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COMPLETED
NCT06153693
PHASE3

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

Sponsor: Mineralys Therapeutics Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1083

Start Date

2023-11-22

Completion Date

2025-01-24

Last Updated

2026-05-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Placebo

Placebo once daily (QD) for 12 weeks

DRUG

lorundrostat Dose 1

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

DRUG

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 (184)

Advanced Cardiovascular, LLC - Alexander City Office

Alexander City, Alabama, United States

Central Research Associates, Inc

Birmingham, Alabama, United States

Cardiology, P.C.

Birmingham, Alabama, United States

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

Birmingham, Alabama, United States

G & L Research LLC - Foley

Foley, Alabama, United States

Accel Research Sites (ARS) - Birmingham Clinical Research Unit

Vestavia Hills, Alabama, United States

Del Sol Research

Tucson, Arizona, United States

Entertainment Medical Group, Inc.

Beverly Hills, California, United States

Amicis Research Center - Granada Hills

Granada Hills, California, United States

Amicis Research Center - Northridge

Granada Hills, California, United States

Marvel Clinical Research, LLC

Huntington Beach, California, United States

Amicis Research Center

Northridge, California, United States

Pasadena Clinical Trials

Pasadena, California, United States

Empire Clinical Research (ECR)

Pomona, California, United States

Clinical Trials Research (CTR) - Sacramento

Sacramento, California, United States

North America Research Institute

San Dimas, California, United States

Amicis Research Center - Valencia

Valencia, California, United States

CMR of Greater New Haven

Hamden, Connecticut, United States

Chase Medical Research, LLC - Hamden

Waterbury, Connecticut, United States

Indago Research and Health Center

Hialeah, Florida, United States

Clinical Neuroscience Solutions (CNS Healthcare) - Jacksonville

Jacksonville, Florida, United States

Nuovida Research Center Corp

Miami, Florida, United States

Clinical Neuroscience Solutions (CNS Healthcare) - Orlando Research Center

Orlando, Florida, United States

AES Orlando

Orlando, Florida, 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

Progressive Medical Research

Port Orange, Florida, United States

Clinical Research of West Florida (CRWF) - Clearwater

Tampa, Florida, United States

AES The Villages

The Villages, Florida, United States

Morehouse School of Medicine (MSM)

Atlanta, Georgia, United States

ClinCept, LLC

Columbus, Georgia, United States

Accel Research Sites- Decatur

Decatur, Georgia, United States

Georgia Clinical Research Center, Inc

Lawrenceville, Georgia, United States

Elite Clinical Trials

Blackfoot, Idaho, United States

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, United States

Solaris Clinical Research (SCR)

Meridian, Idaho, United States

Synexus (Radiant Research, Inc) - Chicago

Chicago, Illinois, United States

Healthcare Research Network-Chicago, Illinois (Flossmoor) Location

Flossmoor, Illinois, United States

Koch Family Medicine, S.C.

Morton, Illinois, United States

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

Springfield, Illinois, United States

Investigators Research Group LLC

Brownsburg, Indiana, United States

Franciscan Physician Network

Indianapolis, Indiana, United States

ASHA Clinical Research- Munster, LLC

Munster, Indiana, United States

Synexus (Radiant Research, Inc) - Evansville

Newburgh, Indiana, United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, United States

Tulane Doctors - Heart & Vascular - Metairie

New Orleans, Louisiana, United States

The Alliance for Multispecialty Research LLC (AMR) - Louisiana

New Orleans, Louisiana, United States

Northwest Louisiana Nephrology, LLC - Shreveport

Shreveport, Louisiana, United States

Grace Research, LLC

Shreveport, Louisiana, United States

Boston Clinical Trials (BCT)

Boston, Massachusetts, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Hattiesburg Clinic - Medisync Clinical Research

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 Inc. (QCR) - Omaha

Omaha, Nebraska, United States

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

Henderson, Nevada, United States

Sierra Clinical Research-Las Vegas

Las Vegas, Nevada, United States

Renown Regional Medical Center (Washoe Medical Center)

Reno, Nevada, United States

Synexus (Radiant Research, Inc) - New York

Jamaica, New York, United States

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

New Hyde Park, New York, United States

Columbia University

New York, New York, United States

Randolph Health Internal Medicine/ 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

Physicians East, P.A. - Endocrinology

Greenville, North Carolina, United States

Carteret Medical Group - Morehead City

Morehead City, North Carolina, United States

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

New Bern, North Carolina, United States

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, United States

Lynn Institute of Norman (LION Research)

Norman, Oklahoma, United States

Valley Kidney Specialists PC - Allentown Cedar Crest

Bethlehem, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

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

Uniontown, Pennsylvania, United States

Chattanooga Medical Research (CMR), LLC

Chattanooga, Tennessee, United States

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

Knoxville, Tennessee, United States

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, United States

Punzi Medical Center and Trinity Hypertension Research Institute

Carrollton, Texas, United States

AES Dallas Fort Worth

Dallas, Texas, United States

Synergy Groups Medical

Houston, Texas, United States

Juno Research, LLC

Houston, Texas, United States

Discovery Clinical Trials (DCT) - McAllen

McAllen, Texas, United States

Synergy Groups Medical - Missouri City

Missouri City, Texas, United States

North Texas Family Medicine (NTFM) - Plano Office

Plano, Texas, United States

Sun Research Institute (SRI) - San Antonio

San Antonio, Texas, United States

Discovery Clinical Trials (DCT) - San Antonio

San Antonio, Texas, United States

Global AES - Salt Lake City

Salt Lake City, Utah, United States

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

West Jordan, Utah, United States

Burke Internal Medicine

Burke, Virginia, United States

Eastern VA Medical School

Norfolk, Virginia, United States

Castle Hill Medical Centre

Castle Hill, New South Wales, Australia

Renal Research - Gosford

Gosford, New South Wales, Australia

University of Newcastle - John Hunter Hospital (JHH)

Waratah, New South Wales, Australia

University of the Sunshine Coast - Clinical Trials Centre

Sippy Downs, Queensland, Australia

South Coast Renal

Southport, Queensland, Australia

AusTrials - Taringa

Taringa, Queensland, Australia

AusTrials - Wellers Hill

Taringa, Queensland, Australia

Fusion Clinical Research

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Dobney Hypertension Centre/ Royal Perth Hospital

Perth, Western Australia, Australia

Austin Health - Heidelberg Repatriation Hospital

Heidelberg Heights, Australia

AusTrials - Sunshine

St Albans, Australia

Medical Center New Polyclinic Gabrovo Ltd.

Gabrovo, Bulgaria

And 84 more locations on ClinicalTrials.gov