Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension

Last updated: May 5, 2025
Sponsor: Mineralys Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Williams Syndrome

Circulation Disorders

Vascular Diseases

Treatment

lorundrostat

Placebo

Clinical Study ID

NCT05968430
MLS-101-901
  • Ages > 18
  • All Genders

Study Summary

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent signed by the participant, obtained before anystudy-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 theoption of transitioning to the OLE study, in accordance with the parent studyprotocol

  4. Fertile male subjects and female subjects of childbearing potential, and theirpartners, must agree to use an acceptable method of contraception from study entryto 28 days after the last dose of study drug

  5. Willing and able to comply with the study instructions and attend all scheduledstudy visits

[Randomized treatment withdrawal substudy only]

  1. Written informed consent to participate in the RTW substudy signed by theparticipant, obtained before any RTW study-related assessment is performed

Exclusion

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 medicationas listed in Section 6.7.1 of the protocol

  3. In the opinion of the Investigator, any condition that will preclude participationin the study

[Randomized treatment withdrawal substudy only]

  1. Non-compliance with study medication(s) (defined as taking <75% or >125% of thestudy drug provided) during the first 12 weeks of MLS-101-901

Study Design

Total Participants: 1400
Treatment Group(s): 2
Primary Treatment: lorundrostat
Phase: 3
Study Start date:
July 14, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Renal Research - Gosford

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Castle Hill Medical Centre

    Castle Hill, NSW 2154
    Australia

    Site Not Available

  • The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.

    Perth, 6000
    Australia

    Site Not Available

  • University of Sunshine Coast Clinical Trial Centre

    Sippy Downs, QLD 4556
    Australia

    Site Not Available

  • AusTrials - Taringa

    Taringa, QLD 4068
    Australia

    Site Not Available

  • Medical Center New Polyclinic Gabrovo Ltd.

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • Medical Center

    Pleven, 5800
    Bulgaria

    Site Not Available

  • ASOMHIDC - Individual practice Cardio Tonus EOOD

    Sofia, 1582
    Bulgaria

    Site Not Available

  • DCC 1 - Veliko Tarnovo" EOOD

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Centre Medical L'Acadie - Montreal

    Montréal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Annecy, 74370
    France

    Site Not Available

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Epagny Metz Tessy, 74370
    France

    Site Not Available

  • Emovis GmbH

    Berlin, 10629
    Germany

    Site Not Available

  • MVZ Jung GbR

    Deggingen, 73326
    Germany

    Site Not Available

  • Klinische Forschung Dresden GmbH

    Dresden, 01069
    Germany

    Site Not Available

  • Herzzentrum Leipzig

    Leipzig, 04289
    Germany

    Site Not Available

  • Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie

    Leipzig, 04103
    Germany

    Site Not Available

  • IRCCS AOU di Bologna - Policlinico S. Orsola

    Bologna, 40138
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

  • University of Messina

    Messina, 98124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Site Not Available

  • University of Rome Sapienza, AO Sant'Andrea

    Roma, 00189
    Italy

    Site Not Available

  • Amsterdam AMC

    Amsterdam, 1105
    Netherlands

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)

    Katowice, 40-029
    Poland

    Site Not Available

  • Futuremeds Lodz

    Lodz, 91-363
    Poland

    Site Not Available

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10-117
    Poland

    Site Not Available

  • Futuremeds Olsztyn

    Olsztyn, 10-010
    Poland

    Site Not Available

  • Clinmedica Research

    Skierniewice, 96-100
    Poland

    Site Not Available

  • ETG Warszawa

    Warsaw, 02-644
    Poland

    Site Not Available

  • ETG Warszawa

    Warzawa, 02-644
    Poland

    Site Not Available

  • Latin Clinical Trial Center

    San Juan, 00909-1900
    Puerto Rico

    Site Not Available

  • Centrul Medical Unirea SRL Brasov (Regina Maria)

    Brasov, 500091
    Romania

    Site Not Available

  • Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)

    București, 014145
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Targu Mures, 540136
    Romania

    Site Not Available

  • MEDICALI'S SRL Timisoara

    Timisoara, 300362
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara

    Timisoara, 300723
    Romania

    Site Not Available

  • Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)

    Badajoz, 06070
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14005
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18012
    Spain

    Site Not Available

  • Hospital Clínico Universitario Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Newquay Health Centre

    Newquay, Cornwall TR7 1RU
    United Kingdom

    Site Not Available

  • Fowey River Practice

    Fowey, England PL23 1DT
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Scotland G51 4TF
    United Kingdom

