New pill shows promise for Long-Term blood pressure control

NCT ID NCT05968430

Disease control Sponsor: Mineralys Therapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 6 times

Summary

This study looks at the long-term safety and effectiveness of a drug called lorundrostat for people with high blood pressure. About 1,076 adults who have already taken lorundrostat in a previous study will continue taking it for up to 36 weeks. The goal is to see if the drug keeps blood pressure under control over time.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,076 people

The number who actually took part.

Started

Jul 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent signed by the participant, obtained before any study-related assessment is performed 2. At least 18 years of age at the time of signing the informed consent form (ICF) 3. 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 4. 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 5. Willing and able to comply with the study instructions and attend all scheduled study visits \[Randomized treatment withdrawal substudy only\] 6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant, or are breast-feeding 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol 3. In the opinion of the Investigator, any condition that will preclude participation in the study \[Randomized treatment withdrawal substudy only\] 4. 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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

Contacts and locations

Locations

ACRC Trials - Legacy Medical Village

Plano, Texas, 75093, United States
ACRC Trials - Legacy Medical Village Location

Plano, Texas, 75024, United States
AES - Dallas Fort Worth

Dallas, Texas, 75234, United States
AES - Orlando

Orlando, Florida, 32806, United States
AES Chicago/Synexus Clinical Research

Chicago, Illinois, 60602, United States
AES Evansville/Synexus Clinical Research

Evansville, Indiana, 47714, United States
AES New York/Synexus Clinical Research

New York, New York, 10027, United States
AES The Villages

The Villages, Florida, 32162, United States
AKDHC Medical Research Services, AZ

Phoenix, Arizona, 85016, United States
AMR - Knoxville

Knoxville, Tennessee, 37920, United States
AMS Cardiology (Elligo)

Horsham, Pennsylvania, 19044, United States
ASHA Clinical Research- Munster, LLC

Hammond, Indiana, 46324, United States
ASOMHIDC - Individual practice Cardio Tonus EOOD

Sofia, 1582, Bulgaria
Academic Medical Research Institute (AMRI) - Los Angeles

Los Angeles, California, 90022, United States
Accel Research Sites

Decatur, Georgia, 30030, United States
Accel Research Sites (ARS) - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States
Accelerated Enrollment Solutions (AES) - Anderson

Anderson, South Carolina, 29621, United States
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)

Vista, California, 92083, United States
ActiveMed Practices & Research LLC

Methuen, Massachusetts, 01844, United States
Albany Medical College

Albany, New York, 12203, United States
Alliance for Multispecialty Research, LLC

New Orleans, Louisiana, 70119, United States
Alta Pharmaceutical Research Center

Peachtree Corners, Georgia, 30092, United States
American Clinical Trials

Acworth, Georgia, 30101, United States
Amicis Research Center - Granada Hills

Granada Hills, California, 91344, United States
Amicis Research Center - Mission Hills

Northridge, California, 91324, United States
Amicis Research Center - Vacaville

Fairfield, California, 94533, United States
Amicis Research Center - Valencia

Valencia, California, 91355, United States
Amicis Research Center-Northridge

Northridge, California, 91324, United States
Amsterdam AMC

Amsterdam, 1105, Netherlands
Arizona Kidney

Glendale, Arizona, 85306, United States
Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research

Vandalia, Ohio, 45377, United States
AusTrials - Taringa

Taringa, QLD 4068, Australia
Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, 44124, Italy
Barts Health Nhs Trust

London, EC1M 6BQ, United Kingdom
Blue Coast Research Center (BCRC)

Vista, California, 92081, United States
Boston Clinical Trials

Boston, Massachusetts, 02131, United States
Burke Internal Medicine

Burke, Virginia, 22015, United States
CA Institute of Renal Research, CA

Chula Vista, California, 91910, United States
CMR of Greater New Haven

Hamden, Connecticut, 06512, United States
Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom
Carteret Medical Group

Morehead City, North Carolina, 28557, United States
Castle Hill Medical Centre

Castle Hill, NSW 2154, Australia
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centre Hospitalier Annecy Genevois - Site d'Annecy

Annecy, 74370, France
Centre Medical L'Acadie - Montreal

Montreal, Quebec, H4N 2W2, Canada
Centricity Research New Bern Multispecialty

New Bern, North Carolina, 28562, United States
Centrul Medical Unirea SRL Brasov (Regina Maria)

Brasov, 500091, Romania
Chandler Clinical Trials

Chandler, Arizona, 85224, United States
Chattanooga Medical Research

Chattanooga, Tennessee, 37412, United States
Cleveland Clinic - Main Campus

Cleveland, Ohio, 44195, United States
Clinical Investigations of Texas (CIT)

Plano, Texas, 75075, United States
Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States
Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States
Clinical Research Consultants (CRC) - Kansas City

Kansas City, Missouri, 64111, United States
Clinical Research of West Florida, Inc.

