Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension
NCT ID: NCT06153693
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1083 participants
INTERVENTIONAL
2023-11-22
2025-01-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo once daily (QD) for 12 weeks
Placebo
Placebo once daily (QD) for 12 weeks
Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
lorundrostat Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
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
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
Interventions
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Placebo
Placebo once daily (QD) for 12 weeks
lorundrostat Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
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
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Taking between 2 and 5 AHT medications,
4. History of hypertension lasting at least 6 months prior to Screening
5. Body mass index (BMI) of ≥18 kg/m2 at Screening
Exclusion Criteria
2. 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
3. eGFR \<45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
4. Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
5. Serum sodium \<135 mmol/L (corrected for hyperglycemia) at Screening.
6. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.
18 Years
ALL
No
Sponsors
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Mineralys Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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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)
Hanover, 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, Lesser Poland Voivodeship, 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, Warmian-Masurian Voivodeship, 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 Lodz
Lodz, , Poland
FutureMeds Sp. z o.o. Futuremeds Olsztyn
Olsztyn, , Poland
Latin Clinical Trial Center Inc. (LCTC)
San Juan, , Puerto Rico
Spitalul Clinic Judetean de Urgenta Tg. Mures
Târgu Mureş, Mureș County, Romania
Centrul Medicali's Timisoara
Timișoara, Timiș County, Romania
Centrul Medical Unirea SRL Brasov (Regina Maria)
Brasov, , Romania
Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , 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)
Timișoara, , Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
Timișoara, , 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
Countries
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References
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Saxena M, Laffin L, Borghi C, Fernandez Fernandez B, Ghali JK, Kopjar B, Polu K, Roger SD, Slingsby BT, Strutz F, Vogt L, Weir MR, Rodman D; Launch-HTN Investigators. Lorundrostat in Participants With Uncontrolled Hypertension and Treatment-Resistant Hypertension: The Launch-HTN Randomized Clinical Trial. JAMA. 2025 Aug 5;334(5):409-418. doi: 10.1001/jama.2025.9413.
Other Identifiers
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MLS-101-301
Identifier Type: -
Identifier Source: org_study_id
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