AzTrials
AzTrials

HypertensionPhase 3NCT06153693

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

A Phase 3 study testing lorundrostat Dose 1 and lorundrostat Dose 2 in people with Hypertension, run by Mineralys Therapeutics Inc. at 184 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications. 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 Dose 1 and lorundrostat Dose 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,083 participants
Where
184 sitesin 13 countries
Study dates
22 Nov 2023to 24 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • At least 18 years of age at the time of signing the informed consent form (ICF)
  • At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
  • Taking between 2 and 5 AHT medications,
  • History of hypertension lasting at least 6 months prior to Screening
  • Body mass index (BMI) of ≥18 kg/m2 at Screening

Who cannot join

  • Women who are pregnant, plan to become pregnant, or are breastfeeding
  • Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
  • eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  • Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  • Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening.
  • History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

Trial locations and contacts

184 sites in 13 countries.

184 sites in 13 countries

United States87 sites

  • Advanced Cardiovascular, LLC - Alexander City Office

    Alexander City, Alabama, 35010

  • Randolph Health Internal Medicine/ Triad Internal Medicine

    Asheboro, North Carolina, 272205

  • Morehouse School of Medicine (MSM)

    Atlanta, Georgia, 30310-1458

  • Valley Kidney Specialists PC - Allentown Cedar Crest

    Bethlehem, Pennsylvania, 18017

  • Entertainment Medical Group, Inc.

    Beverly Hills, California, 90211

  • Central Research Associates, Inc

    Birmingham, Alabama, 35205

  • Cardiology, P.C.

    Birmingham, Alabama, 35211-1309

  • Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location

    Birmingham, Alabama, 35211

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Boston Clinical Trials (BCT)

    Boston, Massachusetts, 02131

  • Investigators Research Group LLC

    Brownsburg, Indiana, 46112

  • Burke Internal Medicine

    Burke, Virginia, 22015

  • Diabetes & Endocrinology Associates of Stark County

    Canton, Ohio, 44718

  • Punzi Medical Center and Trinity Hypertension Research Institute

    Carrollton, Texas, 75006

  • Chattanooga Medical Research (CMR), LLC

    Chattanooga, Tennessee, 37403

  • Synexus (Radiant Research, Inc) - Chicago

    Chicago, Illinois, 60602

  • ClinCept, LLC

    Columbus, Georgia, 31904

  • AES Dallas Fort Worth

    Dallas, Texas, 75234

  • Accel Research Sites- Decatur

    Decatur, Georgia, 30030

  • Healthcare Research Network-Chicago, Illinois (Flossmoor) Location

    Flossmoor, Illinois, 60422

  • G & L Research LLC - Foley

    Foley, Alabama, 36535

  • Amicis Research Center - Granada Hills

    Granada Hills, California, 91344

  • Amicis Research Center - Northridge

    Granada Hills, California, 91344

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

    Greenville, North Carolina, 27834

  • Physicians East, P.A. - Endocrinology

    Greenville, North Carolina, 27834

  • CMR of Greater New Haven

    Hamden, Connecticut, 06517

  • Healthcare Research Network-Hazelwood

    Hazelwood, Missouri, 63042

  • Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD

    Henderson, Nevada, 89052

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Synergy Groups Medical

    Houston, Texas, 77036

  • Juno Research, LLC

    Houston, Texas, 77054

  • Marvel Clinical Research, LLC

    Huntington Beach, California, 92647

  • Rocky Mountain Diabetes Center

    Idaho Falls, Idaho, 83404-7596

  • Franciscan Physician Network

    Indianapolis, Indiana, 46237-6345

  • Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville

    Jacksonville, Florida, 32256

  • Synexus (Radiant Research, Inc) - New York

    Jamaica, New York, 11432

  • Clinical Research Consultants (CRC) - Kansas City

    Kansas City, Missouri, 64111

  • The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group)

    Knoxville, Tennessee, 37920

  • Sierra Clinical Research-Las Vegas

    Las Vegas, Nevada, 89106

  • Georgia Clinical Research Center, Inc

    Lawrenceville, Georgia, 30044

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213

  • Discovery Clinical Trials (DCT) - McAllen

    McAllen, Texas, 78503

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Solaris Clinical Research (SCR)

    Meridian, Idaho, 83616

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Nuovida Research Center Corp

    Miami, Florida, 33175

  • Synergy Groups Medical - Missouri City

    Missouri City, Texas, 35010

  • Carteret Medical Group - Morehead City

    Morehead City, North Carolina, 28557

  • Koch Family Medicine, S.C.

