Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
- Registration Number
- NCT05968430
- Lead Sponsor
- Mineralys Therapeutics Inc.
- Brief Summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
- Detailed Description
The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension.
This study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.
A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.
Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1400
-
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
-
Women who are pregnant, plan to become pregnant, or are breast-feeding
-
Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
-
In the opinion of the Investigator, any condition that will preclude participation in the study
[Randomized treatment withdrawal substudy only]
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-Label Arm lorundrostat lorundrostat once daily for 52 weeks depending on when the subject enrolled RTW Substudy lorundrostat lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only RTW Substudy Placebo lorundrostat or placebo once daily for 4 weeks starting at week 12, in the double-blind randomized treatment withdrawal substudy Optional for subjects from the MLS-101-301 parent study only Optional Continuation Period lorundrostat lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor
- Primary Outcome Measures
Name Time Method Change from MLS-101-301 baseline automated office blood pressure Week 36 Change from MLS-101-301 baseline automated office blood pressure (AOBP) systolic blood pressure (SBP) at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy
Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW Week 16
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (172)
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Nephrology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Nuovida Research Center Corp
🇺🇸Miami, Florida, United States
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
G & L Research LLC
🇺🇸Foley, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Arizona Kidney
🇺🇸Glendale, Arizona, United States
AKDHC Medical Research Services, AZ
🇺🇸Phoenix, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Entertainment Medical Group, Inc
🇺🇸Beverly Hills, California, United States
CA Institute of Renal Research, CA
🇺🇸Chula Vista, California, United States
Amicis Research Center - Vacaville
🇺🇸Fairfield, California, United States
Amicis Research Center - Granada Hills
🇺🇸Granada Hills, California, United States
Marvel Clinical Research 002, LLC
🇺🇸Huntington Beach, California, United States
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
🇺🇸La Jolla, California, United States
Clinical Trials Research (CTR) - Lincoln
🇺🇸Lincoln, California, United States
Academic Medical Research Institute (AMRI) - Los Angeles
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Amicis Research Center - Mission Hills
🇺🇸Northridge, California, United States
Amicis Research Center-Northridge
🇺🇸Northridge, California, United States
Northridge Clinical Trials
🇺🇸Northridge, California, United States
Pasadena Clinical Trials
🇺🇸Pasadena, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Clinical Trials Research (CTR) - Sacramento
🇺🇸Sacramento, California, United States
Triwest Research Associates
🇺🇸San Diego, California, United States
San Jose Clinical Trials
🇺🇸San Jose, California, United States
Amicis Research Center - Valencia
🇺🇸Valencia, California, United States
Kidney & Hypertension Center - Victorville
🇺🇸Victorville, California, United States
Blue Coast Research Center (BCRC)
🇺🇸Vista, California, United States
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
🇺🇸Vista, California, United States
Colorado Kidney (Denver) Nephrology
🇺🇸Denver, Colorado, United States
CMR of Greater New Haven
🇺🇸Hamden, Connecticut, United States
Qway Research
🇺🇸Hialeah, Florida, United States
AusTrials - Taringa
🇦🇺Taringa, Australia
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
AES - Orlando
🇺🇸Orlando, Florida, United States
Pines Care Research Center
🇺🇸Pembroke Pines, Florida, United States
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
🇺🇸Pembroke Pines, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Infigo Clinical Research (Mid Florida)
🇺🇸Sanford, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
AES The Villages
🇺🇸The Villages, Florida, United States
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)
🇺🇸West Palm Beach, Florida, United States
American Clinical Trials
🇺🇸Acworth, Georgia, United States
Morehouse School of Medicine
🇺🇸Atlanta, Georgia, United States
Coastal Medical
🇺🇸Brunswick, Georgia, United States
Accel Research Sites
🇺🇸Decatur, Georgia, United States
Georgia Clinical Research, LLC
🇺🇸Lawrenceville, Georgia, United States
Alta Pharmaceutical Research Center
🇺🇸Peachtree Corners, Georgia, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Meridian Family Medicine
🇺🇸Meridian, Idaho, United States
AES Chicago/Synexus Clinical Research
🇺🇸Chicago, Illinois, United States
Eagle Clinical Research
🇺🇸Chicago, Illinois, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Healthcare Research Network - Chicago
🇺🇸Flossmoor, Illinois, United States
Koch Family Medicine, S.C
🇺🇸Morton, Illinois, United States
Southern Illinois School of Medicine
🇺🇸Springfield, Illinois, United States
Hendricks Regional Health Medical Group - Lizton Family Medicine
🇺🇸Brownsburg, Indiana, United States
AES Evansville/Synexus Clinical Research
🇺🇸Evansville, Indiana, United States
ASHA Clinical Research- Munster, LLC
🇺🇸Hammond, Indiana, United States
The Research Group of Lexington, LLC
🇺🇸Lexington, Kentucky, United States
Nephrology Associates of Kentuckiana
🇺🇸Louisville, Kentucky, United States
Alliance for Multispecialty Research, LLC
🇺🇸New Orleans, Louisiana, United States
Northwest Louisiana Nephrology, LLC - Shreveport
🇺🇸Shreveport, Louisiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
ActiveMed Practices & Research LLC
🇺🇸Methuen, Massachusetts, United States
Hattiesburg Clinic
🇺🇸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
🇺🇸Omaha, Nebraska, United States
AES - Nevada
🇺🇸Henderson, Nevada, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Oasis Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Albany Medical College
🇺🇸Albany, New York, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
AES New York/Synexus Clinical Research
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
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
Physician's East Endocrinology
🇺🇸Greenville, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Lucas Research
🇺🇸New Bern, North Carolina, United States
Research Innovations (Elligo Health Research)
🇺🇸Beavercreek, Ohio, United States
Diabetes & Endocrinology Associates of Stark County
🇺🇸Canton, Ohio, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic - Main Campus
🇺🇸Cleveland, Ohio, United States
Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
🇺🇸Vandalia, Ohio, United States
Lynn Institute of Norman (LION Research)
🇺🇸Norman, Oklahoma, United States
Willamette Valley Clinical Studies
🇺🇸Eugene, Oregon, United States
AMS Cardiology (Elligo)
🇺🇸Horsham, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Accelerated Enrollment Solutions (AES) - Anderson
🇺🇸Anderson, South Carolina, United States
Wake Research - Notus Clinical Trials, LLC
🇺🇸Charleston, South Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Chattanooga Medical Research
🇺🇸Chattanooga, Tennessee, United States
AMR - Knoxville
🇺🇸Knoxville, Tennessee, United States
Lifedoc Research
🇺🇸Memphis, Tennessee, United States
Vanderbilt University Medical Center (VUMC)
🇺🇸Nashville, Tennessee, United States
Punzi Medical Center
🇺🇸Carrollton, Texas, United States
AES - Dallas Fort Worth
🇺🇸Dallas, Texas, United States
Medical Center New Polyclinic Gabrovo Ltd.
