Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

April 28, 2026 updated by: Mineralys Therapeutics Inc.

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

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.

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1083

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Heidelberg Heights, Australia, 3081
    - Austin Health - Heidelberg Repatriation Hospital
  - St Albans, Australia, VIC 3021
    - AusTrials - Sunshine
- New South Wales
  - Castle Hill, New South Wales, Australia, 2154
    - Castle Hill Medical Centre
  - Gosford, New South Wales, Australia, 2250
    - Renal Research - Gosford
  - Waratah, New South Wales, Australia, 2298
    - University of Newcastle - John Hunter Hospital (JHH)
- Queensland
  - Sippy Downs, Queensland, Australia, 4556
    - University of the Sunshine Coast - Clinical Trials Centre
  - Southport, Queensland, Australia, 4215
    - South Coast Renal
  - Taringa, Queensland, Australia, 4068
    - AusTrials - Taringa
  - Taringa, Queensland, Australia, 4068
    - AusTrials - Wellers Hill
- South Australia
  - Adelaide, South Australia, Australia
    - Fusion Clinical Research
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Royal Hobart Hospital
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Dobney Hypertension Centre/ Royal Perth Hospital
Bulgaria
- - Gabrovo, Bulgaria, 5300
    - Medical Center New Polyclinic Gabrovo Ltd.
  - Pleven, Bulgaria, 5800
    - Medical center Exacta Medica
  - Sofia, Bulgaria, 1510
    - Medical Center Hera EOOD - Sofia
  - Sofia, Bulgaria, 1592
    - ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology)
  - Stara Zagora, Bulgaria, 6000
    - Medical Centre Zara-Med
  - Veliko Tarnovo, Bulgaria, 5000
    - DCC 1 - Veliko Tarnovo
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2G3
    - University of Alberta
- Ontario
  - East York, Ontario, Canada, M4C 5T2
    - Stephen S. Chow Medicine Professional Corporation
- Quebec
  - Montreal, Quebec, Canada, H4N 2W2
    - Centre Medical L'Acadie - Montreal
France
- - Annecy, France, 74011
    - Centre Hospitalier Annecy Genevois (CHANGE) - Site d'Annecy -
  - Bordeaux, France, 33000
    - Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre
  - Nîmes, France, 30029
    - Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
  - Saint-Priest-en-Jarez, France, 42270
    - Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
  - Strasbourg, France, 67091
    - Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
Germany
- - Berlin, Germany, 10629
    - emovis GmbH
  - Berlin, Germany, 10117
    - Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
  - Deggingen, Germany, 73326
    - Gemeinscharftspraxis Dres Jung - Deggingen
  - Karlsruhe, Germany
    - kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Karlsruhe GmbH (KFKA)
  - Leipzig, Germany, 04103
    - Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie
  - Wiesbaden, Germany, 65191
    - KfH Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum Klaus-Ketzler-Zentrum
- Lower Saxony
  - Hanover, Lower Saxony, Germany, 30159
    - kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM)
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Germany, 55116
    - Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis
- Saxony
  - Dresden, Saxony, Germany, 01069
    - kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD)
  - Leipzig, Saxony, Germany, 04289
    - Herzzentrum Leipzig
Italy
- - Ancona, Italy, 60127
    - Istituto Nazionale di Riposo e Cura per Anziani (INRCA)
  - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
  - Brescia, Italy, 251123
    - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
  - Ferrara, Italy, 44124
    - Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
  - Genova, Italy, 16132
    - IRCCS Ospedale Policlinico San Martino
  - L’Aquila, Italy, 67100
    - Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore
  - Messina, Italy, 98125
    - Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" - Messina
  - Milan, Italy, 20162
    - ASST Grande Ospedale Metropolitano Niguarda
  - Modena, Italy, 41121
    - AOU Policlinico di Modena - UO Cardiologia
  - Naples, Italy, 80131
    - Azienda Ospedaliera Universitaria (AOU) di Napoli
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo, - SC Ematologia, Dipartimento Oncoematologico
  - Pisa, Italy, 56126
    - Azienda Ospedaliero Universitaria Pisana
  - Rome, Italy, 00163
    - IRCCS San Raffaele
- Milan
  - Rozzano, Milan, Italy, 20089
    - Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)
- Rome
  - Roma, Rome, Italy, 00189
    - Azienda Ospedaliero-Universitaria Sant'Andrea Roma, Centro Ipertensione, UOC di Cardiologia
Netherlands
- - Utrecht, Netherlands, 3508 GA
    - Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525 GA
    - Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)
- North Holland
  - Amsterdam, North Holland, Netherlands, 1105 AZ
    - Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
- South Holland
  - Dordrecht, South Holland, Netherlands
    - Albert Schweitzer Ziekenhuis - Sliedrecht
Poland
- - Katowice, Poland, 40-027
    - Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
  - Katowice, Poland, 40-282
    - Silmedic sp. z o.o
  - Lodz, Poland
    - FutureMeds Sp. z o.o. FutureMeds Lodz
  - Olsztyn, Poland, 10-010
    - FutureMeds Sp. z o.o. Futuremeds Olsztyn
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-559
    - Diamond Clinic Specjalistyczne Poradnie Lekarskie
- Polska
  - Lubin, Polska, Poland, 20-362
    - Velocity Lublin
  - Skierniewice, Polska, Poland, 96-100
