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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified December 2025 by Mineralys Therapeutics Inc.
Sponsor
Mineralys Therapeutics Inc.
Information Provided by (Responsible Party)
Mineralys Therapeutics Inc.
Clinicaltrials.gov Identifier
NCT05769608
Other Study ID Numbers:
MLS-101-202
First Submitted
February 23, 2023
First Posted
March 14, 2023
Last Update Posted
January 19, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Hypertension
Drug: PlaceboDrug: lorundrostat Dose 1Drug: lorundrostat Dose 2

Study Design

Study TypeInterventional
Actual Enrollment285 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 12, 2023
Actual Primary Completion DateJanuary 14, 2025
Actual Study Completion DateJanuary 14, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Placebo
Placebo once daily for 12 weeks
Drug: Placebo
Placebo once daily for 12 weeks
Dose 1
lorundrostat Dose 1 once daily for 12 weeks
Drug: lorundrostat Dose 1
lorundrostat Dose 1 once daily for 12 weeks
Dose 2
lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks
Drug: 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

Outcome Measures

Primary Outcome Measures
  1. Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP)
Secondary Outcome Measures
  1. Change from baseline in 24-hour average ABPM SBP at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo
  2. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 4 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo
  3. Change from baseline in 24-hour average ABPM SBP at Week 4 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo
  4. Change from baseline in automated office BP (AOBP) SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at Week 4 (within-subjects analysis)
  5. Change from baseline in 24-hour average ABPM SBP at Week 4, by number of AHT medications in the standardized AHT regimen (2 and 3) in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placebo
  6. Proportion of subjects with 24-hour average ABPM SBP <125 mmHg at Week 12 in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo
  7. Change from baseline in 24-hour average ABPM SBP at Week 12 by obesity status in subjects randomized to lorundrostat (by arm and pooled dosages) compared to subjects randomized to placebo
  8. Change from baseline in daytime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo
  9. Change from baseline in AOBP SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo
  10. Change from baseline in nighttime average ABPM SBP at Week 4 and Week 12 in subjects randomized to lorundrostat 50 mg QD (Week 4) and by arm and pooled dosages (Week 12) compared to subjects randomized to placebo
  11. Change from baseline in 24-hour average ABPM SBP at Week 12, in subjects randomized to lorundrostat (pooled dosages) compared to subjects randomized to placebo

