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NCT05769608 Clinical Trial

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

Hypertension Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05769608
Other study ID # MLS-101-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 13, 2023
Est. completion date October 2024

Study information
Verified date June 2024
Source Mineralys Therapeutics Inc.
Contact Megan McCormick
Phone 518-727-1995
Email mmccormick@mineralystx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension.

Description:

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension. The study consists of a standardized AHT regimen run-in phase followed by a randomized, double-blind, placebo-controlled, parallel arm phase, after which subjects will enter a washout period ending with an end of study (EoS) visit. Subjects may be offered the opportunity to participate in an open-label extension (OLE). Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit to complete their participation in the study. The study will be conducted at approximately 75-100 sites across the United States.

Recruitment information / eligibility
Status Recruiting
Enrollment 261
Est. completion date October 2024
Est. primary completion date September 2024
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 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 Criteria: 1. eGFR <45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology 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 ischemic attack within 6 months prior to Screening. 5. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo once daily for 12 weeks
• lorundrostat Dose 1
lorundrostat Dose 1 once daily for 12 weeks
• lorundrostat Dose 2
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks for subjects who meet prespecified criteria

Locations
Country Name City State
United States Albany Medical College Div of Community Endocrinology Albany New York
United States Cambridge Clinical Trials Alexandria Louisiana
United States Accelerated Enrollment Solutions (AES)- Anderson Anderson South Carolina
United States Triad Internal Medicine Asheboro North Carolina
United States Asheville Clinical Trials (Elite Clinical Network) Asheville North Carolina
United States Nephrology Associates, PC - Downtown Augusta Augusta Georgia
United States Elligo Health Research Austin Texas
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States Research Innovations (Elligo Health Research) Beavercreek Ohio
United States Cardiology, P.C. - Birmingham Birmingham Alabama
United States University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program Birmingham Alabama
United States Boston Clinical Trials Boston Massachusetts
United States University of Buffalo Buffalo New York
United States Burke Internal Medicine Burke Virginia
United States Diabetes and Endocrinology Associates of Stark County, Inc. Canton Ohio
United States Punzi Medical Center Carrollton Texas
United States Chandler Clinical Trials Chandler Arizona
United States WR- Notus Clinical Trials, LLC Charleston South Carolina
United States Charlottesville Medical Research Charlottesville Virginia
United States Chattanooga Medical Research Chattanooga Tennessee
United States Eagle Clinical Research Chicago Illinois
United States The University of Chicago Medicine Chicago Illinois
United States Intrepid Research Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Delta Waves, Inc. Colorado Springs Colorado
United States Accel Research Sites Decatur Georgia
United States Centricity Research (Aventiv Research) - Women's Health Dublin Ohio
United States Duke University Medical Center Heart Center Clinical Research Unit Durham North Carolina
United States David Turbay, MD, PLLC (Elligo Health Research) El Paso Texas
United States Williamette Valley Clincial Studies Eugene Oregon
United States GenHarp Clinical Solutions Evergreen Park Illinois
United States Lillestol Research LLC Fargo North Dakota
United States The Medical Research Group Inc. Fresno California
United States East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location Greenville North Carolina
United States CMR of Greater New Haven Hamden Connecticut
United States Henderson Clinical Trials Henderson Nevada
United States Indago Research & Health Center, Inc. Hialeah Florida
United States AMS Cardiology Horsham Pennsylvania
United States Gulf Coast Clinical Research Houston Texas
United States Houston Methodist Research Institute Houston Texas
United States Juno Research LLC Houston Texas
United States Marvel Clinical Research Huntington Beach California
United States Franciscan Physician Network-Indiana Heart Physicians Indianapolis Indiana
