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

Phase 3

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: lorundrostat; Drug: Placebo

• 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.

Study Timeline

• Study Start: 2023-07-14
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & 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

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