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsMineralys Therapeutics Inc.
Locations
Cardiology, P.C. - Birmingham | Birmingham Alabama, United States, 35211University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program | Birmingham Alabama, United States, 35294Chandler Clinical Trials | Chandler Arizona, United States, 85224Brown Road Family Medicine | Mesa Arizona, United States, 85213Scottsdale Clinical Trials (Elite Clinical Network) | Scottsdale Arizona, United States, 85260Fiel Family & Sports Medicine | Tempe Arizona, United States, 85383Noble Clinical Research | Tucson Arizona, United States, 85704Del Sol Research Management, LLC | Tucson Arizona, United States, 85715The Medical Research Group Inc. | Fresno California, United States, 93720Marvel Clinical Research | Huntington Beach California, United States, 92647University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) | La Jolla California, United States, 92037Clinical Trials Research | Lincoln California, United States, 95648Cedars-Sinai Medical Center | Los Angeles California, United States, 90048Catalina Research Institute | Montclair California, United States, 91763Northridge Clinical Trials | Northridge California, United States, 91325University of California Irvine Medical Center | Orange California, United States, 92868Triwest Research Associates | San Diego California, United States, 92108San Jose Clinical Trials | San Jose California, United States, 95117Blue Coast Research Center | Vista California, United States, 92081Accelerated Enrollment Solutions (AES)- Vista | Vista California, United States, 92083Delta Waves, Inc. | Colorado Springs Colorado, United States, 80918CMR of Greater New Haven | Hamden Connecticut, United States, 06517Indago Research & Health Center, Inc. | Hialeah Florida, United States, 33012Clinical Neuroscience Solutions, Inc (Jacksonville) | Jacksonville Florida, United States, 32256Reserka, LLC | Miami Florida, United States, 33176Nuovida Research Center Corp | Miami Florida, United States, 33186Clinical Neuroscience Solutions, INC. | Orlando Florida, United States, 32801Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) | Pembroke Florida, United States, 33026Progressive Medical Research | Port Orange Florida, United States, 32127Clinical Research of West Florida, Inc. | Tampa Florida, United States, 33606The Pierone Research Institute (Elligo Health Research) | Vero Beach Florida, United States, 32960Nephrology Associates, PC - Downtown Augusta | Augusta Georgia, United States, 30901Accel Research Sites | Decatur Georgia, United States, 30030Georgia Clinical Research, LLC | Lawrenceville Georgia, United States, 30044Randomize Now | Peachtree City Georgia, United States, 30269Alta Pharmaceutical Research Center | Peachtree Corners Georgia, United States, 30092Fellows Research Alliance, Inc | Savannah Georgia, United States, 31406Eagle Clinical Research | Chicago Illinois, United States, 60621The University of Chicago Medicine | Chicago Illinois, United States, 60637GenHarp Clinical Solutions | Evergreen Park Illinois, United States, 60805Southern Illinois School of Medicine | Springfield Illinois, United States, 62702Franciscan Physician Network-Indiana Heart Physicians | Indianapolis Indiana, United States, 46237Indiana Clinical Research | Merrillville Indiana, United States, 46410The Research Group of Lexington, LLC | Lexington Kentucky, United States, 40503Advanced Internal Medicine, PLLC (Elligo Health Research) | Paducah Kentucky, United States, 42001Versailles Family Medicine | Versailles Kentucky, United States, 40383Cambridge Clinical Trials | Alexandria Louisiana, United States, 71301Pennington Biomedical Research Center | Baton Rouge Louisiana, United States, 70808Boston Clinical Trials | Boston Massachusetts, United States, 02131ActivMed Practices & Research, LLC | Methuen Massachusetts, United States, 01844Saint Louis University | St Louis Missouri, United States, 63104Quality Clinical Research Inc. (QCR) - Omaha | Omaha Nebraska, United States, 68114Henderson Clinical Trials | Henderson Nevada, United States, 89052Las Vegas Clinical Trials | Las Vegas Nevada, United States, 89030Oasis Clinical Trials | Las Vegas Nevada, United States, 89121Renown Regional Medical Center | Reno Nevada, United States, 89502Seacoast Kidney & Hypertension Specialist | Portsmouth New Hampshire, United States, 03801Albany Medical College Div of Community Endocrinology | Albany New York, United States, 12203University of Buffalo | Buffalo New York, United States, 14215Columbia University | New York New York, United States, 10032Marian David, MD, PC (Elligo Health Research) | New York New York, United States, 11415Triad Internal Medicine | Asheboro North Carolina, United States, 27205Asheville Clinical Trials (Elite Clinical Network) | Asheville North Carolina, United States, 28803Duke University Medical Center Heart Center Clinical Research Unit | Durham North Carolina, United States, 27710East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location | Greenville North Carolina, United States, 27834Lucas Research, Inc. | New Bern North Carolina, United States, 28557Iredell Memorial Hospital, Inc (Elligo Health Research) | Statesville North Carolina, United States, 28677Lillestol Research LLC | Fargo North Dakota, United States, 58104Research Innovations (Elligo Health Research) | Beavercreek Ohio, United States, 45431Diabetes and Endocrinology Associates of Stark County, Inc. | Canton Ohio, United States, 44718Intrepid Research | Cincinnati Ohio, United States, 45245Cleveland Clinic | Cleveland Ohio, United States, 44195Centricity Research (Aventiv Research) - Women's Health | Dublin Ohio, United States, 43016STAT Research | Springboro Ohio, United States, 45066Williamette Valley Clincial Studies | Eugene Oregon, United States, 97404AMS Cardiology | Horsham Pennsylvania, United States, 19044University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Accelerated Enrollment Solutions (AES)- Anderson | Anderson South Carolina, United States, 29621WR- Notus Clinical Trials, LLC | Charleston South Carolina, United States, 29414Coastal Carolina Research Center | North Charleston South Carolina, United States, 29405Chattanooga Medical Research | Chattanooga Tennessee, United States, 37404Lifedoc Research | Memphis Tennessee, United States, 38115Clinical Neuroscience Solutions, Inc | Memphis Tennessee, United States, 38119Vanderbilt University Medical Center (VUMC) | Nashville Tennessee, United States, 37232Elligo Health Research | Austin Texas, United States, 78704Punzi Medical Center | Carrollton Texas, United States, 75006David Turbay, MD, PLLC (Elligo Health Research) | El Paso Texas, United States, 79905Houston Methodist Research Institute | Houston Texas, United States, 77030Juno Research LLC | Houston Texas, United States, 77040Gulf Coast Clinical Research | Houston Texas, United States, 77070Medical Colleagues of Texas, LLP (Elligo Health Research) | Katy Texas, United States, 77450Synergy Groups Medical - Bissonet Site | Katy Texas, United States, 77494PRX Research - Mesquite | Mesquite Texas, United States, 75149Medical Colleagues of Texas, LLP (Elligo Health Research) | Paris Texas, United States, 75462ACRC Trials | Plano Texas, United States, 75024Clinical Investigations of Texas (CIT) | Plano Texas, United States, 75075Sun Research Institute (SRI) - San Antonio | San Antonio Texas, United States, 78215San Antonio Clinical Trials | San Antonio Texas, United States, 78240Sugar Lakes Family Practice (Elligo Health Research) | Sugar Land Texas, United States, 77479The University of Utah | Salt Lake City Utah, United States, 84108Burke Internal Medicine | Burke Virginia, United States, 22015Charlottesville Medical Research | Charlottesville Virginia, United States, 22911Eastern Virginia Medical School | Norfolk Virginia, United States, 23510Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research | Suffolk Virginia, United States, 23435