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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: lorundrostat; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1076
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Castle Hill, Australia, NSW 2154
    • Castle Hill Medical Centre
  • Perth, Australia, 6000
    • The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.
  • Sippy Downs, Australia, QLD 4556
    • University of Sunshine Coast Clinical Trial Centre
  • Taringa, Australia, QLD 4068
    • AusTrials - Taringa
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Renal Research - Gosford
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Medical Center New Polyclinic Gabrovo Ltd.
  • Pleven, Bulgaria, 5800
    • Medical Center
  • Sofia, Bulgaria, 1582
    • ASOMHIDC - Individual practice Cardio Tonus EOOD
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD - Sofia
  • Veliko Tarnovo, Bulgaria, 5000
    • DCC 1 - Veliko Tarnovo" EOOD
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical L'Acadie - Montreal
• France
  • Annecy, France, 74370
    • Centre Hospitalier Annecy Genevois - Site d'Annecy
• Germany
  • Berlin, Germany, 10629
    • FutureMeds GmbH
  • Deggingen, Germany, 73326
    • MVZ Jung GbR
  • Dresden, Germany, 01069
    • Klinische Forschung Dresden GmbH
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • Leipzig, Germany, 04103
    • Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie
• Italy
  • Bologna, Italy, 40138
    • IRCCS AOU di Bologna - Policlinico S. Orsola
  • Ferrara, Italy, 44124
    • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
  • Genova, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino
  • Messina, Italy, 98124
    • University of Messina
  • Pisa, Italy, 56124
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00189
    • University of Rome Sapienza, AO Sant'Andrea
• Netherlands
  • Amsterdam, Netherlands, 1105
    • Amsterdam AMC
• Poland
  • Katowice, Poland, 40-029
    • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)
  • Lodz, Poland, 91-363
    • FutureMeds Lodz
  • Olsztyn, Poland, 10-117
    • ETYKA Osrodek Badan Klinicznych
  • Olsztyn, Poland, 10-010
    • FutureMeds Olsztyn
  • Skierniewice, Poland, 96-100
    • ClinMedica Research
  • Warsaw, Poland, 02-644
    • ETG Warszawa
• Puerto Rico
  • San Juan, Puerto Rico, 00909-1900
    • Latin Clinical Trial Center
• Romania
  • Brasov, Romania, 500091
    • Centrul Medical Unirea SRL Brasov (Regina Maria)
  • Bucharest, Romania, 014145
    • Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
  • Timișoara, Romania, 300723
    • Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
  • Timișoara, Romania, 300362
    • MEDICALI'S SRL Timisoara
  • Târgu Mureş, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu Mures
• Spain
  • Badajoz, Spain, 06070
    • Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
  • Córdoba, Spain, 14005
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18012
    • Hospital Universitario Virgen de Las Nieves
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario Valencia
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • Carshalton, United Kingdom, SM5
    • Epsom and St Helier University Hospitals NHS Trust
  • London, United Kingdom, EC1M 6BQ
    • Barts Health Nhs Trust
  • Plymouth, United Kingdom, PL5 3JB
    • Knowle House Surgery
  • Torpoint, United Kingdom, PL11 2TB
    • Rame Medical Limited
  • Cornwall
    • Newquay, Cornwall, United Kingdom, TR7 1RU
      • Newquay Health Centre
  • England
    • Fowey, England, United Kingdom, PL23 1DT
      • Fowey River Practice
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
  • Wilts
    • Chippenham, Wilts, United Kingdom, SN15 2SB
      • Rowden Surgery Rowden Medical Partnership
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Accel Research Sites (ARS) - Birmingham Clinical Research Unit
    • Foley, Alabama, United States, 36535
      • G & L Research LLC
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Clinical Trials
    • Glendale, Arizona, United States, 85306
      • Arizona Kidney
    • Phoenix, Arizona, United States, 85016
      • AKDHC Medical Research Services, AZ
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management, LLC
  • California
    • Beverly Hills, California, United States, 90211
      • Entertainment Medical Group, Inc
    • Chula Vista, California, United States, 91910
      • CA Institute of Renal Research, CA
    • Fairfield, California, United States, 94533
      • Amicis Research Center - Vacaville
    • Granada Hills, California, United States, 91344
      • Amicis Research Center - Granada Hills
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research 002, LLC
    • La Jolla, California, United States, 92037
