NCT05968430Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1076 (actual)
- First submitted
- 14 Jul 2023
- Start date
- 14 Jul 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Mineralys Therapeutics Inc.
- Diseases
- High blood pressure
- NCT number
- NCT05968430
- EU CT number
- 2023-506425-12-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1076
- From 14 Jul 2023 to the primary completion date, 30 Dec 2025
- 217 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
- Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901
Other illness
- In the opinion of the Investigator, any condition that will preclude participation in the study
- \[Randomized treatment withdrawal substudy only\]
Other
- Women who are pregnant, plan to become pregnant, or are breast-feeding
Who the study is looking for
- Written informed consent signed by the participant, obtained before any study-related assessment is performed
- At least 18 years of age at the time of signing the informed consent form (ICF)
- Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
- Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
- Willing and able to comply with the study instructions and attend all scheduled study visits
- \[Randomized treatment withdrawal substudy only\]
- Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (217)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Castle Hill Medical Centre Coordinator of this site? Confirm its status | Castle Hill | Australia | Unknown status |
| Renal Research Gosford Coordinator of this site? Confirm its status | Gosford | Australia | Unknown status |
| The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit. Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| University of Sunshine Coast Clinical Trial Centre Coordinator of this site? Confirm its status | Sippy Downs | Australia | Unknown status |
| AusTrials - Taringa Coordinator of this site? Confirm its status | Taringa | Australia | Unknown status |
| Medical Center New Polyclinic Gabrovo Ltd. Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Completed |
| Medical Center Exacta Medica OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Completed |
| ASOMHIDC - Individual practice "Cardio Tonus" EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center Medicabilis Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Medical Center Zara-Med EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Completed |
| Diagnostic And Consulting Center 1 Veliko Tarnovo Ltd. Coordinator of this site? Confirm its status | Veliko Tirnovo | Bulgaria | Completed |
| Centre Medical L'Acadie - Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Emovis GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Medizinisches Versorgungszentrum Jung GbR Coordinator of this site? Confirm its status | Deggingen | Germany | Completed |
| Klinische Forschung Dresden GmbH Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Klinische Forschung Hannover-Mitte GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Klinische Forschung Karlsruhe GmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Completed |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Herzzentrum Leipzig GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| PSHI Praxis GmbH Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Kidney Center Wiesbaden-Rheumatology Coordinator of this site? Confirm its status | Wiesbaden | Germany | Completed |
| Servicio Extremeño de Salud - COMPLEJO HOSPITALARIO UNIVERSITARIO DE BADAJOZ (CHUB) Coordinator of this site? Confirm its status | Badajoz | Spain | Completed |
| Consorci Mar Parc De Salut De Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Area Sanitaria De Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Completed |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Universidade De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago De Compostela | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Completed |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Completed |
| Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Epsom and St Helier University Hospitals NHS Trust Coordinator of this site? Confirm its status | Carshalton | United Kingdom | Unknown status |
| Rowden Surgery Rowden Medical Partnership Coordinator of this site? Confirm its status | Chippenham | United Kingdom | Unknown status |
| Fowey River Practice Coordinator of this site? Confirm its status | Fowey | United Kingdom | Unknown status |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newquay Health Centre Coordinator of this site? Confirm its status | Newquay | United Kingdom | Unknown status |
| Knowle House Surgery Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Rame Medical Limited Coordinator of this site? Confirm its status | Torpoint | United Kingdom | Unknown status |
| I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli Anziani Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Completed |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina Coordinator of this site? Confirm its status | Messina | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Università degli Studi di Modena e Reggio Emilia Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| Azienda Sanitaria Universitaria Friuli Centrale Coordinator of this site? Confirm its status | Udine | Italy | Completed |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Completed |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Utrecht University Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Diamond Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Silmedic Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| FutureMeds Sp. z o.o. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Velocity Skierniewice Sp. z o.o. Coordinator of this site? Confirm its status | Skierniewice | Poland | Completed |
| ETG Neuroscience Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Latin Clinical Trial Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Centrul Medical Unirea S.R.L. Coordinator of this site? Confirm its status | Brasov | Romania | Completed |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Angiocare S.R.L. Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Spitalul Clinic Municipal Filantropia Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Bihor Coordinator of this site? Confirm its status | Oradea | Romania | Completed |