    - Velocity Skierniewice Sp. z o.o
  - Warsaw, Polska, Poland, 02-677
    - ETG Network - Warszawa (European Trial Group)
- Warmian-Masurian Voivodeship
  - Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-117
    - Etyka OÅ>rodek BadaÅ" Klinicznych
Puerto Rico
- - San Juan, Puerto Rico, 00936
    - Latin Clinical Trial Center Inc. (LCTC)
Romania
- - Brasov, Romania, 500091
    - Centrul Medical Unirea SRL Brasov (Regina Maria)
  - Bucharest, Romania, 020125
    - Spitalul Clinic Colentina
  - Bucharest, Romania, 014146
    - Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
  - Cluj-Napoca, Romania, 400015
    - Angiocare S.R.L. (Spitalul Ares Cluj-Napoca)
  - Craiova, Romania, 200508
    - Spitalul Clinic Municipal Filantropia Craiova
  - Oradea, Romania, 410169
    - Spitalul Clinic Judetean de Urgenta Bihor
  - Timișoara, Romania, 300644
    - S.C Materna Care SRL Timisoara (Regina Maria)
  - Timișoara, Romania, 300723
    - Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
- Mureș County
  - Târgu Mureş, Mureș County, Romania, 540136
    - Spitalul Clinic Judetean de Urgenta Tg. Mures
- Timiș County
  - Timișoara, Timiș County, Romania, 300362
    - Centrul Medicali's Timisoara
Spain
- - Badajoz, Spain, 6080
    - Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
  - Barcelona, Spain, 8003
    - Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM)
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofia
  - Granada, Spain, 18014
    - Hospital Universitario Virgen de las Nieves (HUVN)
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28040
    - Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) - Instituto de Investigacion Sanitaria (IIS)
  - Santiago de Compostela, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
  - Valencia, Spain, 46010
    - Instituto de Investigacion Sanitaria (INCLIVA)
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
    - Aberdeen Royal Infirmary
  - Birmingham, United Kingdom, B9 5SS
    - University Hospitals Birmingham NHS Foundation Trust - Birmingham Regional Severe Asthma Service (BRSAS)
  - Canterbury, United Kingdom, CT1 3NG
    - East Kent Hospitals University NHS Foundation Trust
  - Carshalton, United Kingdom, SM5 1AA
    - Epsom and St Helier University Hospitals NHS Trust
  - Chippenham, United Kingdom, SN15 2SB
    - Rowden Surgery Rowden Medical Partnership
  - Glasgow, United Kingdom, G12 8TA
    - NHS Greater Glasgow and Clyde (NHSGGC)
  - Newquay, United Kingdom, TR7 1RU
    - Newquay Health Centre
  - Sheffield, United Kingdom, S5 7AU
    - Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
  - Stockton-on-Tees, United Kingdom, TS19 8PE
    - FutureMeds - Stockton-on-Tees
- Great Britain
  - Fowey, Great Britain, United Kingdom, PL23 1DT
    - Fowey River Practice - Fowey Surgery
  - London, Great Britain, United Kingdom, EC1M 6BQ
    - 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)
  - Plymouth, Great Britain, United Kingdom, PL5 3JB
    - Knowle House Surgery
  - Torpoint, Great Britain, United Kingdom, PL11 2TB
    - The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health
- Kent
  - Canterbury, Kent, United Kingdom, CT1 3NG
    - Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH)
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Advanced Cardiovascular, LLC - Alexander City Office
  - Birmingham, Alabama, United States, 35205
    - Central Research Associates, Inc
  - Birmingham, Alabama, United States, 35211-1309
    - Cardiology, P.C.
  - Birmingham, Alabama, United States, 35211
    - Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location
  - Foley, Alabama, United States, 36535
    - G & L Research LLC - Foley
  - Vestavia Hills, Alabama, United States, 35216
    - Accel Research Sites (ARS) - Birmingham Clinical Research Unit
- Arizona
  - Tucson, Arizona, United States, 85715
    - Del Sol Research
- California
  - Beverly Hills, California, United States, 90211
    - Entertainment Medical Group, Inc.
  - Granada Hills, California, United States, 91344
    - Amicis Research Center - Granada Hills
  - Granada Hills, California, United States, 91344
    - Amicis Research Center - Northridge
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research, LLC
  - Northridge, California, United States, 91324
    - Amicis Research Center
  - Pasadena, California, United States, 91101
    - Pasadena Clinical Trials
  - Pomona, California, United States, 91767
    - Empire Clinical Research (ECR)
  - Sacramento, California, United States, 95821
    - Clinical Trials Research (CTR) - Sacramento
  - San Dimas, California, United States, 91773
    - North America Research Institute
  - Valencia, California, United States, 91355
    - Amicis Research Center - Valencia
- Connecticut
  - Hamden, Connecticut, United States, 06517
    - CMR of Greater New Haven
  - Waterbury, Connecticut, United States, 06708-3346
    - Chase Medical Research, LLC - Hamden
- Florida
  - Hialeah, Florida, United States, 33012
    - Indago Research and Health Center
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville
  - Miami, Florida, United States, 33175
    - Nuovida Research Center Corp
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center
  - Orlando, Florida, United States, 32806
    - AES Orlando
  - Pembroke Pines, Florida, United States, 33026
    - Pines Care Research Center, LLC
  - Pembroke Pines, Florida, United States, 33026
    - Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
  - Port Orange, Florida, United States, 32127
    - Progressive Medical Research
  - Tampa, Florida, United States, 33606
    - Clinical Research of West Florida (CRWF) - Clearwater