🇧🇬Gabrovo, Bulgaria
David Turbay, MD, PLLC (Elligo Health Research)
🇺🇸El Paso, Texas, United States
Synergy Groups Medical - Bissonet Site
🇺🇸Houston, Texas, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States
Gulf Coast Clinical Research
🇺🇸Houston, Texas, United States
Medical Colleagues of Texas, LLP (Elligo Health Research)
🇺🇸Katy, Texas, United States
R & H Clinical Research
🇺🇸Katy, Texas, United States
Gamma Medical Research, Inc
🇺🇸McAllen, Texas, United States
Office of Audrey L. Jones, DO
🇺🇸McAllen, Texas, United States
PRX Research - Mesquite
🇺🇸Mesquite, Texas, United States
Synergy Groups Medical - Missouri City
🇺🇸Missouri City, Texas, United States
ACRC Trials - Legacy Medical Village Location
🇺🇸Plano, Texas, United States
Clinical Investigations of Texas (CIT)
🇺🇸Plano, Texas, United States
ACRC Trials - Legacy Medical Village
🇺🇸Plano, Texas, United States
Sun Research Institute (SRI) - San Antonio
🇺🇸San Antonio, Texas, United States
San Antonio ClinicalTrials
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice (Elligo Health Research)
🇺🇸Sugar Land, Texas, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Burke Internal Medicine
🇺🇸Burke, Virginia, United States
Eastern VA Medical School
🇺🇸Norfolk, Virginia, United States
Office of Ramon Mendez
🇺🇸Woodbridge, Virginia, United States
Renal Research - Gosford
🇦🇺Gosford, New South Wales, Australia
Castle Hill Medical Centre
🇦🇺Castle Hill, Australia
The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.
🇦🇺Perth, Australia
University of Sunshine Coast Clinical Trial Centre
🇦🇺Sippy Downs, Australia
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Medical Center
🇧🇬Pleven, Bulgaria
ASOMHIDC - Individual practice Cardio Tonus EOOD
🇧🇬Sofia, Bulgaria
DCC 1 - Veliko Tarnovo" EOOD
🇧🇬Veliko Tarnovo, Bulgaria
Centre Medical L'Acadie - Montreal
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier Annecy Genevois - Site d'Annecy
🇫🇷Annecy, France
Emovis GmbH
🇩🇪Berlin, Germany
MVZ Jung GbR
🇩🇪Deggingen, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie
🇩🇪Leipzig, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
IRCCS AOU di Bologna - Policlinico S. Orsola
🇮🇹Bologna, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
University of Messina
🇮🇹Messina, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
University of Rome Sapienza, AO Sant'Andrea
🇮🇹Roma, Italy
Amsterdam AMC
🇳🇱Amsterdam, Netherlands
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)
🇵🇱Katowice, Poland
Futuremeds Lodz
🇵🇱Lodz, Poland
Futuremeds Olsztyn
🇵🇱Olsztyn, Poland
Etyka Osrodek Badan Klinicznych
🇵🇱Olsztyn, Poland
Clinmedica Research
🇵🇱Skierniewice, Poland
ETG Warszawa
🇵🇱Warsaw, Poland
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Centrul Medical Unirea SRL Brasov (Regina Maria)
🇷🇴Brasov, Romania
Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
🇷🇴București, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
🇷🇴Targu Mures, Romania
MEDICALI'S SRL Timisoara
🇷🇴Timisoara, Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
🇷🇴Timisoara, Romania
Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
🇪🇸Badajoz, Spain
Hospital Clínico Universitario Valencia
🇪🇸Valencia, Spain
Newquay Health Centre
🇬🇧Newquay, Cornwall, United Kingdom
Fowey River Practice
🇬🇧Fowey, England, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Rowden Surgery Rowden Medical Partnership
🇬🇧Chippenham, Wilts, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
🇬🇧Carshalton, United Kingdom
Barts Health Nhs Trust
🇬🇧London, United Kingdom
Knowle House Surgery
🇬🇧Plymouth, United Kingdom
Rame Medical Limited
🇬🇧Torpoint, United Kingdom