| Spitalul Clinic Judetean de Urgenta Targu Mures Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| Materna Care S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| Medicali's S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| American Clinical Trials Coordinator of this site? Confirm its status | Acworth | United States | Unknown status |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Accelerated Enrollment Solutions (AES) - Anderson Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Triad Internal Medicine Coordinator of this site? Confirm its status | Asheboro | United States | Unknown status |
| Morehouse School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Research Innovations (Elligo Health Research) Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| Entertainment Medical Group, Inc Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Accel Research Sites (ARS) - Birmingham Clinical Research Unit Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Elite Clinical Trials Coordinator of this site? Confirm its status | Blackfoot | United States | Unknown status |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Hendricks Regional Health Medical Group - Lizton Family Medicine Coordinator of this site? Confirm its status | Brownsburg | United States | Unknown status |
| Coastal Medical Coordinator of this site? Confirm its status | Brunswick | United States | Unknown status |
| Erie County Medical Center Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Burke Internal Medicine Coordinator of this site? Confirm its status | Burke | United States | Unknown status |
| Diabetes & Endocrinology Associates of Stark County Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Punzi Medical Center Coordinator of this site? Confirm its status | Carrollton | United States | Unknown status |
| Chandler Clinical Trials Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Wake Research - Notus Clinical Trials, LLC Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Chattanooga Medical Research Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| AES Chicago/Synexus Clinical Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Eagle Clinical Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The University of Chicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| CA Institute of Renal Research, CA Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| Intrepid Research Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| AES - Dallas Fort Worth Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Colorado Kidney (Denver) Nephrology Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| David Turbay, MD, PLLC (Elligo Health Research) Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Willamette Valley Clinical Studies Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| AES Evansville/Synexus Clinical Research Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| Amicis Research Center - Vacaville Coordinator of this site? Confirm its status | Fairfield | United States | Unknown status |
| Healthcare Research Network - Chicago Coordinator of this site? Confirm its status | Flossmoor | United States | Unknown status |
| G & L Research LLC Coordinator of this site? Confirm its status | Foley | United States | Unknown status |
| Arizona Kidney Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Amicis Research Center - Granada Hills Coordinator of this site? Confirm its status | Granada Hills | United States | Unknown status |
| East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Physician's East Endocrinology Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| CMR of Greater New Haven Coordinator of this site? Confirm its status | Hamden | United States | Unknown status |
| ASHA Clinical Research-Munster, LLC Coordinator of this site? Confirm its status | Hammond | United States | Unknown status |
| Healthcare Research Network-Hazelwood Coordinator of this site? Confirm its status | Hazelwood | United States | Unknown status |
| Synexus Clinical Research US, Inc. Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Henderson Clinical Trials Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Indago Research and Health Center Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Qway Research Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| AMS Cardiology (Elligo) Coordinator of this site? Confirm its status | Horsham | United States | Unknown status |
| Juno Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Gulf Coast Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Synergy Groups Medical - Bissonet Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Marvel Clinical Research 002, LLC Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Clinical NeuroScience Solutions Inc Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Clinical Research Consultants (CRC) - Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Medical Colleagues of Texas, LLP (Elligo Health Research) Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| R & H Clinical Research Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| AMR Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Sierra Clinical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Oasis Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Georgia Clinical Research, LLC Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| The Research Group of Lexington LLC Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Clinical Trials Research (CTR) - Lincoln Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Academic Medical Research Institute (AMRI) - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Nephrology Associates of Kentuckiana Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Gamma Medical Research, Inc. Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Office of Audrey L. Jones, DO Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Lifedoc Research Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
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| PRX Research - Mesquite Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
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| Coastal Carolina Research Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Las Vegas Clinical Trials Coordinator of this site? Confirm its status | North Las Vegas | United States | Unknown status |
| Amicis Research Center - Mission Hills Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Amicis Research Center-Northridge Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Northridge Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Quality Clinical Research Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Nephrology Associates of Central Florida Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AES - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Pasadena Clinical Trials Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
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