    Morton, Illinois, 61550

  • ASHA Clinical Research- Munster, LLC

    Munster, Indiana, 46321

  • Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC)

    New Bern, North Carolina, 28562

  • North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park

    New Hyde Park, New York, 11042-1214

  • Tulane Doctors - Heart & Vascular - Metairie

    New Orleans, Louisiana, 70112-2600

  • The Alliance for Multispecialty Research LLC (AMR) - Louisiana

    New Orleans, Louisiana, 70119

  • Columbia University

    New York, New York, 10032-3725

  • Synexus (Radiant Research, Inc) - Evansville

    Newburgh, Indiana, 47630

  • Eastern VA Medical School

    Norfolk, Virginia, 23501

  • Lynn Institute of Norman (LION Research)

    Norman, Oklahoma, 73072

  • Amicis Research Center

    Northridge, California, 91324

  • Quality Clinical Research Inc. (QCR) - Omaha

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center

    Orlando, Florida, 32801

  • AES Orlando

    Orlando, Florida, 32806

  • Pasadena Clinical Trials

    Pasadena, California, 91101

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

    Pembroke Pines, Florida, 33026

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33026

  • Hattiesburg Clinic - Medisync Clinical Research

    Petal, Mississippi, 39465

  • Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location

    Pittsburgh, Pennsylvania, 15236

  • North Texas Family Medicine (NTFM) - Plano Office

    Plano, Texas, 75093

  • Empire Clinical Research (ECR)

    Pomona, California, 91767

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Renown Regional Medical Center (Washoe Medical Center)

    Reno, Nevada, 89502

  • Clinical Trials Research (CTR) - Sacramento

    Sacramento, California, 95821

  • Global AES - Salt Lake City

    Salt Lake City, Utah, 84106

  • Sun Research Institute (SRI) - San Antonio

    San Antonio, Texas, 78215

  • Discovery Clinical Trials (DCT) - San Antonio

    San Antonio, Texas, 78258

  • North America Research Institute

    San Dimas, California, 91773

  • Northwest Louisiana Nephrology, LLC - Shreveport

    Shreveport, Louisiana, 71101

  • Grace Research, LLC

    Shreveport, Louisiana, 71115

  • Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine

    Springfield, Illinois, 62702

  • Clinical Research of West Florida (CRWF) - Clearwater

    Tampa, Florida, 33606

  • AES The Villages

    The Villages, Florida, 32162

  • Del Sol Research

    Tucson, Arizona, 85715

  • Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location

    Uniontown, Pennsylvania, 15401

  • Amicis Research Center - Valencia

    Valencia, California, 91355

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

    Vestavia Hills, Alabama, 35216

  • Chase Medical Research, LLC - Hamden

    Waterbury, Connecticut, 06708-3346

  • Velocity Clinical Research - Salt Lake City (Advanced Clinical Research)

    West Jordan, Utah, 84088

Other trials in United States

Italy15 sites

  • Istituto Nazionale di Riposo e Cura per Anziani (INRCA)

    Ancona, 60127

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

  • Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 251123

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

    Ferrara, 44124

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Azienda Sanitaria Locale 1 (ASL 1) - Ospedale Regionale San Salvatore

    L’Aquila, 67100

  • Universita degli Studi di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino" - Messina

    Messina, 98125

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AOU Policlinico di Modena - UO Cardiologia

    Modena, 41121

  • Azienda Ospedaliera Universitaria (AOU) di Napoli

    Naples, 80131

  • Fondazione IRCCS Policlinico San Matteo, - SC Ematologia, Dipartimento Oncoematologico

    Pavia, 27100

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliero-Universitaria Sant'Andrea Roma, Centro Ipertensione, UOC di Cardiologia

    Roma, Rome, 00189

  • IRCCS San Raffaele

    Rome, 00163

  • Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)

    Rozzano, Milan, 20089

Other trials in Italy

United Kingdom14 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • University Hospitals Birmingham NHS Foundation Trust - Birmingham Regional Severe Asthma Service (BRSAS)

    Birmingham, B9 5SS

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital (AH)