    Site Not Available

  • Rowden Surgery Rowden Medical Partnership

    Chippenham, Wilts SN15 2SB
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Epsom and St Helier University Hospitals NHS Trust

    Carshalton, SM5
    United Kingdom

    Site Not Available

  • Barts Health Nhs Trust

    London, EC1M 6BQ
    United Kingdom

    Site Not Available

  • Knowle House Surgery

    Plymouth, PL5 3JB
    United Kingdom

    Site Not Available

  • Rame Medical Limited

    Torpoint, PL11 2TB
    United Kingdom

    Site Not Available

  • Accel Research Sites (ARS) - Birmingham Clinical Research Unit

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • G & L Research LLC

    Foley, Alabama 36535
    United States

    Site Not Available

  • G &amp; L Research LLC

    Foley, Alabama 36535
    United States

    Site Not Available

  • Chandler Clinical Trials

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Arizona Kidney

    Glendale, Arizona 85306
    United States

    Site Not Available

  • AKDHC Medical Research Services, AZ

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Entertainment Medical Group, Inc

    Beverly Hills, California 90211
    United States

    Site Not Available

  • CA Institute of Renal Research, CA

    Chula Vista, California 91910
    United States

    Site Not Available

  • Amicis Research Center - Vacaville

    Fairfield, California 94533
    United States

    Site Not Available

  • Amicis Research Center - Granada Hills

    Granada Hills, California 91344
    United States

    Site Not Available

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California 92647
    United States

    Site Not Available

  • University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)

    La Jolla, California 92037
    United States

    Site Not Available

  • Clinical Trials Research (CTR) - Lincoln

    Lincoln, California 95648
    United States

    Site Not Available

  • Academic Medical Research Institute (AMRI) - Los Angeles

    Los Angeles, California 90022
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Amicis Research Center - Mission Hills

    Northridge, California 91324
    United States

    Site Not Available

  • Amicis Research Center-Northridge

    Northridge, California 91324
    United States

    Site Not Available

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Site Not Available

  • Pasadena Clinical Trials

    Pasadena, California 91101
    United States

    Site Not Available

  • Empire Clinical Research

    Pomona, California 91767
    United States

    Site Not Available

  • Clinical Trials Research (CTR) - Sacramento

    Sacramento, California 95821
    United States

    Site Not Available

  • Triwest Research Associates

    San Diego, California 92108
    United States

    Site Not Available

  • San Jose Clinical Trials

    San Jose, California 95117
    United States

    Site Not Available

  • Amicis Research Center - Valencia

    Valencia, California 91355
    United States

    Site Not Available

  • Kidney & Hypertension Center - Victorville

    Victorville, California 92395
    United States

    Site Not Available

  • Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)

    Vista, California 92083
    United States

    Site Not Available

  • Blue Coast Research Center (BCRC)

    Vista, California 92081
    United States

    Site Not Available

  • Colorado Kidney (Denver) Nephrology

    Denver, Colorado 802320
    United States

    Site Not Available

  • CMR of Greater New Haven

    Hamden, Connecticut 06512
    United States

    Site Not Available

  • Indago Research and Health Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Qway Research

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Nuovida Research Center Corp

    Miami, Florida 33186
    United States

    Site Not Available

  • AES - Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida 32801
    United States

    Site Not Available

  • Nephrology Associates of Central Florida

    Orlando, Florida 32806-6257
    United States

    Site Not Available

  • Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • Pines Care Research Center

    Pembroke Pines, Florida 33025
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Infigo Clinical Research (Mid Florida)

    Sanford, Florida 32771
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33606
    United States

    Site Not Available

  • AES The Villages

    The Villages, Florida 32162
    United States

    Site Not Available

  • Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • American Clinical Trials

    Acworth, Georgia 30101
    United States

    Site Not Available

  • Morehouse School of Medicine

    Atlanta, Georgia 30310
    United States

    Site Not Available

  • Coastal Medical

    Brunswick, Georgia 31520
    United States

    Site Not Available

  • Accel Research Sites

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Georgia Clinical Research, LLC

    Lawrenceville, Georgia 30044
    United States

    Site Not Available

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia 30092
    United States

    Site Not Available

  • Elite Clinical Trials

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Meridian Family Medicine

    Meridian, Idaho 83646
    United States

    Site Not Available

  • AES Chicago/Synexus Clinical Research

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Eagle Clinical Research

    Chicago, Illinois 60621
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Healthcare Research Network - Chicago