  - The Villages, Florida, United States, 32162
    - AES The Villages
- Georgia
  - Atlanta, Georgia, United States, 30310-1458
    - Morehouse School of Medicine (MSM)
  - Columbus, Georgia, United States, 31904
    - ClinCept, LLC
  - Decatur, Georgia, United States, 30030
    - Accel Research Sites- Decatur
  - Lawrenceville, Georgia, United States, 30044
    - Georgia Clinical Research Center, Inc
- Idaho
  - Blackfoot, Idaho, United States, 83221
    - Elite Clinical Trials
  - Idaho Falls, Idaho, United States, 83404-7596
    - Rocky Mountain Diabetes Center
  - Meridian, Idaho, United States, 83616
    - Solaris Clinical Research (SCR)
- Illinois
  - Chicago, Illinois, United States, 60602
    - Synexus (Radiant Research, Inc) - Chicago
  - Flossmoor, Illinois, United States, 60422
    - Healthcare Research Network-Chicago, Illinois (Flossmoor) Location
  - Morton, Illinois, United States, 61550
    - Koch Family Medicine, S.C.
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine
- Indiana
  - Brownsburg, Indiana, United States, 46112
    - Investigators Research Group LLC
  - Indianapolis, Indiana, United States, 46237-6345
    - Franciscan Physician Network
  - Munster, Indiana, United States, 46321
    - ASHA Clinical Research- Munster, LLC
  - Newburgh, Indiana, United States, 47630
    - Synexus (Radiant Research, Inc) - Evansville
- Kentucky
  - Louisville, Kentucky, United States, 40213
    - Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
- Louisiana
  - New Orleans, Louisiana, United States, 70112-2600
    - Tulane Doctors - Heart & Vascular - Metairie
  - New Orleans, Louisiana, United States, 70119
    - The Alliance for Multispecialty Research LLC (AMR) - Louisiana
  - Shreveport, Louisiana, United States, 71101
    - Northwest Louisiana Nephrology, Llc - Shreveport
  - Shreveport, Louisiana, United States, 71115
    - Grace Research, LLC
- Massachusetts
  - Boston, Massachusetts, United States, 02131
    - Boston Clinical Trials (BCT)
  - Methuen, Massachusetts, United States, 01844
    - ActivMed Practices and Research
- Mississippi
  - Petal, Mississippi, United States, 39465
    - Hattiesburg Clinic - Medisync Clinical Research
- Missouri
  - Hazelwood, Missouri, United States, 63042
    - Healthcare Research Network-Hazelwood
  - Kansas City, Missouri, United States, 64111
    - Clinical Research Consultants (CRC) - Kansas City
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research Inc. (QCR) - Omaha
- Nevada
  - Henderson, Nevada, United States, 89052
    - Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD
  - Las Vegas, Nevada, United States, 89106
    - Sierra Clinical Research-Las Vegas
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center (Washoe Medical Center)
- New York
  - Jamaica, New York, United States, 11432
    - Synexus (Radiant Research, Inc) - New York
  - New Hyde Park, New York, United States, 11042-1214
    - North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park
  - New York, New York, United States, 10032-3725
    - Columbia University
- North Carolina
  - Asheboro, North Carolina, United States, 272205
    - Randolph Health Internal Medicine/ Triad Internal Medicine
  - Greenville, North Carolina, United States, 27834
    - Physicians East, P.A. - Endocrinology
  - Greenville, North Carolina, United States, 27834
    - East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
  - Morehead City, North Carolina, United States, 28557
    - Carteret Medical Group - Morehead City
  - New Bern, North Carolina, United States, 28562
    - Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC)
- Ohio
  - Canton, Ohio, United States, 44718
    - Diabetes & Endocrinology Associates of Stark County
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Lynn Institute of Norman (LION Research)
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18017
    - Valley Kidney Specialists PC - Allentown Cedar Crest
  - Pittsburgh, Pennsylvania, United States, 15236
    - Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location
  - Uniontown, Pennsylvania, United States, 15401
    - Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga Medical Research (CMR), LLC
  - Knoxville, Tennessee, United States, 37920
    - The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)
  - Memphis, Tennessee, United States, 38119
    - Clinical Neuroscience Solutions, Inc
- Texas
  - Carrollton, Texas, United States, 75006
    - Punzi Medical Center and Trinity Hypertension Research Institute
  - Dallas, Texas, United States, 75234
    - AES Dallas Fort Worth
  - Houston, Texas, United States, 77054
    - Juno Research, LLC
  - Houston, Texas, United States, 77036
    - Synergy Groups Medical
  - McAllen, Texas, United States, 78503
    - Discovery Clinical Trials (DCT) - McAllen
  - Missouri City, Texas, United States, 35010
    - Synergy Groups Medical - Missouri City
  - Plano, Texas, United States, 75093
    - North Texas Family Medicine (NTFM) - Plano Office
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute (SRI) - San Antonio
  - San Antonio, Texas, United States, 78258
    - Discovery Clinical Trials (DCT) - San Antonio
- Utah
  - Salt Lake City, Utah, United States, 84106
    - Global AES - Salt Lake City
  - West Jordan, Utah, United States, 84088
    - Velocity Clinical Research - Salt Lake City (Advanced Clinical Research)
- Virginia
  - Burke, Virginia, United States, 22015
    - Burke Internal Medicine
  - Norfolk, Virginia, United States, 23501
    - Eastern VA Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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