United States Clinical Neuroscience Solutions, Inc (Jacksonville) Jacksonville Florida
United States Medical Colleagues of Texas, LLP (Elligo Health Research) Katy Texas
United States Synergy Groups Medical - Bissonet Site Katy Texas
United States University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California
United States Las Vegas Clinical Trials Las Vegas Nevada
United States Oasis Clinical Trials Las Vegas Nevada
United States Georgia Clinical Research, LLC Lawrenceville Georgia
United States The Research Group of Lexington, LLC Lexington Kentucky
United States Clinical Trials Research Lincoln California
United States Cedars-Sinai Medical Center Los Angeles California
United States Clinical Neuroscience Solutions, Inc Memphis Tennessee
United States Lifedoc Research Memphis Tennessee
United States Indiana Clinical Research Merrillville Indiana
United States Brown Road Family Medicine Mesa Arizona
United States PRX Research - Mesquite Mesquite Texas
United States ActivMed Practices & Research, LLC Methuen Massachusetts
United States Nuovida Research Center Corp Miami Florida
United States Catalina Research Institute Montclair California
United States Vanderbilt University Medical Center (VUMC) Nashville Tennessee
United States Lucas Research, Inc. New Bern North Carolina
United States Columbia University New York New York
United States Marian David, MD, PC (Elligo Health Research) New York New York
United States Eastern Virginia Medical School Norfolk Virginia
United States Coastal Carolina Research Center North Charleston South Carolina
United States Northridge Clinical Trials Northridge California
United States Quality Clinical Research Inc. (QCR) - Omaha Omaha Nebraska
United States University of California Irvine Medical Center Orange California
United States Clinical Neuroscience Solutions, INC. Orlando Florida
United States Advanced Internal Medicine, PLLC (Elligo Health Research) Paducah Kentucky
United States Medical Colleagues of Texas, LLP (Elligo Health Research) Paris Texas
United States Randomize Now Peachtree City Georgia
United States Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) Pembroke Florida
United States University of Pennsylvania Philadelphia Pennsylvania
United States ACRC Trials Plano Texas
United States Clinical Investigations of Texas (CIT) Plano Texas
United States Progressive Medical Research Port Orange Florida
United States Seacoast Kidney & Hypertension Specialist Portsmouth New Hampshire
United States Renown Regional Medical Center Reno Nevada
United States Saint Louis University Saint Louis Missouri
United States The University of Utah Salt Lake City Utah
United States San Antonio Clinical Trials San Antonio Texas
United States Sun Research Institute (SRI) - San Antonio San Antonio Texas
United States Triwest Research Associates San Diego California
United States San Jose Clinical Trials San Jose California
United States Fellows Research Alliance, Inc Savannah Georgia
United States Scottsdale Clinical Trials (Elite Clinical Network) Scottsdale Arizona
United States STAT Research Springboro Ohio
United States Southern Illinois School of Medicine Springfield Illinois
United States Iredell Memorial Hospital, Inc (Elligo Health Research) Statesville North Carolina
United States Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research Suffolk Virginia
United States Sugar Lakes Family Practice (Elligo Health Research) Sugar Land Texas
United States Clinical Research of West Florida, Inc. Tampa Florida
United States Fiel Family & Sports Medicine Tempe Arizona
United States Del Sol Research Management, LLC Tucson Arizona
United States The Pierone Research Institute (Elligo Health Research) Vero Beach Florida
United States Versailles Family Medicine Versailles Kentucky
United States Accelerated Enrollment Solutions (AES)- Vista Vista California
United States Blue Coast Research Center Vista California

Sponsors (1)
Lead Sponsor Collaborator
Mineralys Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP Baseline (Randomization) to Week 12
Secondary Change in 24-hour average ABPM SBP from baseline to Week 12, by body mass index (BMI) Baseline to Week 12
Secondary Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12
Secondary Change in daytime average ABPM SBP Baseline to Week 12
Secondary Change in automated office blood pressure (AOBP) SBP Baseline to Week 12
Secondary Change in nighttime average ABPM SBP Baseline to Week 12
Secondary Change in AOBP SBP Baseline to Week 16
Secondary Change in 24-hour average ABPM SBP from baseline to Week 12, by number of AHT medications in the standardized AHT regimen (2 vs 3) Baseline to Week 12
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