    Canterbury, Kent, CT1 3NG

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • Epsom and St Helier University Hospitals NHS Trust

    Carshalton, SM5 1AA

  • Rowden Surgery Rowden Medical Partnership

    Chippenham, SN15 2SB

  • Fowey River Practice - Fowey Surgery

    Fowey, Great Britain, PL23 1DT

  • NHS Greater Glasgow and Clyde (NHSGGC)

    Glasgow, G12 8TA

  • Queen Mary University of London (QMUL) - Barts and The London School of Medicine and Dentistry - William Harvey Research Institute (WHRI) - William Harvey Heart Centre (WHHC)

    London, Great Britain, EC1M 6BQ

  • Newquay Health Centre

    Newquay, TR7 1RU

  • Knowle House Surgery

    Plymouth, Great Britain, PL5 3JB

  • Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital

    Sheffield, S5 7AU

  • FutureMeds - Stockton-on-Tees

    Stockton-on-Tees, TS19 8PE

  • The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health

    Torpoint, Great Britain, PL11 2TB

Other trials in United Kingdom

Australia12 sites

  • Fusion Clinical Research

    Adelaide, South Australia

  • Castle Hill Medical Centre

    Castle Hill, New South Wales, 2154

  • Renal Research - Gosford

    Gosford, New South Wales, 2250

  • Austin Health - Heidelberg Repatriation Hospital

    Heidelberg Heights, 3081

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Dobney Hypertension Centre/ Royal Perth Hospital

    Perth, Western Australia, 6000

  • University of the Sunshine Coast - Clinical Trials Centre

    Sippy Downs, Queensland, 4556

  • South Coast Renal

    Southport, Queensland, 4215

  • AusTrials - Sunshine

    St Albans, VIC 3021

  • AusTrials - Taringa

    Taringa, Queensland, 4068

  • AusTrials - Wellers Hill

    Taringa, Queensland, 4068

  • University of Newcastle - John Hunter Hospital (JHH)

    Waratah, New South Wales, 2298

Other trials in Australia

Germany10 sites

  • Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 10117

  • emovis GmbH

    Berlin, 10629

  • Gemeinscharftspraxis Dres Jung - Deggingen

    Deggingen, 73326

  • kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD)

    Dresden, Saxony, 01069

  • kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM)

    Hanover, Lower Saxony, 30159

  • kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Karlsruhe GmbH (KFKA)

    Karlsruhe

  • Herzzentrum Leipzig

    Leipzig, Saxony, 04289

  • Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie

    Leipzig, 04103

  • Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis

    Mainz, Rhineland-Palatinate, 55116

  • KfH Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum Klaus-Ketzler-Zentrum

    Wiesbaden, 65191

Other trials in Germany

Romania10 sites

  • Centrul Medical Unirea SRL Brasov (Regina Maria)

    Brasov, 500091

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

    Bucharest, 014146

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Angiocare S.R.L. (Spitalul Ares Cluj-Napoca)

    Cluj-Napoca, 400015

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200508

  • Spitalul Clinic Judetean de Urgenta Bihor

    Oradea, 410169

  • Spitalul Clinic Judetean de Urgenta Tg. Mures

    Târgu Mureş, Mureș County, 540136

  • Centrul Medicali's Timisoara

    Timișoara, Timiș County, 300362

  • S.C Materna Care SRL Timisoara (Regina Maria)

    Timișoara, 300644

  • Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara

    Timișoara, 300723

Other trials in Romania

Poland9 sites

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-027

  • Silmedic Sp. z o.o

    Katowice, 40-282

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    Krakow, Lesser Poland Voivodeship, 31-559

  • FutureMeds Sp. z o.o. FutureMeds Lodz

    Lodz

  • Velocity Lublin

    Lubin, Polska, 20-362

  • Etyka OÅ>rodek BadaÅ" Klinicznych

    Olsztyn, Warmian-Masurian Voivodeship, 10-117

  • FutureMeds Sp. z o.o. Futuremeds Olsztyn

    Olsztyn, 10-010

  • Velocity Skierniewice Sp. z o.o

    Skierniewice, Polska, 96-100

  • ETG Network - Warszawa (European Trial Group)

    Warsaw, Polska, 02-677

Other trials in Poland

Spain8 sites

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

    Badajoz, 6080

  • Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM)

    Barcelona, 8003

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves (HUVN)

    Granada, 18014

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) - Instituto de Investigacion Sanitaria (IIS)

    Madrid, 28040

  • Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)

    Santiago de Compostela, 15706

  • Instituto de Investigacion Sanitaria (INCLIVA)

    Valencia, 46010

Other trials in Spain

Bulgaria6 sites

  • Medical Center New Polyclinic Gabrovo Ltd.

