AzTrials
AzTrials

HypertensionPhase 3NCT05968430

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

A Phase 3 study testing lorundrostat in people with Hypertension, run by Mineralys Therapeutics Inc. at 177 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
lorundrostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,076 participants
Where
177 sitesin 13 countries
Study dates
14 Jul 2023to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

177 sites in 13 countries.

177 sites in 13 countries

United States128 sites

  • American Clinical Trials

    Acworth, Georgia, 30101

  • Albany Medical College

    Albany, New York, 12203

  • Accelerated Enrollment Solutions (AES) - Anderson

    Anderson, South Carolina, 29621

  • Triad Internal Medicine

    Asheboro, North Carolina, 27205

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Research Innovations (Elligo Health Research)

    Beavercreek, Ohio, 45431

  • Entertainment Medical Group, Inc

    Beverly Hills, California, 90211

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

    Birmingham, Alabama, 35216

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Hendricks Regional Health Medical Group - Lizton Family Medicine

    Brownsburg, Indiana, 46112

  • Coastal Medical

    Brunswick, Georgia, 31520

  • Erie County Medical Center

    Buffalo, New York, 14215

  • Burke Internal Medicine

    Burke, Virginia, 22015

  • Diabetes & Endocrinology Associates of Stark County

    Canton, Ohio, 44240

  • Punzi Medical Center

    Carrollton, Texas, 75006

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

  • Wake Research - Notus Clinical Trials, LLC

    Charleston, South Carolina, 29414

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37412

  • AES Chicago/Synexus Clinical Research

    Chicago, Illinois, 60602

  • Eagle Clinical Research

    Chicago, Illinois, 60621

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • CA Institute of Renal Research, CA

    Chula Vista, California, 91910

  • Intrepid Research

    Cincinnati, Ohio, 45245

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195

  • AES - Dallas Fort Worth

    Dallas, Texas, 75234

  • Accel Research Sites

    Decatur, Georgia, 30030

  • Colorado Kidney (Denver) Nephrology

    Denver, Colorado, 802320

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

    El Paso, Texas, 79905

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • AES Evansville/Synexus Clinical Research

    Evansville, Indiana, 47714

  • Amicis Research Center - Vacaville

    Fairfield, California, 94533

  • Healthcare Research Network - Chicago

    Flossmoor, Illinois, 60422

  • G & L Research LLC

    Foley, Alabama, 36535

  • Arizona Kidney

    Glendale, Arizona, 85306

  • Amicis Research Center - Granada Hills

    Granada Hills, California, 91344

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

    Greenville, North Carolina, 27834

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834

  • CMR of Greater New Haven

    Hamden, Connecticut, 06512

  • ASHA Clinical Research- Munster, LLC

    Hammond, Indiana, 46324

  • Healthcare Research Network-Hazelwood

    Hazelwood, Missouri, 63042

  • Henderson Clinical Trials

    Henderson, Nevada, 89052

  • Synexus Clinical Research US, Inc.

    Henderson, Nevada, 89052

  • Qway Research

    Hialeah, Florida, 33010

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • AMS Cardiology (Elligo)

    Horsham, Pennsylvania, 19044

  • Synergy Groups Medical - Bissonet Site

    Houston, Texas, 77036

  • Juno Research, LLC

    Houston, Texas, 77054

  • Gulf Coast Clinical Research

    Houston, Texas, 77070

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California, 92647

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Clinical Research Consultants (CRC) - Kansas City

    Kansas City, Missouri, 64111

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

    Katy, Texas, 77450

  • R & H Clinical Research

    Katy, Texas, 77450

  • AMR - Knoxville

    Knoxville, Tennessee, 37920

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

    La Jolla, California, 92037

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Oasis Clinical Trials

    Las Vegas, Nevada, 89121

  • Georgia Clinical Research, LLC

    Lawrenceville, Georgia, 30044

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Clinical Trials Research (CTR) - Lincoln

    Lincoln, California, 95648

  • Academic Medical Research Institute (AMRI) - Los Angeles

    Los Angeles, California, 90022

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Nephrology Associates of Kentuckiana

