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

NCT06153693 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: MLS-101-301
• Study Type: interventional
• Target: 1,083
• Locations: 13 countries
• Sites: 184

Brief 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.

Conditions

Hypertension

Keywords

Blood pressure; Hypertension; Hypertensive; Resistant hypertension; Uncontrolled hypertension

Outcome Measures

Primary Outcomes (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

  Week 6

Secondary Outcomes (6)

• 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

  Week 6

• 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

  Week 12

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

  Week 6

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

  Week 6

• 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

  Week 6

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo once daily (QD) for 12 weeks

Drug: Placebo

Dose 1

EXPERIMENTAL

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

Drug: lorundrostat Dose 1

Dose 2

EXPERIMENTAL

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

Drug: lorundrostat Dose 2

Interventions

Placebo DRUG

Placebo once daily (QD) for 12 weeks

Placebo

lorundrostat Dose 1 DRUG

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

Dose 1

lorundrostat Dose 2 DRUG

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

Dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mineralys Therapeutics Inc.: lead

Study Sites (184)

Advanced Cardiovascular, LLC - Alexander City Office

Alexander City, Alabama, 35010, United States

Location

Central Research Associates, Inc

Birmingham, Alabama, 35205, United States

Location

Cardiology, P.C.

Birmingham, Alabama, 35211-1309, United States

Location

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

Birmingham, Alabama, 35211, United States

Location

G & L Research LLC - Foley

Foley, Alabama, 36535, United States

Location

Accel Research Sites (ARS) - Birmingham Clinical Research Unit

Vestavia Hills, Alabama, 35216, United States

Location

Del Sol Research

Tucson, Arizona, 85715, United States

Location

Entertainment Medical Group, Inc.

Beverly Hills, California, 90211, United States

Location

Amicis Research Center - Granada Hills

Granada Hills, California, 91344, United States

Location

Amicis Research Center - Northridge

Granada Hills, California, 91344, United States

Location

Marvel Clinical Research, LLC

Huntington Beach, California, 92647, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Pasadena Clinical Trials

Pasadena, California, 91101, United States

Location

Empire Clinical Research (ECR)

Pomona, California, 91767, United States

Location

Clinical Trials Research (CTR) - Sacramento

Sacramento, California, 95821, United States

Location

North America Research Institute

San Dimas, California, 91773, United States

Location

Amicis Research Center - Valencia

Valencia, California, 91355, United States

Location

CMR of Greater New Haven

Hamden, Connecticut, 06517, United States

Location

Chase Medical Research, LLC - Hamden

Waterbury, Connecticut, 06708-3346, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Nuovida Research Center Corp

Miami, Florida, 33175, United States

Location

Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center

Orlando, Florida, 32801, United States

Location

AES Orlando

Orlando, Florida, 32806, United States

Location

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

Pembroke Pines, Florida, 33026, United States

Location

Pines Care Research Center, LLC

Pembroke Pines, Florida, 33026, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Clinical Research of West Florida (CRWF) - Clearwater

Tampa, Florida, 33606, United States

Location

AES The Villages

The Villages, Florida, 32162, United States

Location

Morehouse School of Medicine (MSM)

Atlanta, Georgia, 30310-1458, United States

Location

ClinCept, LLC

Columbus, Georgia, 31904, United States

Location

Accel Research Sites- Decatur

Decatur, Georgia, 30030, United States

Location

Georgia Clinical Research Center, Inc

Lawrenceville, Georgia, 30044, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404-7596, United States

Location

Solaris Clinical Research (SCR)

Meridian, Idaho, 83616, United States

Location

Synexus (Radiant Research, Inc) - Chicago

Chicago, Illinois, 60602, United States

Location

Healthcare Research Network-Chicago, Illinois (Flossmoor) Location

Flossmoor, Illinois, 60422, United States

Location

Koch Family Medicine, S.C.

Morton, Illinois, 61550, United States

Location

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

Springfield, Illinois, 62702, United States

Location

Investigators Research Group LLC

Brownsburg, Indiana, 46112, United States

Location

Franciscan Physician Network

Indianapolis, Indiana, 46237-6345, United States

Location

ASHA Clinical Research- Munster, LLC

Munster, Indiana, 46321, United States

Location

Synexus (Radiant Research, Inc) - Evansville

Newburgh, Indiana, 47630, United States

Location

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, 40213, United States

Location

Tulane Doctors - Heart & Vascular - Metairie

New Orleans, Louisiana, 70112-2600, United States

Location

The Alliance for Multispecialty Research LLC (AMR) - Louisiana

New Orleans, Louisiana, 70119, United States

Location

Northwest Louisiana Nephrology, LLC - Shreveport

Shreveport, Louisiana, 71101, United States

Location

Grace Research, LLC

Shreveport, Louisiana, 71115, United States

Location

Boston Clinical Trials (BCT)

