A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

Last updated: February 14, 2025
Sponsor: Mineralys Therapeutics Inc.
Overall Status: Completed

Phase

2

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

lorundrostat Dose 1

lorundrostat Dose 2

Placebo

Clinical Study ID

NCT05769608
MLS-101-202
  • Ages > 18
  • All Genders

Study Summary

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years of age at the time of signing the informed consent form

  2. At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg

  3. 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP >80 mmHg

  4. Taking between 2 and 5 AHT medications, inclusive, at Screening visit.

  5. BMI of 18-40 kg/m2 inclusive at Screening

Exclusion

Exclusion Criteria:

  1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) formula

  2. Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization

  3. Serum sodium <135 mmol/L at Screening

  4. History of heart failure, myocardial infarction, stroke, or transient ischemicattack within 6 months prior to Screening.

  5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) atScreening

Study Design

Total Participants: 285
Treatment Group(s): 3
Primary Treatment: lorundrostat Dose 1
Phase: 2
Study Start date:
March 13, 2023
Estimated Completion Date:
January 15, 2025

Study Description

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.

Connect with a study center

  • Cardiology, P.C. - Birmingham

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Chandler Clinical Trials

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Brown Road Family Medicine

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Scottsdale Clinical Trials (Elite Clinical Network)

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • Fiel Family & Sports Medicine

    Tempe, Arizona 85383
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tuscon, Arizona 85715
    United States

    Site Not Available

  • The Medical Research Group Inc.

    Fresno, California 93720
    United States

    Site Not Available

  • Marvel Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

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

    La Jolla, California 92037
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Catalina Research Institute

    Montclair, California 91763
    United States

    Site Not Available

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Site Not Available

  • University of California Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Triwest Research Associates

    San Diego, California 92108
    United States

    Site Not Available

  • San Jose Clinical Trials

    San Jose, California 95117
    United States

    Site Not Available

  • Accelerated Enrollment Solutions (AES)- Vista

    Vista, California 92083
    United States

    Site Not Available

  • Blue Coast Research Center

    Vista, California 92081
    United States

    Site Not Available

  • Delta Waves, Inc.

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • Indago Research & Health Center, Inc.

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc (Jacksonville)

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Nuovida Research Center Corp

    Miami, Florida 33186
    United States

    Site Not Available

  • Reserka, LLC

    Miami, Florida 33176
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, INC.

    Orlando, Florida 32801
    United States

    Site Not Available

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

    Pembroke, Florida 33026
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Tampa, Florida 33606
    United States

    Site Not Available

  • The Pierone Research Institute (Elligo Health Research)

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Nephrology Associates, PC - Downtown Augusta

    Augusta, Georgia 30901
    United States

    Site Not Available

  • Accel Research Sites

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Georgia Clinical Research, LLC

    Lawrenceville, Georgia 30044
    United States

    Site Not Available

  • Randomize Now

    Peachtree City, Georgia 30269
    United States

    Site Not Available

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia 30092
    United States

    Site Not Available

  • Fellows Research Alliance, Inc

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Eagle Clinical Research

    Chicago, Illinois 60621
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois 60805
    United States

    Site Not Available

  • Southern Illinois School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Indiana Clinical Research

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • The Research Group of Lexington, LLC

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Advanced Internal Medicine, PLLC (Elligo Health Research)

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Versailles Family Medicine

    Versailles, Kentucky 40383
    United States

    Site Not Available

  • Cambridge Clinical Trials

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Saint Louis University

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Saint Louis University

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Quality Clinical Research Inc. (QCR) - Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Henderson Clinical Trials

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Las Vegas Clinical Trials

    Las Vegas, Nevada 89030
    United States

    Site Not Available

  • Oasis Clinical Trials

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Seacoast Kidney & Hypertension Specialist

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Albany Medical College Div of Community Endocrinology

    Albany, New York 12203
    United States

    Site Not Available

  • University of Buffalo

    Buffalo, New York 14215
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • Marian David, MD, PC (Elligo Health Research)

    New York, New York 11415
    United States

    Site Not Available

  • Randolph Medical Associates - Internal Medicine

    Asheboro, North Carolina 27203
    United States

    Active - Recruiting

  • Triad Internal Medicine

    Asheboro, North Carolina 27205
    United States

    Site Not Available

  • Asheville Clinical Trials (Elite Clinical Network)

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Asheville Clinical Trials (Elite Clinical Network)

    Ashville, North Carolina 28803
    United States

    Site Not Available

  • Duke University Medical Center Heart Center Clinical Research Unit

    Durham, North Carolina 27710
    United States

    Site Not Available

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

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Lucas Research, Inc.

    New Bern, North Carolina 28557
    United States

    Site Not Available

  • Iredell Memorial Hospital, Inc (Elligo Health Research)

    Statesville, North Carolina 28677
    United States

    Site Not Available

  • Lillestol Research LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Research Innovations (Elligo Health Research)

    Beavercreek, Ohio 45431
    United States

    Site Not Available

  • Diabetes and Endocrinology Associates of Stark County, Inc.

    Canton, Ohio 44718
    United States

    Site Not Available

  • Intrepid Research

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Centricity Research (Aventiv Research) - Women's Health

    Dublin, Ohio 43016
    United States

    Site Not Available

  • STAT Research

    Springboro, Ohio 45066
    United States

    Site Not Available

  • Williamette Valley Clincial Studies

    Eugene, Oregon 97404
    United States

    Site Not Available

  • AMS Cardiology

    Horsham, Pennsylvania 19044
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Accelerated Enrollment Solutions (AES)- Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • WR- Notus Clinical Trials, LLC

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Chattanooga Medical Research

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Lifedoc Research

    Memphis, Tennessee 38115
    United States

    Site Not Available

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Elligo Health Research

    Austin, Texas 78704
    United States

    Site Not Available

  • Punzi Medical Center

    Carrollton, Texas 75006
    United States

    Site Not Available

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

    El Paso, Texas 79905
    United States

    Site Not Available

  • Gulf Coast Clinical Research

    Houston, Texas 77070
    United States

    Site Not Available

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Juno Research LLC

    Houston, Texas 77040
    United States

    Site Not Available

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

    Katy, Texas 77450
    United States

    Site Not Available

  • Synergy Groups Medical - Bissonet Site

    Katy, Texas 77494
    United States

    Site Not Available

  • PRX Research - Mesquite

    Mesquite, Texas 75149
    United States

    Site Not Available

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

    Paris, Texas 75462
    United States

    Site Not Available

  • ACRC Trials

    Plano, Texas 75024
    United States

    Site Not Available

  • Clinical Investigations of Texas (CIT)

    Plano, Texas 75075
    United States

    Site Not Available

  • San Antonio Clinical Trials

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Sun Research Institute (SRI) - San Antonio

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Sugar Lakes Family Practice (Elligo Health Research)

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • The University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • Burke Internal Medicine

    Burke, Virginia 22015
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Eastern Virginia Medical School

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research

    Suffolk, Virginia 23435
    United States

    Site Not Available

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