    Louisville, Kentucky, 40205

  • Gamma Medical Research, Inc

    McAllen, Texas, 78503

  • Office of Audrey L. Jones, DO

    McAllen, Texas, 78503

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Lifedoc Research

    Memphis, Tennessee, 38119

  • Meridian Family Medicine

    Meridian, Idaho, 83646

  • PRX Research - Mesquite

    Mesquite, Texas, 75149

  • ActiveMed Practices & Research LLC

    Methuen, Massachusetts, 01844

  • Nuovida Research Center Corp

    Miami, Florida, 33186

  • Synergy Groups Medical - Missouri City

    Missouri City, Texas, 77459

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Koch Family Medicine, S.C

    Morton, Illinois, 61550

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee, 37232

  • Centricity Research New Bern Multispecialty

    New Bern, North Carolina, 28562

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • AES New York/Synexus Clinical Research

    New York, New York, 10027

  • Columbia University

    New York, New York, 10032

  • Eastern VA Medical School

    Norfolk, Virginia, 23501

  • Lynn Institute of Norman (LION Research)

    Norman, Oklahoma, 73072

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030

  • Amicis Research Center - Mission Hills

    Northridge, California, 91324

  • Amicis Research Center-Northridge

    Northridge, California, 91324

  • Northridge Clinical Trials

    Northridge, California, 91325

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Nephrology Associates of Central Florida

    Orlando, Florida, 32806-6257

  • AES - Orlando

    Orlando, Florida, 32806

  • Pasadena Clinical Trials

    Pasadena, California, 91101

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia, 30092

  • Pines Care Research Center

    Pembroke Pines, Florida, 33025

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

    Pembroke Pines, Florida, 33026

  • Hattiesburg Clinic

    Petal, Mississippi, 39465

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • AKDHC Medical Research Services, AZ

    Phoenix, Arizona, 85016

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • ACRC Trials - Legacy Medical Village Location

    Plano, Texas, 75024

  • Clinical Investigations of Texas (CIT)

    Plano, Texas, 75075

  • ACRC Trials - Legacy Medical Village

    Plano, Texas, 75093

  • Empire Clinical Research

    Pomona, California, 91767

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Clinical Trials Research (CTR) - Sacramento

    Sacramento, California, 95821

  • The University of Utah

    Salt Lake City, Utah, 84132

  • Sun Research Institute (SRI) - San Antonio

    San Antonio, Texas, 78215

  • San Antonio ClinicalTrials

    San Antonio, Texas, 78240

  • Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Triwest Research Associates

    San Diego, California, 92108

  • San Jose Clinical Trials

    San Jose, California, 95117

  • Infigo Clinical Research (Mid Florida)

    Sanford, Florida, 32771

  • Northwest Louisiana Nephrology, LLC - Shreveport

    Shreveport, Louisiana, 71101

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62702

  • Sugar Lakes Family Practice (Elligo Health Research)

    Sugar Land, Texas, 77479

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • AES The Villages

    The Villages, Florida, 32162

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Amicis Research Center - Valencia

    Valencia, California, 91355

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

    Vandalia, Ohio, 45377

  • Kidney & Hypertension Center - Victorville

    Victorville, California, 92395

  • Blue Coast Research Center (BCRC)

    Vista, California, 92081

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

    Vista, California, 92083

  • Velocity Clinical Research

    West Jordan, Utah, 84088

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

    West Palm Beach, Florida, 33401

  • Office of Ramon Mendez

    Woodbridge, Virginia, 22192

Other trials in United States

United Kingdom9 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Epsom and St Helier University Hospitals NHS Trust

    Carshalton, SM5

  • Rowden Surgery Rowden Medical Partnership

    Chippenham, Wilts, SN15 2SB

  • Fowey River Practice

    Fowey, England, PL23 1DT

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF

  • Barts Health Nhs Trust

    London, EC1M 6BQ

  • Newquay Health Centre

    Newquay, Cornwall, TR7 1RU

  • Knowle House Surgery

    Plymouth, PL5 3JB

  • Rame Medical Limited

    Torpoint, PL11 2TB

Other trials in United Kingdom

Italy6 sites

  • IRCCS AOU di Bologna - Policlinico S. Orsola

    Bologna, 40138

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    Ferrara, 44124

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • University of Messina

    Messina, 98124

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • University of Rome Sapienza, AO Sant'Andrea