    Gabrovo, 5300

  • Medical center Exacta Medica

    Pleven, 5800

  • Medical Center Hera EOOD - Sofia

    Sofia, 1510

  • ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology)

    Sofia, 1592

  • Medical Centre Zara-Med

    Stara Zagora, 6000

  • DCC 1 - Veliko Tarnovo

    Veliko Tarnovo, 5000

Other trials in Bulgaria

France5 sites

  • Centre Hospitalier Annecy Genevois (CHANGE) - Site d'Annecy -

    Annecy, 74011

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre

    Bordeaux, 33000

  • Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

    Nîmes, 30029

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)

    Strasbourg, 67091

Other trials in France

Netherlands4 sites

  • Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)

    Amsterdam, North Holland, 1105 AZ

  • Albert Schweitzer Ziekenhuis - Sliedrecht

    Dordrecht, South Holland

  • Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

    Nijmegen, Gelderland, 6525 GA

  • Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU

    Utrecht, 3508 GA

Other trials in Netherlands

Canada3 sites

  • Stephen S. Chow Medicine Professional Corporation

    East York, Ontario, M4C 5T2

  • University of Alberta

    Edmonton, Alberta, T6G 2G3

  • Centre Medical L'Acadie - Montreal

    Montreal, Quebec, H4N 2W2

Other trials in Canada

Puerto Rico1 site

  • Latin Clinical Trial Center Inc. (LCTC)

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Read the detailed description

This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications, one of which must be a thiazide or thiazide-like diuretic.

The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study. Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

Conditions
Hypertension
Being tested
Placebo, lorundrostat Dose 1, lorundrostat Dose 2
Keywords
Blood pressure, Hypertension, Hypertensive, Resistant hypertension, Uncontrolled hypertension
Medical subject headings
Hypertension

What participants receive

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

  • PlaceboDrug

    Placebo once daily (QD) for 12 weeks

  • lorundrostat Dose 1Drug

    50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks

  • lorundrostat Dose 2Drug

    50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria

Study groups in NCT06153693
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo once daily (QD) for 12 weeks
Receives: Drug: Placebo
Dose 1Experimental50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
Receives: Drug: lorundrostat Dose 1
Dose 2Experimental50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria
Receives: Drug: lorundrostat Dose 2

What is being measured

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

  1. Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Measured: Week 6

Secondary outcomes (6)

  1. Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Measured: Week 6

  2. Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QD with escalation to lorundrostat 100 mg QD compared to subjects randomized to placebo

    Measured: Week 12

  3. Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications

    Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placebo

    Measured: Week 6

  4. Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications

    Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placebo

    Measured: Week 6

  5. Change from baseline in AOBP SBP at Week 6 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo

    Measured: Week 6

  6. Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at week 6 (within-subjects analysis)

    Measured: Week 12

Timeline

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

  1. First posted1 Dec 2023
  2. Study start22 Nov 2023
  3. Primary completion10 Dec 2024
  4. Study completion24 Jan 2025

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06153693
Sponsor's protocol ID
MLS-101-301
Status last verified
Apr 2026
First submitted
17 Nov 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Saxena M, Laffin L, Borghi C, Fernandez Fernandez B, Ghali JK, Kopjar B, Polu K, Roger SD, Slingsby BT, Strutz F, Vogt L, Weir MR, Rodman D; Launch-HTN Investigators. Lorundrostat in Participants With Uncontrolled Hypertension and Treatment-Resistant Hypertension: The Launch-HTN Randomized Clinical Trial. JAMA. 2025 Aug 5;334(5):409-418. doi: 10.1001/jama.2025.9413.

    PubMed 40587141

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lorundrostat Dose 1 and lorundrostat Dose 2 in people with Hypertension, run by Mineralys Therapeutics Inc. at 184 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Italy, United Kingdom, Australia, Germany 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo (time frame: Week 6). 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 NCT06153693, which also lists 1 linked publication.

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 1 May 2026.

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