      • University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
    • Lincoln, California, United States, 95648
      • Clinical Trials Research (CTR) - Lincoln
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90022
      • Academic Medical Research Institute (AMRI) - Los Angeles
    • Northridge, California, United States, 91325
      • Northridge Clinical Trials
    • Northridge, California, United States, 91324
      • Amicis Research Center-Northridge
    • Northridge, California, United States, 91324
      • Amicis Research Center - Mission Hills
    • Pasadena, California, United States, 91101
      • Pasadena Clinical Trials
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Sacramento, California, United States, 95821
      • Clinical Trials Research (CTR) - Sacramento
    • San Diego, California, United States, 92108
      • TriWest Research Associates
    • San Jose, California, United States, 95117
      • San Jose Clinical Trials
    • Valencia, California, United States, 91355
      • Amicis Research Center - Valencia
    • Victorville, California, United States, 92395
      • Kidney & Hypertension Center - Victorville
    • Vista, California, United States, 92081
      • Blue Coast Research Center (BCRC)
    • Vista, California, United States, 92083
      • Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
  • Colorado
    • Denver, Colorado, United States, 802320
      • Colorado Kidney (Denver) Nephrology
  • Connecticut
    • Hamden, Connecticut, United States, 06512
      • CMR of Greater New Haven
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Hialeah, Florida, United States, 33010
      • Qway Research
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc
    • Miami, Florida, United States, 33186
      • Nuovida Research Center Corp
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions, Inc
    • Orlando, Florida, United States, 32806
      • AES - Orlando
    • Orlando, Florida, United States, 32806-6257
      • Nephrology Associates of Central Florida
    • Pembroke Pines, Florida, United States, 33025
      • Pines Care Research Center
    • Pembroke Pines, Florida, United States, 33026
      • Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Sanford, Florida, United States, 32771
      • Infigo Clinical Research (Mid Florida)
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida, Inc.
    • The Villages, Florida, United States, 32162
      • AES The Villages
    • West Palm Beach, Florida, United States, 33401
      • Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)
  • Georgia
    • Acworth, Georgia, United States, 30101
      • American Clinical Trials
    • Atlanta, Georgia, United States, 30310
      • Morehouse School Of Medicine
    • Brunswick, Georgia, United States, 31520
      • Coastal Medical
    • Decatur, Georgia, United States, 30030
      • Accel Research Sites
    • Lawrenceville, Georgia, United States, 30044
      • Georgia Clinical Research, LLC
    • Peachtree Corners, Georgia, United States, 30092
      • Alta Pharmaceutical Research Center
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Elite Clinical Trials
    • Meridian, Idaho, United States, 83646
      • Meridian Family Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine
    • Chicago, Illinois, United States, 60621
      • Eagle Clinical Research
    • Chicago, Illinois, United States, 60602
      • AES Chicago/Synexus Clinical Research
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network - Chicago
    • Morton, Illinois, United States, 61550
      • Koch Family Medicine, S.C
    • Springfield, Illinois, United States, 62702
      • Southern Illinois School of Medicine
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Hendricks Regional Health Medical Group - Lizton Family Medicine
    • Evansville, Indiana, United States, 47714
      • AES Evansville/Synexus Clinical Research
    • Hammond, Indiana, United States, 46324
      • ASHA Clinical Research- Munster, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington, LLC
    • Louisville, Kentucky, United States, 40205
      • Nephrology Associates of Kentuckiana
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Alliance for Multispecialty Research, LLC
    • Shreveport, Louisiana, United States, 71101
      • Northwest Louisiana Nephrology, Llc - Shreveport
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Methuen, Massachusetts, United States, 01844
      • ActiveMed Practices & Research LLC
  • Mississippi
    • Petal, Mississippi, United States, 39465
      • Hattiesburg Clinic
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network-Hazelwood
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants (CRC) - Kansas City
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Synexus Clinical Research US, Inc.