    Roma, 00189

Other trials in Italy

Poland6 sites

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

    Katowice, 40-029

  • Futuremeds Lodz

    Lodz, 91-363

  • Futuremeds Olsztyn

    Olsztyn, 10-010

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10-117

  • Clinmedica Research

    Skierniewice, 96-100

  • ETG Warszawa

    Warsaw, 02-644

Other trials in Poland

Australia5 sites

  • Castle Hill Medical Centre

    Castle Hill, NSW 2154

  • Renal Research - Gosford

    Gosford, New South Wales, 2250

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

    Perth, 6000

  • University of Sunshine Coast Clinical Trial Centre

    Sippy Downs, QLD 4556

  • AusTrials - Taringa

    Taringa, QLD 4068

Other trials in Australia

Bulgaria5 sites

  • Medical Center New Polyclinic Gabrovo Ltd.

    Gabrovo, 5300

  • Medical Center

    Pleven, 5800

  • Medical Center Hera EOOD - Sofia

    Sofia, 1510

  • ASOMHIDC - Individual practice Cardio Tonus EOOD

    Sofia, 1582

  • DCC 1 - Veliko Tarnovo" EOOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Germany5 sites

  • FutureMeds GmbH

    Berlin, 10629

  • MVZ Jung GbR

    Deggingen, 73326

  • Klinische Forschung Dresden GmbH

    Dresden, 01069

  • Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie

    Leipzig, 04103

  • Herzzentrum Leipzig

    Leipzig, 04289

Other trials in Germany

Romania5 sites

  • Centrul Medical Unirea SRL Brasov (Regina Maria)

    Brasov, 500091

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

    Bucharest, 014145

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Mureş, 540136

  • MEDICALI'S SRL Timisoara

    Timișoara, 300362

  • Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara

    Timișoara, 300723

Other trials in Romania

Spain4 sites

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

    Badajoz, 06070

  • Hospital Universitario Reina Sofia

    Córdoba, 14005

  • Hospital Universitario Virgen de las Nieves

    Granada, 18012

  • Hospital Clínico Universitario Valencia

    Valencia, 46010

Other trials in Spain

Canada1 site

  • Centre Medical L'Acadie - Montreal

    Montreal, Quebec, H4N 2W2

Other trials in Canada

France1 site

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Annecy, 74370

Other trials in France

Netherlands1 site

  • Amsterdam AMC

    Amsterdam, 1105

Other trials in Netherlands

Puerto Rico1 site

  • Latin Clinical Trial Center

    San Juan, 00909-1900

Other trials in Puerto Rico

About this study

Official title: 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

Read the 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.

Conditions
Hypertension
Being tested
lorundrostat, Placebo
Keywords
Blood pressure, Uncontrolled hypertension, Hypertension, Hypertensive
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lorundrostatDrug

    Tablet, administered orally

  • PlaceboDrug

    Tablet, administered orally

Study groups in NCT05968430
Study groupRoleWhat they receive
Open-Label ArmExperimentallorundrostat once daily for 52 weeks depending on when the subject enrolled
Receives: Drug: lorundrostat
RTW SubstudyExperimentallorundrostat 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
Receives: Drug: lorundrostat; Drug: Placebo
Optional Continuation PeriodExperimentallorundrostat once daily from week 52 or until marketing authorization or early termination of the trial by the sponsor
Receives: Drug: lorundrostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 36

  2. 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

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start14 Jul 2023
  3. Primary completion30 Dec 2025
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,076 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05968430
Sponsor's protocol ID
MLS-101-901
Status last verified
Jul 2026
First submitted
14 Jul 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lorundrostat in people with Hypertension, run by Mineralys Therapeutics Inc. at 177 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, United Kingdom, Italy, Poland, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from MLS-101-301 baseline automated office blood pressure (time frame: Week 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in