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

Hattiesburg Clinic - Medisync Clinical Research

Petal, Mississippi, 39465, United States

Location

Healthcare Research Network-Hazelwood

Hazelwood, Missouri, 63042, United States

Location

Clinical Research Consultants (CRC) - Kansas City

Kansas City, Missouri, 64111, United States

Location

Quality Clinical Research Inc. (QCR) - Omaha

Omaha, Nebraska, 68114, United States

Location

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

Henderson, Nevada, 89052, United States

Location

Sierra Clinical Research-Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Renown Regional Medical Center (Washoe Medical Center)

Reno, Nevada, 89502, United States

Location

Synexus (Radiant Research, Inc) - New York

Jamaica, New York, 11432, United States

Location

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

New Hyde Park, New York, 11042-1214, United States

Location

Columbia University

New York, New York, 10032-3725, United States

Location

Randolph Health Internal Medicine/ Triad Internal Medicine

Asheboro, North Carolina, 272205, United States

Location

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

Greenville, North Carolina, 27834, United States

Location

Physicians East, P.A. - Endocrinology

Greenville, North Carolina, 27834, United States

Location

Carteret Medical Group - Morehead City

Morehead City, North Carolina, 28557, United States

Location

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

New Bern, North Carolina, 28562, United States

Location

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

Location

Lynn Institute of Norman (LION Research)

Norman, Oklahoma, 73072, United States

Location

Valley Kidney Specialists PC - Allentown Cedar Crest

Bethlehem, Pennsylvania, 18017, United States

Location

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

Pittsburgh, Pennsylvania, 15236, United States

Location

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

Uniontown, Pennsylvania, 15401, United States

Location

Chattanooga Medical Research (CMR), LLC

Chattanooga, Tennessee, 37403, United States

Location

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

Knoxville, Tennessee, 37920, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

Punzi Medical Center and Trinity Hypertension Research Institute

Carrollton, Texas, 75006, United States

Location

AES Dallas Fort Worth

Dallas, Texas, 75234, United States

Location

Synergy Groups Medical

Houston, Texas, 77036, United States

Location

Juno Research, LLC

Houston, Texas, 77054, United States

Location

Discovery Clinical Trials (DCT) - McAllen

McAllen, Texas, 78503, United States

Location

Synergy Groups Medical - Missouri City

Missouri City, Texas, 35010, United States

Location

North Texas Family Medicine (NTFM) - Plano Office

Plano, Texas, 75093, United States

Location

Sun Research Institute (SRI) - San Antonio

San Antonio, Texas, 78215, United States

Location

Discovery Clinical Trials (DCT) - San Antonio

San Antonio, Texas, 78258, United States

Location

Global AES - Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

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

West Jordan, Utah, 84088, United States

Location

Burke Internal Medicine

Burke, Virginia, 22015, United States

Location

Eastern VA Medical School

Norfolk, Virginia, 23501, United States

Location

Castle Hill Medical Centre

Castle Hill, New South Wales, 2154, Australia

Location

Renal Research - Gosford

Gosford, New South Wales, 2250, Australia

Location

University of Newcastle - John Hunter Hospital (JHH)

Waratah, New South Wales, 2298, Australia

Location

University of the Sunshine Coast - Clinical Trials Centre

Sippy Downs, Queensland, 4556, Australia

Location

South Coast Renal

Southport, Queensland, 4215, Australia

Location

AusTrials - Taringa

Taringa, Queensland, 4068, Australia

Location

AusTrials - Wellers Hill

Taringa, Queensland, 4068, Australia

Location

Fusion Clinical Research

Adelaide, South Australia, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Dobney Hypertension Centre/ Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Austin Health - Heidelberg Repatriation Hospital

Heidelberg Heights, 3081, Australia

Location

AusTrials - Sunshine

St Albans, VIC 3021, Australia

Location

Medical Center New Polyclinic Gabrovo Ltd.

Gabrovo, 5300, Bulgaria

Location

Medical center Exacta Medica

Pleven, 5800, Bulgaria

Location

Medical Center Hera EOOD - Sofia

Sofia, 1510, Bulgaria

Location

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

Sofia, 1592, Bulgaria

Location

Medical Centre Zara-Med

Stara Zagora, 6000, Bulgaria

Location

DCC 1 - Veliko Tarnovo

Veliko Tarnovo, 5000, Bulgaria

Location

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Stephen S. Chow Medicine Professional Corporation

East York, Ontario, M4C 5T2, Canada

Location

Centre Medical L'Acadie - Montreal

Montreal, Quebec, H4N 2W2, Canada

Location

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

Annecy, 74011, France

Location

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

Bordeaux, 33000, France

Location

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

Nîmes, 30029, France

Location

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

Saint-Priest-en-Jarez, 42270, France

Location

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

Strasbourg, 67091, France

Location

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

Hanover, Lower Saxony, 30159, Germany

Location

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

Mainz, Rhineland-Palatinate, 55116, Germany

Location

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

Dresden, Saxony, 01069, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 10117, Germany

