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
1 other identifier
interventional
1,076
13 countries
177
Brief Summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jul 2023
Longer than P75 for phase_3 hypertension
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2023
CompletedStudy Start
First participant enrolled
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 17, 2026
June 1, 2025
2.5 years
July 14, 2023
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from MLS-101-301 baseline automated office blood pressure
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
Week 36
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
Study Arms (3)
Open-Label Arm
EXPERIMENTALlorundrostat once daily for 52 weeks depending on when the subject enrolled
RTW Substudy
EXPERIMENTALlorundrostat 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
EXPERIMENTALlorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (177)
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216, United States
G & L Research LLC
Foley, Alabama, 36535, United States
Chandler Clinical Trials
Chandler, Arizona, 85224, United States
Arizona Kidney
Glendale, Arizona, 85306, United States
AKDHC Medical Research Services, AZ
Phoenix, Arizona, 85016, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Entertainment Medical Group, Inc
Beverly Hills, California, 90211, United States
CA Institute of Renal Research, CA
Chula Vista, California, 91910, United States
Amicis Research Center - Vacaville
Fairfield, California, 94533, United States
Amicis Research Center - Granada Hills
Granada Hills, California, 91344, United States
Marvel Clinical Research 002, LLC
Huntington Beach, California, 92647, United States
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037, United States
Clinical Trials Research (CTR) - Lincoln
Lincoln, California, 95648, United States
Academic Medical Research Institute (AMRI) - Los Angeles
Los Angeles, California, 90022, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Amicis Research Center - Mission Hills
Northridge, California, 91324, United States
Amicis Research Center-Northridge
Northridge, California, 91324, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
Pasadena Clinical Trials
Pasadena, California, 91101, United States
Empire Clinical Research
Pomona, California, 91767, United States
Clinical Trials Research (CTR) - Sacramento
Sacramento, California, 95821, United States
Triwest Research Associates
San Diego, California, 92108, United States
San Jose Clinical Trials
San Jose, California, 95117, United States
Amicis Research Center - Valencia
Valencia, California, 91355, United States
Kidney & Hypertension Center - Victorville
Victorville, California, 92395, United States
Blue Coast Research Center (BCRC)
Vista, California, 92081, United States
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
Vista, California, 92083, United States
Colorado Kidney (Denver) Nephrology
Denver, Colorado, 802320, United States
CMR of Greater New Haven
Hamden, Connecticut, 06512, United States
Qway Research
Hialeah, Florida, 33010, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Nuovida Research Center Corp
Miami, Florida, 33186, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Nephrology Associates of Central Florida
Orlando, Florida, 32806-6257, United States
AES - Orlando
Orlando, Florida, 32806, United States
Pines Care Research Center
Pembroke Pines, Florida, 33025, United States
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
Pembroke Pines, Florida, 33026, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Infigo Clinical Research (Mid Florida)
Sanford, Florida, 32771, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606, United States
AES The Villages
The Villages, Florida, 32162, United States
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)
West Palm Beach, Florida, 33401, United States
American Clinical Trials
Acworth, Georgia, 30101, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Coastal Medical
Brunswick, Georgia, 31520, United States
Accel Research Sites
Decatur, Georgia, 30030, United States
Georgia Clinical Research, LLC
Lawrenceville, Georgia, 30044, United States
Alta Pharmaceutical Research Center
Peachtree Corners, Georgia, 30092, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Meridian Family Medicine
Meridian, Idaho, 83646, United States
AES Chicago/Synexus Clinical Research
Chicago, Illinois, 60602, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
The University of Chicago Medicine
Chicago, Illinois, 60637, United States
Healthcare Research Network - Chicago
Flossmoor, Illinois, 60422, United States
Koch Family Medicine, S.C
Morton, Illinois, 61550, United States
Southern Illinois School of Medicine
Springfield, Illinois, 62702, United States
Hendricks Regional Health Medical Group - Lizton Family Medicine
Brownsburg, Indiana, 46112, United States
AES Evansville/Synexus Clinical Research
Evansville, Indiana, 47714, United States
ASHA Clinical Research- Munster, LLC
Hammond, Indiana, 46324, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503, United States
Nephrology Associates of Kentuckiana
Louisville, Kentucky, 40205, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana, 71101, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
ActiveMed Practices & Research LLC
Methuen, Massachusetts, 01844, United States
Hattiesburg Clinic
Petal, Mississippi, 39465, United States
Healthcare Research Network-Hazelwood
Hazelwood, Missouri, 63042, United States
Clinical Research Consultants (CRC) - Kansas City
Kansas City, Missouri, 64111, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Henderson Clinical Trials
Henderson, Nevada, 89052, United States
Synexus Clinical Research US, Inc.