Tampa, Florida, 33606, United States
Clinical Trials Research (CTR) - Lincoln

Lincoln, California, 95648, United States
Clinical Trials Research (CTR) - Sacramento

Sacramento, California, 95821, United States
Clinmedica Research

Skierniewice, 96-100, Poland
Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States
Coastal Medical

Brunswick, Georgia, 31520, United States
Colorado Kidney (Denver) Nephrology

Denver, Colorado, 802320, United States
Columbia University

New York, New York, 10032, United States
Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)

Badajoz, 06070, Spain
DCC 1 - Veliko Tarnovo" EOOD

Veliko Tarnovo, 5000, Bulgaria
David Turbay, MD, PLLC (Elligo Health Research)

El Paso, Texas, 79905, United States
Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States
Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)

Bucharest, 014145, Romania
Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, 44240, United States
Discovery Clinical Trials

San Antonio, Texas, 78258, United States
ETG Warszawa

Warsaw, 02-644, Poland
Eagle Clinical Research

Chicago, Illinois, 60621, United States
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location

Greenville, North Carolina, 27834, United States
Eastern VA Medical School

Norfolk, Virginia, 23501, United States
Elite Clinical Trials

Blackfoot, Idaho, 83221, United States
Empire Clinical Research

Pomona, California, 91767, United States
Entertainment Medical Group, Inc

Beverly Hills, California, 90211, United States
Epsom and St Helier University Hospitals NHS Trust

Carshalton, SM5, United Kingdom
Erie County Medical Center

Buffalo, New York, 14215, United States
Etyka Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland
Fowey River Practice

Fowey, England, PL23 1DT, United Kingdom
FutureMeds GmbH

Berlin, 10629, Germany
Futuremeds Lodz

Lodz, 91-363, Poland
Futuremeds Olsztyn

Olsztyn, 10-010, Poland
G & L Research LLC

Foley, Alabama, 36535, United States
Gamma Medical Research, Inc

McAllen, Texas, 78503, United States
Georgia Clinical Research, LLC

Lawrenceville, Georgia, 30044, United States
Gulf Coast Clinical Research

Houston, Texas, 77070, United States
Hattiesburg Clinic

Petal, Mississippi, 39465, United States
Healthcare Research Network - Chicago

Flossmoor, Illinois, 60422, United States
Healthcare Research Network-Hazelwood

Hazelwood, Missouri, 63042, United States
Henderson Clinical Trials

Henderson, Nevada, 89052, United States
Hendricks Regional Health Medical Group - Lizton Family Medicine

Brownsburg, Indiana, 46112, United States
Herzzentrum Leipzig

Leipzig, 04289, Germany
Hospital Clínico Universitario Valencia

Valencia, 46010, Spain
Hospital Universitario Reina Sofia

Córdoba, 14005, Spain
Hospital Universitario Virgen de las Nieves

Granada, 18012, Spain
IRCCS AOU di Bologna - Policlinico S. Orsola

Bologna, 40138, Italy
IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy
Indago Research and Health Center

Hialeah, Florida, 33012, United States
Infigo Clinical Research (Mid Florida)

Sanford, Florida, 32771, United States
Intrepid Research

Cincinnati, Ohio, 45245, United States
Juno Research, LLC

Houston, Texas, 77054, United States
Kidney & Hypertension Center - Victorville

Victorville, California, 92395, United States
Klinische Forschung Dresden GmbH

Dresden, 01069, Germany
Knowle House Surgery

Plymouth, PL5 3JB, United Kingdom
Koch Family Medicine, S.C

Morton, Illinois, 61550, United States
Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States
Latin Clinical Trial Center

San Juan, 00909-1900, Puerto Rico
Lifedoc Research

Memphis, Tennessee, 38119, United States
Lynn Institute of Norman (LION Research)

Norman, Oklahoma, 73072, United States
MEDICALI'S SRL Timisoara

Timișoara, 300362, Romania
MVZ Jung GbR

Deggingen, 73326, Germany
Marvel Clinical Research 002, LLC

Huntington Beach, California, 92647, United States
Medical Center

Pleven, 5800, Bulgaria
Medical Center Hera EOOD - Sofia

Sofia, 1510, Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.