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Koch Family Medicine, S.C

    Morton, Illinois 61550
    United States

    Site Not Available

  • Southern Illinois School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Hendricks Regional Health Medical Group - Lizton Family Medicine

    Brownsburg, Indiana 46112
    United States

    Site Not Available

  • AES Evansville/Synexus Clinical Research

    Evansville, Indiana 47714
    United States

    Site Not Available

  • ASHA Clinical Research- Munster, LLC

    Hammond, Indiana 46324
    United States

    Site Not Available

  • The Research Group of Lexington, LLC

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Nephrology Associates of Kentuckiana

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Northwest Louisiana Nephrology, LLC - Shreveport

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • ActiveMed Practices & Research LLC

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Hattiesburg Clinic

    Petal, Mississippi 39465
    United States

    Site Not Available

  • Healthcare Research Network-Hazelwood

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Clinical Research Consultants (CRC) - Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • AES - Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Henderson Clinical Trials

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Oasis Clinical Trials

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Sierra Clinical Research

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12203
    United States

    Site Not Available

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Site Not Available

  • AES New York/Synexus Clinical Research

    New York, New York 10027
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Randolph Medical Associates - Internal Medicine - Asheboro

    Asheboro, North Carolina 27203
    United States

    Active - Recruiting

  • Triad Internal Medicine

    Asheboro, North Carolina 27205
    United States

    Site Not Available

  • East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Physician's East Endocrinology

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lucas Research

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Research Innovations (Elligo Health Research)

    Beavercreek, Ohio 45431
    United States

    Site Not Available

  • Diabetes & Endocrinology Associates of Stark County

    Canton, Ohio 44240
    United States

    Site Not Available

  • Intrepid Research

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research

    Vandalia, Ohio 45377
    United States

    Site Not Available

  • Lynn Institute of Norman (LION Research)

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Willamette Valley Clinical Studies

    Eugene, Oregon 97404
    United States

    Site Not Available

  • AMS Cardiology (Elligo)

    Horsham, Pennsylvania 19044
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Pittsburg, Pennsylvania 15236
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Accelerated Enrollment Solutions (AES) - Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Wake Research - Notus Clinical Trials, LLC

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Chattanooga Medical Research

    Chattanooga, Tennessee 37412
    United States

    Site Not Available

  • AMR - Knoxville

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Lifedoc Research

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Punzi Medical Center

    Carrollton, Texas 75006
    United States

    Site Not Available

  • AES - Dallas Fort Worth

    Dallas, Texas 75234
    United States

    Site Not Available

  • David Turbay, MD, PLLC (Elligo Health Research)

    El Paso, Texas 79905
    United States

    Site Not Available

  • Gulf Coast Clinical Research

    Houston, Texas 77070
    United States

    Site Not Available

  • Juno Research, LLC

    Houston, Texas 77054
    United States

    Site Not Available

  • Synergy Groups Medical - Bissonet Site

    Houston, Texas 77036
    United States

    Site Not Available

  • Medical Colleagues of Texas, LLP (Elligo Health Research)

    Katy, Texas 77450
    United States

    Site Not Available

  • R & H Clinical Research

    Katy, Texas 77450
    United States

    Site Not Available

  • Gamma Medical Research, Inc

    McAllen, Texas 78503
    United States

    Site Not Available

  • Office of Audrey L. Jones, DO

    McAllen, Texas 78503
    United States

    Site Not Available

  • PRX Research - Mesquite

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Synergy Groups Medical - Missouri City

    Missouri City, Texas 77459
    United States

    Site Not Available

  • ACRC Trials - Legacy Medical Village

    Plano, Texas 75093
    United States

    Site Not Available

  • ACRC Trials - Legacy Medical Village Location

    Plano, Texas 75024
    United States

    Site Not Available

  • Clinical Investigations of Texas (CIT)

    Plano, Texas 75075
    United States

    Site Not Available

  • Discovery Clinical Trials

    San Antonio, Texas 78258
    United States

    Site Not Available

  • San Antonio ClinicalTrials

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Sun Research Institute (SRI) - San Antonio

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Sugar Lakes Family Practice (Elligo Health Research)

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • The University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Burke Internal Medicine

    Burke, Virginia 22015
    United States

    Site Not Available

  • Eastern VA Medical School

    Norfolk, Virginia 23501
    United States

    Site Not Available

  • Office of Ramon Mendez

    Woodbridge, Virginia 22192
    United States

    Site Not Available

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