Henderson, Nevada, 89052, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Oasis Clinical Trials
Las Vegas, Nevada, 89121, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Albany Medical College
Albany, New York, 12203, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
AES New York/Synexus Clinical Research
New York, New York, 10027, United States
Columbia University
New York, New York, 10032, United States
Triad Internal Medicine
Asheboro, North Carolina, 27205, United States
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
Greenville, North Carolina, 27834, United States
Physician's East Endocrinology
Greenville, North Carolina, 27834, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Centricity Research New Bern Multispecialty
New Bern, North Carolina, 28562, United States
Research Innovations (Elligo Health Research)
Beavercreek, Ohio, 45431, United States
Diabetes & Endocrinology Associates of Stark County
Canton, Ohio, 44240, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195, United States
Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
Vandalia, Ohio, 45377, United States
Lynn Institute of Norman (LION Research)
Norman, Oklahoma, 73072, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
AMS Cardiology (Elligo)
Horsham, Pennsylvania, 19044, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Accelerated Enrollment Solutions (AES) - Anderson
Anderson, South Carolina, 29621, United States
Wake Research - Notus Clinical Trials, LLC
Charleston, South Carolina, 29414, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37412, United States
AMR - Knoxville
Knoxville, Tennessee, 37920, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119, United States
Lifedoc Research
Memphis, Tennessee, 38119, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232, United States
Punzi Medical Center
Carrollton, Texas, 75006, United States
AES - Dallas Fort Worth
Dallas, Texas, 75234, United States
David Turbay, MD, PLLC (Elligo Health Research)
El Paso, Texas, 79905, United States
Synergy Groups Medical - Bissonet Site
Houston, Texas, 77036, United States
Juno Research, LLC
Houston, Texas, 77054, United States
Gulf Coast Clinical Research
Houston, Texas, 77070, United States
Medical Colleagues of Texas, LLP (Elligo Health Research)
Katy, Texas, 77450, United States
R & H Clinical Research
Katy, Texas, 77450, United States
Gamma Medical Research, Inc
McAllen, Texas, 78503, United States
Office of Audrey L. Jones, DO
McAllen, Texas, 78503, United States
PRX Research - Mesquite
Mesquite, Texas, 75149, United States
Synergy Groups Medical - Missouri City
Missouri City, Texas, 77459, United States
ACRC Trials - Legacy Medical Village Location
Plano, Texas, 75024, United States
Clinical Investigations of Texas (CIT)
Plano, Texas, 75075, United States
ACRC Trials - Legacy Medical Village
Plano, Texas, 75093, United States
Sun Research Institute (SRI) - San Antonio
San Antonio, Texas, 78215, United States
San Antonio ClinicalTrials
San Antonio, Texas, 78240, United States
Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Sugar Lakes Family Practice (Elligo Health Research)
Sugar Land, Texas, 77479, United States
The University of Utah
Salt Lake City, Utah, 84132, United States
Velocity Clinical Research
West Jordan, Utah, 84088, United States
Burke Internal Medicine
Burke, Virginia, 22015, United States
Eastern VA Medical School
Norfolk, Virginia, 23501, United States
Office of Ramon Mendez
Woodbridge, Virginia, 22192, United States
Renal Research - Gosford
Gosford, New South Wales, 2250, Australia
Castle Hill Medical Centre
Castle Hill, NSW 2154, Australia
The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.
Perth, 6000, Australia
University of Sunshine Coast Clinical Trial Centre
Sippy Downs, QLD 4556, Australia
AusTrials - Taringa
Taringa, QLD 4068, Australia
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo, 5300, Bulgaria
Medical Center
Pleven, 5800, Bulgaria
Medical Center Hera EOOD - Sofia
Sofia, 1510, Bulgaria
ASOMHIDC - Individual practice Cardio Tonus EOOD
Sofia, 1582, Bulgaria
DCC 1 - Veliko Tarnovo" EOOD
Veliko Tarnovo, 5000, Bulgaria
Centre Medical L'Acadie - Montreal
Montreal, Quebec, H4N 2W2, Canada
Centre Hospitalier Annecy Genevois - Site d'Annecy
Annecy, 74370, France
FutureMeds GmbH
Berlin, 10629, Germany
MVZ Jung GbR
Deggingen, 73326, Germany
Klinische Forschung Dresden GmbH
Dresden, 01069, Germany
Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie
Leipzig, 04103, Germany
Herzzentrum Leipzig
Leipzig, 04289, Germany
IRCCS AOU di Bologna - Policlinico S. Orsola
Bologna, 40138, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara, 44124, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
University of Messina
Messina, 98124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
University of Rome Sapienza, AO Sant'Andrea
Roma, 00189, Italy
Amsterdam AMC
Amsterdam, 1105, Netherlands
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)
Katowice, 40-029, Poland
Futuremeds Lodz
Lodz, 91-363, Poland
Futuremeds Olsztyn
Olsztyn, 10-010, Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
Clinmedica Research
Skierniewice, 96-100, Poland
ETG Warszawa
Warsaw, 02-644, Poland
Latin Clinical Trial Center
San Juan, 00909-1900, Puerto Rico
Centrul Medical Unirea SRL Brasov (Regina Maria)
Brasov, 500091, Romania
Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
Bucharest, 014145, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, 540136, Romania
MEDICALI'S SRL Timisoara
Timișoara, 300362, Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
Timișoara, 300723, Romania
Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
Badajoz, 06070, Spain
Hospital Universitario Reina Sofia
Córdoba, 14005, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18012, Spain
Hospital Clínico Universitario Valencia
Valencia, 46010, Spain
Newquay Health Centre
Newquay, Cornwall, TR7 1RU, United Kingdom
Fowey River Practice
Fowey, England, PL23 1DT, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF, United Kingdom
Rowden Surgery Rowden Medical Partnership
Chippenham, Wilts, SN15 2SB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
Carshalton, SM5, United Kingdom
Barts Health Nhs Trust
London, EC1M 6BQ, United Kingdom
Knowle House Surgery
Plymouth, PL5 3JB, United Kingdom
Rame Medical Limited
Torpoint, PL11 2TB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Eligible subjects participating in the RTW will receive double-blind treatment with matching placebo. Upon completion, subjects will return to open-label treatment
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2023
First Posted
August 1, 2023
Study Start
July 14, 2023
Primary Completion
December 30, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
February 17, 2026
Record last verified: 2025-06