇷Strasbourg, France
kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM)
🇩🇪Hannover, Lower Saxony, Germany
Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis
🇩🇪Mainz, Rhineland-Palatinate, Germany
kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD)
🇩🇪Dresden, Saxony, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Saxony, Germany
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
emovis GmbH
🇩🇪Berlin, Germany
Gemeinscharftspraxis Dres Jung - Deggingen
🇩🇪Deggingen, Germany
kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Karlsruhe GmbH (KFKA)
🇩🇪Karlsruhe, Germany
Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie
🇩🇪Leipzig, Germany
KfH Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum Klaus-Ketzler-Zentrum
🇩🇪Wiesbaden, Germany
Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)
🇮🇹Rozzano, Milan, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea Roma, Centro Ipertensione, UOC di Cardiologia
🇮🇹Roma, Rome, Italy
Istituto Nazionale di Riposo e Cura per Anziani (INRCA)
🇮🇹Ancona, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
🇮🇹Bologna, Italy
Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
🇮🇹Ferrara, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Azienda Sanitaria Locale 1 (ASL 1) - Ospedale Regionale San Salvatore
🇮🇹L'Aquila, Italy
Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" - Messina
🇮🇹Messina, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
AOU Policlinico di Modena - UO Cardiologia
🇮🇹Modena, Italy
Azienda Ospedaliera Universitaria (AOU) di Napoli
🇮🇹Napoli, Italy
Fondazione IRCCS Policlinico San Matteo, - SC Ematologia, Dipartimento Oncoematologico
🇮🇹Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
IRCCS San Raffaele
🇮🇹Rome, Italy
Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)
🇳🇱Nijmegen, Gelderland, Netherlands
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
🇳🇱Amsterdam, North Holland, Netherlands
Albert Schweitzer Ziekenhuis - Sliedrecht
🇳🇱Dordrecht, South Holland, Netherlands
Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU
🇳🇱Utrecht, Netherlands
Diamond Clinic Specjalistyczne Poradnie Lekarskie
🇵🇱Krakow, Malopolskie, Poland
Velocity Lublin
🇵🇱Lubin, Polska, Poland
Velocity Skierniewice Sp. z o.o
🇵🇱Skierniewice, Polska, Poland
ETG Network - Warszawa (European Trial Group)
🇵🇱Warsaw, Polska, Poland
Etyka OÅ>rodek BadaÅ" Klinicznych
🇵🇱Olsztyn, Warminsko-Mazurskie, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Silmedic Sp. z o.o
🇵🇱Katowice, Poland
FutureMeds Sp. z o.o. Futuremeds Olsztyn
🇵🇱Olsztyn, Poland
FutureMeds Sp. z o.o. FutureMeds Lodz
🇵🇱Łódź, Poland
Latin Clinical Trial Center Inc. (LCTC)
🇵🇷San Juan, Puerto Rico
Spitalul Clinic Judetean de Urgenta Tg. Mures
🇷🇴Targu Mures, Mures, Romania
Centrul Medicali's Timisoara
🇷🇴Timişoara, Timis, Romania
Centrul Medical Unirea SRL Brasov (Regina Maria)
🇷🇴Brasov, Romania
Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
🇷🇴Bucuresti, Romania
Angiocare S.R.L. (Spitalul Ares Cluj-Napoca)
🇷🇴Cluj-Napoca, Romania
Spitalul Clinic Municipal Filantropia Craiova
🇷🇴Craiova, Romania
Spitalul Clinic Judetean de Urgenta Bihor
🇷🇴Oradea, Romania
S.C Materna Care SRL Timisoara (Regina Maria)
🇷🇴Timisoara, Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
🇷🇴Timisoara, Romania
Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
🇪🇸Badajoz, Spain
Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM)
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario Virgen de las Nieves (HUVN)
🇪🇸Granada, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) - Instituto de Investigacion Sanitaria (IIS)
🇪🇸Madrid, Spain
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
🇪🇸Santiago De Compostela, Spain
Instituto de Investigacion Sanitaria (INCLIVA)
🇪🇸Valencia, Spain
Fowey River Practice - Fowey Surgery
🇬🇧Fowey, Great Britain, United Kingdom
Queen Mary University of London (QMUL) - Barts and The London School of Medicine and Dentistry - William Harvey Research Institute (WHRI) - William Harvey Heart Centre (WHHC)
🇬🇧London, Great Britain, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, Great Britain, United Kingdom
The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health
🇬🇧Torpoint, Great Britain, United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH)
🇬🇧Canterbury, Kent, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Birmingham Regional Severe Asthma Service (BRSAS)
🇬🇧Birmingham, United Kingdom
East Kent Hospitals University NHS Foundation Trust
🇬🇧Canterbury, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
🇬🇧Carshalton, United Kingdom
Rowden Surgery Rowden Medical Partnership
🇬🇧Chippenham, United Kingdom
NHS Greater Glasgow and Clyde (NHSGGC)
🇬🇧Glasgow, United Kingdom
Newquay Health Centre
🇬🇧Newquay, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
🇬🇧Sheffield, United Kingdom
FutureMeds - Stockton-on-Tees
🇬🇧Stockton-on-Tees, United Kingdom