Gabrovo, 5300, Bulgaria
Medical Colleagues of Texas, LLP (Elligo Health Research)

Katy, Texas, 77450, United States
Meridian Family Medicine

Meridian, Idaho, 83646, United States
Morehouse School of Medicine

Atlanta, Georgia, 30310, United States
Nephrology Associates of Central Florida

Orlando, Florida, 32806-6257, United States
Nephrology Associates of Kentuckiana

Louisville, Kentucky, 40205, United States
Newquay Health Centre

Newquay, Cornwall, TR7 1RU, United Kingdom
Noble Clinical Research

Tucson, Arizona, 85704, United States
Northridge Clinical Trials

Northridge, California, 91325, United States
Northwest Louisiana Nephrology, LLC - Shreveport

Shreveport, Louisiana, 71101, United States
Nuovida Research Center Corp

Miami, Florida, 33186, United States
Oasis Clinical Trials

Las Vegas, Nevada, 89121, United States
Office of Audrey L. Jones, DO

McAllen, Texas, 78503, United States
Office of Ramon Mendez

Woodbridge, Virginia, 22192, United States
PRX Research - Mesquite

Mesquite, Texas, 75149, United States
Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)

West Palm Beach, Florida, 33401, United States
Pasadena Clinical Trials

Pasadena, California, 91101, United States
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)

Pembroke Pines, Florida, 33026, United States
Physician's East Endocrinology

Greenville, North Carolina, 27834, United States
Pines Care Research Center

Pembroke Pines, Florida, 33025, United States
Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States
Progressive Medical Research

Port Orange, Florida, 32127, United States
Punzi Medical Center

Carrollton, Texas, 75006, United States
Quality Clinical Research

Omaha, Nebraska, 68114, United States
Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom
Qway Research

Hialeah, Florida, 33010, United States
R & H Clinical Research

Katy, Texas, 77450, United States
Rame Medical Limited

Torpoint, PL11 2TB, United Kingdom
Renal Research - Gosford

Gosford, New South Wales, 2250, Australia
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Research Innovations (Elligo Health Research)

Beavercreek, Ohio, 45431, United States
Rowden Surgery Rowden Medical Partnership

Chippenham, Wilts, SN15 2SB, United Kingdom
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)

Katowice, 40-029, Poland
San Antonio ClinicalTrials

San Antonio, Texas, 78240, United States
San Jose Clinical Trials

San Jose, California, 95117, United States
Sierra Clinical Research

Las Vegas, Nevada, 89106, United States
Southern Illinois School of Medicine

Springfield, Illinois, 62702, United States
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara

Timișoara, 300723, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures

Târgu Mureş, 540136, Romania
Sugar Lakes Family Practice (Elligo Health Research)

Sugar Land, Texas, 77479, United States
Sun Research Institute (SRI) - San Antonio

San Antonio, Texas, 78215, United States
Synergy Groups Medical - Bissonet Site

Houston, Texas, 77036, United States
Synergy Groups Medical - Missouri City

Missouri City, Texas, 77459, United States
Synexus Clinical Research US, Inc.

Henderson, Nevada, 89052, United States
The Research Group of Lexington, LLC

Lexington, Kentucky, 40503, United States
The University of Chicago Medicine

Chicago, Illinois, 60637, United States
The University of Utah

Salt Lake City, Utah, 84132, United States
The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.

Perth, 6000, Australia
Triad Internal Medicine

Asheboro, North Carolina, 27205, United States
Triwest Research Associates

San Diego, California, 92108, United States
Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie

Leipzig, 04103, Germany
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California, 92037, United States
University of Messina

Messina, 98124, Italy
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Rome Sapienza, AO Sant'Andrea

Roma, 00189, Italy
University of Sunshine Coast Clinical Trial Centre

Sippy Downs, QLD 4556, Australia
Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, 37232, United States
Velocity Clinical Research

West Jordan, Utah, 84088, United States
Wake Research - Notus Clinical Trials, LLC

Charleston, South Carolina, 29414, United States
Willamette Valley Clinical Studies

Eugene, Oregon, 97404, United States

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