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NCT06153693 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06153693
Other study ID # MLS-101-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 22, 2023
Est. completion date July 2025

Study information
Verified date June 2024
Source Mineralys Therapeutics Inc.
Contact Efosa Eluma
Phone +1-832-614-2778
Email eeluma@mineralystx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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 a 2-week end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date July 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. At least 18 years of age at the time of signing the informed consent form (ICF) 2. 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 3. Taking between 2 and 5 AHT medications, 4. History of hypertension lasting at least 6 months prior to Screening 5. Body mass index (BMI) of =18 kg/m2 at Screening Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant, or are breastfeeding 2. 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 3. eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula 4. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization 5. Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening. 6. History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo once daily (QD) for 12 weeks
• lorundrostat Dose 1
50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
• lorundrostat Dose 2
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

Locations
Country Name City State
Australia Castle Hill Medical Centre Castle Hill New South Wales
Australia Renal Research - Gosford Gosford New South Wales
Australia University of the Sunshine Coast - Clinical Trials Centre Sippy Downs Queensland
Australia AusTrials - Sunshine St Albans
Australia AusTrials - Taringa Taringa Queensland
Australia AusTrials - Wellers Hill Taringa Queensland
Bulgaria Medical Center New Polyclinic Gabrovo Ltd. Gabrovo
Bulgaria Medical center Exacta Medica Pleven
Bulgaria ASOMHIDC (Ambulatory of specialized outpatient medical help in internal diseases and cardiology) Sofia
Bulgaria Medical Center Hera EOOD - Sofia Sofia
Bulgaria DCC 1 - Veliko Tarnovo Veliko Tarnovo
Canada Stephen S. Chow Medicine Professional Corporation East York Ontario
Canada Centre Medical L'Acadie - Montreal Montreal Quebec
Germany emovis GmbH Berlin
Germany Gemeinscharftspraxis Dres Jung - Deggingen Deggingen
Germany kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Dresden GmbH (KFDD) Dresden Saxony
Germany kfgn Site Operations & Services GmbH (KFGN) - Klinische Forschung Hannover-Mitte GmbH (KFHM) Hannover Lower Saxony
Germany Pfuetzner Science & Health Institute GmbH (PSHI) - Diabeteszentrum & Praxis Mainz Rhineland-Palatinate
Italy Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia Brescia
Italy Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna Ferrara
Italy IRCCS Ospedale Policlinico San Martino Genova
Italy Azienda Ospedaliera Universitaria (AOU) di Napoli Napoli
Italy IRCCS San Raffaele Rome
Poland FutureMeds Sp. z o.o. FutureMeds Lodz Lódz
Poland Velocity Lublin Lubin Polska
Puerto Rico Latin Clinical Trial Center Inc. (LCTC) San Juan
Romania Centrul Medical Unirea SRL Brasov (Regina Maria) Brasov
Romania Angiocare S.R.L. (Spitalul Ares Cluj-Napoca) Cluj-Napoca
Romania Centrul Medicali's Timisoara Timisoara Timis
Spain Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques (IMIM) Barcelona
Spain Hospital Universitario Reina Sofia Córdoba
Spain Hospital Universitario Virgen de las Nieves (HUVN) Granada
Spain Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital) Santiago De Compostela
Spain Instituto de Investigacion Sanitaria (INCLIVA) Valencia
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom East Kent Hospitals University NHS Foundation Trust Canterbury
United Kingdom Epsom and St Helier University Hospitals NHS Trust Carshalton
United Kingdom Fowey River Practice - Fowey Surgery Fowey Great Britain
United Kingdom NHS Greater Glasgow and Clyde (NHSGGC) Glasgow
United Kingdom 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
United Kingdom Newquay Health Centre Newquay
United Kingdom Knowle House Surgery Plymouth Great Britain
United Kingdom The Rame Group Practice (Dr. DAVIS & Partners) - Penntorr Health Torpoint Great Britain
United States Advanced Cardiovascular, LLC - Alexander City Office Alexander City Alabama
United States Randolph Health Internal Medicine/ Triad Internal Medicine Asheboro North Carolina
United States Morehouse School of Medicine (MSM) Atlanta Georgia
United States Valley Kidney Specialists PC - Allentown Cedar Crest Bethlehem Pennsylvania
United States Entertainment Medical Group, Inc. Beverly Hills California
United States Central Research Associates, Inc Birmingham Alabama
United States Synexus (Radiant Research, Inc) - Alabama - Simon Williamson Clinic Location Birmingham Alabama
United States Elite Clinical Trials Blackfoot Idaho
United States Boston Clinical Trials (BCT) Boston Massachusetts
United States Investigators Research Group LLC Brownsburg Indiana
United States Burke Internal Medicine Burke Virginia
United States Diabetes & Endocrinology Associates of Stark County Canton Ohio
United States Punzi Medical Center and Trinity Hypertension Research Institute Carrollton Texas
United States Chattanooga Medical Research (CMR), LLC Chattanooga Tennessee
United States Synexus (Radiant Research, Inc) - Chicago Chicago Illinois
United States AES Dallas Fort Worth Dallas Texas
United States Accel Research Sites- Decatur Decatur Georgia
United States Healthcare Research Network-Chicago, Illinois (Flossmoor) Location Flossmoor Illinois
United States G & L Research LLC - Foley Foley Alabama
United States Amicis Research Center - Granada Hills Granada Hills California