    • Henderson, Nevada, United States, 89052
      • Henderson Clinical Trials
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research
    • Las Vegas, Nevada, United States, 89121
      • Oasis Clinical Trials
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10027
      • AES New York/Synexus Clinical Research
  • North Carolina
    • Asheboro, North Carolina, United States, 27205
      • Triad Internal Medicine
    • Greenville, North Carolina, United States, 27834
      • Physician's East Endocrinology
    • Greenville, North Carolina, United States, 27834
      • East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • New Bern, North Carolina, United States, 28562
      • Centricity Research New Bern Multispecialty
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Research Innovations (Elligo Health Research)
    • Canton, Ohio, United States, 44240
      • Diabetes & Endocrinology Associates of Stark County
    • Cincinnati, Ohio, United States, 45245
      • Intrepid Research
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic - Main Campus
    • Vandalia, Ohio, United States, 45377
      • Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman (LION Research)
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Willamette Valley Clinical Studies
  • Pennsylvania
    • Horsham, Pennsylvania, United States, 19044
      • AMS Cardiology (Elligo)
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Accelerated Enrollment Solutions (AES) - Anderson
    • Charleston, South Carolina, United States, 29414
      • Wake Research - Notus Clinical Trials, LLC
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37412
      • Chattanooga Medical Research
    • Knoxville, Tennessee, United States, 37920
      • AMR - Knoxville
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
    • Memphis, Tennessee, United States, 38119
      • Lifedoc Research
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center (VUMC)
  • Texas
    • Carrollton, Texas, United States, 75006
      • Punzi Medical Center
    • Dallas, Texas, United States, 75234
      • AES - Dallas Fort Worth
    • El Paso, Texas, United States, 79905
      • David Turbay, MD, PLLC (Elligo Health Research)
    • Houston, Texas, United States, 77054
      • Juno Research, LLC
    • Houston, Texas, United States, 77036
      • Synergy Groups Medical - Bissonet Site
    • Houston, Texas, United States, 77070
      • Gulf Coast Clinical Research
    • Katy, Texas, United States, 77450
      • Medical Colleagues of Texas, LLP (Elligo Health Research)
    • Katy, Texas, United States, 77450
      • R & H Clinical Research
    • McAllen, Texas, United States, 78503
      • Office of Audrey L. Jones, DO
    • McAllen, Texas, United States, 78503
      • Gamma Medical Research, Inc
    • Mesquite, Texas, United States, 75149
      • PRX Research - Mesquite
    • Missouri City, Texas, United States, 77459
      • Synergy Groups Medical - Missouri City
    • Plano, Texas, United States, 75024
      • ACRC Trials - Legacy Medical Village Location
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas (CIT)
    • Plano, Texas, United States, 75093
      • ACRC Trials - Legacy Medical Village
    • San Antonio, Texas, United States, 78258
      • Discovery Clinical Trials
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute (SRI) - San Antonio
    • San Antonio, Texas, United States, 78240
      • San Antonio ClinicalTrials
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice (Elligo Health Research)
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • The University of Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research
  • Virginia
    • Burke, Virginia, United States, 22015
      • Burke Internal Medicine
    • Norfolk, Virginia, United States, 23501
      • Eastern VA Medical School
    • Woodbridge, Virginia, United States, 22192
      • Office of Ramon Mendez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RTW Substudy; 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	Drug: lorundrostat; Tablet, administered orally; Drug: Placebo; Tablet, administered orally
Experimental: Open-Label Arm; lorundrostat once daily for 52 weeks depending on when the subject enrolled	Drug: lorundrostat; Tablet, administered orally
Experimental: Optional Continuation Period; lorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor	Drug: lorundrostat; Tablet, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in AOBP SBP in subjects taking lorundrostat at study entry	Week 0 - 48
Change in AOBP SBP in subjects taking placebo at study entry	Week 16 - 48
Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry	Week 0 - 48
Change in AOBP DBP in subjects taking placebo at study entry	Week 16 - 48
Proportion of subjects with AOBP SBP ≤130 mmHg at each visit	Through study completion, up to 54 weeks
Proportion of subjects with AOBP ≤130/80 mmHg at each visit	Through study completion, up to 54 weeks
In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP	Week 48 to Week 52
In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP	Week 48 to Week 52

Collaborators and Investigators

• Sponsor: Mineralys Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): December 30, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Hypertensive; Blood pressure; Uncontrolled hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: MLS-101-901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No