Exclusion Criteria:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Placebo once daily (QD) for 12 weeks	Drug: Placebo Placebo once daily (QD) for 12 weeks
Experimental: Dose 1 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks	Drug: lorundrostat Dose 1 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
Experimental: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: Week 6	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: Week 6		Week 6
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 Time Frame: Week 12		Week 12
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications Time Frame: 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	Week 6
Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications Time Frame: 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	Week 6
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 Time Frame: Week 6		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) Time Frame: Week 12		Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mineralys Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MLS-101-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...

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Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept.

Pulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)

United States
Abant Izzet Baysal University

Not yet recruiting

The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension (SAPH)

PRIMARY HYPERTENSION

Turkey (Türkiye)
SingHealth Polyclinics
Nanyang Polytechnic

Enrolling by invitation

Engaging Home-monitored Assessment to Navigate Clinical Decision-making (ENHANCe)

Hypertension,Essential

Singapore
Hacettepe University
Bozok University

Completed

Effects of Different Telerehabilitation Methods In Patients With Hypertension (TELE-HT) (TELE-HT)

Hypertension | Arterial Hypertension | Systemic Hypertension

Turkey (Türkiye)
BackBeat Medical Inc

Not yet recruiting

Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction

Hypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEF

Georgia
Xuanwu Hospital, Beijing

Not yet recruiting

High-Intensity Transcranial Alternating Current Stimulation (Hi-tACS) for Hypertension: A Randomized Controlled Trial

Primary Hypertension

China
Shenzhen Salubris Pharmaceuticals Co., Ltd.

Not yet recruiting

Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets

Primary Hypertension

China
Instituto de Cardiologia do Rio Grande do Sul

Completed

Chronic Effect of Isometric Exercise on Blood Pressure in Patients With Hypertension

Hypertension (HTN) | Hypertension Arterial

Brazil

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

Study Overview

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product manufactured in and exported from the U.S.

Clinical Trials on Hypertension

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