United States Amicis Research Center - Northridge Granada Hills California
United States East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location Greenville North Carolina
United States Physicians East, P.A. - Endocrinology Greenville North Carolina
United States CMR of Greater New Haven Hamden Connecticut
United States Healthcare Research Network-Hazelwood Hazelwood Missouri
United States Synexus (Radiant Research, Inc) - Nevada - Rita B. Chuang, MD Henderson Nevada
United States Indago Research and Health Center Hialeah Florida
United States Juno Research, LLC Houston Texas
United States Synergy Groups Medical Houston Texas
United States Marvel Clinical Research, LLC Huntington Beach California
United States Rocky Mountain Diabetes Center Idaho Falls Idaho
United States Franciscan Physician Network Indianapolis Indiana
United States Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville Jacksonville Florida
United States Synexus (Radiant Research, Inc) - New York Jamaica New York
United States Clinical Research Consultants (CRC) - Kansas City Kansas City Missouri
United States The Alliance for Multispecialty Research LLC (AMR) - Knoxville (Volunteer Research Group) Knoxville Tennessee
United States Sierra Clinical Research-Las Vegas Las Vegas Nevada
United States Georgia Clinical Research Center, Inc Lawrenceville Georgia
United States Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky
United States Discovery Clinical Trials (DCT) - McAllen McAllen Texas
United States Clinical Neuroscience Solutions, Inc Memphis Tennessee
United States Solaris Clinical Research (SCR) Meridian Idaho
United States ActivMed Practices and Research Methuen Massachusetts
United States Nuovida Research Center Corp Miami Florida
United States Synergy Groups Medical - Missouri City Missouri City Texas
United States Carteret Medical Group - Morehead City Morehead City North Carolina
United States Koch Family Medicine, S.C. Morton Illinois
United States ASHA Clinical Research- Munster, LLC Munster Indiana
United States Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) (DEC) New Bern North Carolina
United States North Shore Diabetes and Endocrine Associates (NSDEA) - New Hyde Park New Hyde Park New York
United States The Alliance for Multispecialty Research LLC (AMR) - Louisiana New Orleans Louisiana
United States Columbia University New York New York
United States Synexus (Radiant Research, Inc) - Evansville Newburgh Indiana
United States Lynn Institute of Norman (LION Research) Norman Oklahoma
United States Amicis Research Center Northridge California
United States Quality Clinical Research Inc. (QCR) - Omaha Omaha Nebraska
United States AES Orlando Orlando Florida
United States Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center Orlando Florida
United States Pasadena Clinical Trials Pasadena California
United States Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) Pembroke Pines Florida
United States Pines Care Research Center, LLC Pembroke Pines Florida
United States Hattiesburg Clinic - Medisync Clinical Research Petal Mississippi
United States Preferred Primary Care Physicians - Pleasant Hills - Curry Hollow Rd Location Pittsburgh Pennsylvania
United States North Texas Family Medicine (NTFM) - Plano Office Plano Texas
United States Empire Clinical Research (ECR) Pomona California
United States Progressive Medical Research Port Orange Florida
United States Renown Regional Medical Center (Washoe Medical Center) Reno Nevada
United States Clinical Trials Research (CTR) - Sacramento Sacramento California
United States Global AES - Salt Lake City Salt Lake City Utah
United States Discovery Clinical Trials (DCT) - San Antonio San Antonio Texas
United States Sun Research Institute (SRI) - San Antonio San Antonio Texas
United States North America Research Institute San Dimas California
United States Grace Research, LLC Shreveport Louisiana
United States Northwest Louisiana Nephrology, LLC - Shreveport Shreveport Louisiana
United States Southern Illinois University School of Medicine - SIU Clinics - SIU Internal Medicine Springfield Illinois
United States Clinical Research of West Florida (CRWF) - Clearwater Tampa Florida
United States AES The Villages The Villages Florida
United States Del Sol Research Tucson Arizona
United States Preferred Primary Care Physicians (PPCP) - Uniontown - Jacob Murphy Lane Location Uniontown Pennsylvania
United States Amicis Research Center - Valencia Valencia California
United States Accel Research Sites (ARS) - Birmingham Clinical Research Unit Vestavia Hills Alabama
United States Velocity Clinical Research - Salt Lake City (Advanced Clinical Research) West Jordan Utah

Sponsors (1)
Lead Sponsor Collaborator
Mineralys Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Germany,  Italy,  Poland,  Puerto Rico,  Romania,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects randomized to lorundrostat Week 12
Primary Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat Dose 1 with escalation to lorundrostat Dose 2 Week 12
Secondary Proportion of subjects with AOBP SBP <130 mmHg at Week 12 in combined lorundrostat dosages Week 12
Secondary Change from baseline in AOBP SBP at Week 12 in subjects with uncontrolled hypertension in combined lorundrostat dosages Week 12
Secondary Change from baseline in AOBP SBP at Week 12 in subjects with resistant hypertension in combined lorundrostat dosages Week 12
Secondary Change from baseline in AOBP SBP at Week 12 by obesity status in combined lorundrostat dosages Week 12
Secondary Change from baseline in AOBP SBP at Week 12 in subjects who did not reach SBP control by Week 6 on lorundrostat Dose 1 and were increased to lorundrostat Dose 2 (within-subjects analysis) Week 12
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