Location

emovis GmbH

Berlin, 10629, Germany

Location

Gemeinscharftspraxis Dres Jung - Deggingen

Deggingen, 73326, Germany

Location

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

Karlsruhe, Germany

Location

Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie

Leipzig, 04103, Germany

Location

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

Wiesbaden, 65191, Germany

Location

Gruppo Humanitas - Humanitas Research Hospital (Istituto Clinico Humanitas)

Rozzano, Milan, 20089, Italy

Location

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

Roma, Rome, 00189, Italy

Location

Istituto Nazionale di Riposo e Cura per Anziani (INRCA)

Ancona, 60127, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

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

Brescia, 251123, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, 44124, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

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

L’Aquila, 67100, Italy

Location

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

Messina, 98125, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

AOU Policlinico di Modena - UO Cardiologia

Modena, 41121, Italy

Location

Azienda Ospedaliera Universitaria (AOU) di Napoli

Naples, 80131, Italy

Location

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

Pavia, 27100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

IRCCS San Raffaele

Rome, 00163, Italy

Location

Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Albert Schweitzer Ziekenhuis - Sliedrecht

Dordrecht, South Holland, Netherlands

Location

Universitair Medisch Centrum (UMC) Utrecht - Locatie AZU

Utrecht, 3508 GA, Netherlands

Location

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Velocity Lublin

Lubin, Polska, 20-362, Poland

Location

Velocity Skierniewice Sp. z o.o

Skierniewice, Polska, 96-100, Poland

Location

ETG Network - Warszawa (European Trial Group)

Warsaw, Polska, 02-677, Poland

Location

Etyka OÅ>rodek BadaÅ" Klinicznych

Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland

Location

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

Katowice, 40-027, Poland

Location

Silmedic Sp. z o.o

Katowice, 40-282, Poland

Location

FutureMeds Sp. z o.o. FutureMeds Lodz

Lodz, Poland

Location

FutureMeds Sp. z o.o. Futuremeds Olsztyn

Olsztyn, 10-010, Poland

Location

Latin Clinical Trial Center Inc. (LCTC)

San Juan, 00936, Puerto Rico

Location

Spitalul Clinic Judetean de Urgenta Tg. Mures

Târgu Mureş, Mureș County, 540136, Romania

Location

Centrul Medicali's Timisoara

Timișoara, Timiș County, 300362, Romania

Location

Centrul Medical Unirea SRL Brasov (Regina Maria)

Brasov, 500091, Romania

Location

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

Bucharest, 014146, Romania

Location

Spitalul Clinic Colentina

Bucharest, 020125, Romania

Location

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

Cluj-Napoca, 400015, Romania

Location

Spitalul Clinic Municipal Filantropia Craiova

Craiova, 200508, Romania

Location

Spitalul Clinic Judetean de Urgenta Bihor

Oradea, 410169, Romania

Location

S.C Materna Care SRL Timisoara (Regina Maria)

Timișoara, 300644, Romania

Location

Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara

Timișoara, 300723, Romania

Location

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

Badajoz, 6080, Spain

Location

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

Barcelona, 8003, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Virgen de las Nieves (HUVN)

Granada, 18014, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

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

Madrid, 28040, Spain

Location

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

Santiago de Compostela, 15706, Spain

Location

Instituto de Investigacion Sanitaria (INCLIVA)

Valencia, 46010, Spain

Location

Fowey River Practice - Fowey Surgery

Fowey, Great Britain, PL23 1DT, United Kingdom

Location

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, United Kingdom

Location

Knowle House Surgery

Plymouth, Great Britain, PL5 3JB, United Kingdom

Location

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

Torpoint, Great Britain, PL11 2TB, United Kingdom

Location

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

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

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

Birmingham, B9 5SS, United Kingdom

Location

East Kent Hospitals University NHS Foundation Trust

Canterbury, CT1 3NG, United Kingdom

Location

Epsom and St Helier University Hospitals NHS Trust

Carshalton, SM5 1AA, United Kingdom

Location

Rowden Surgery Rowden Medical Partnership

Chippenham, SN15 2SB, United Kingdom

Location

NHS Greater Glasgow and Clyde (NHSGGC)

Glasgow, G12 8TA, United Kingdom

Location

Newquay Health Centre

Newquay, TR7 1RU, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

FutureMeds - Stockton-on-Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40587141 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 1, 2023
• Study Start: November 22, 2023
• Primary Completion: December 10, 2024
• Study Completion: January 24, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (15); ES (8); GB (14); DE (10); NL (4); CA (3); PL (9); US (87); BU (6); FR (5); PR (1); RO (10); AU (12)