NCT05769608CompletedPhase 2
A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 285 (actual)
- First submitted
- 24 Feb 2023
- Start date
- 13 Mar 2023
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- Mineralys Therapeutics Inc.
- Diseases
- High blood pressure
- NCT number
- NCT05769608
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 285
- From 13 Mar 2023 to the primary completion date, 15 Jan 2025
- 104 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
Lab values
- eGFR \<45 mL/min/1.73 m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Serum potassium \>5.0 mmol/L at Screening or \>4.8 mmol/L at Randomization
- Serum sodium \<135 mmol/L at Screening
- Diabetes mellitus with a glycosylated hemoglobin (HbA1c) \>9% (\>74.9 mmol/mol) at Screening
Who the study is looking for
- At least 18 years of age at the time of signing the informed consent form
- At Screening: AOBP SBP of 140-180 mmHg and AOBP DBP of 65-110 mmHg, or AOBP DBP of 90-110 mmHg
- 24-hour average ABPM SBP of 130-180 mmHg or 24-hour average ABPM DBP \>80 mmHg
- Taking between 2 and 5 AHT medications, inclusive, at Screening visit.
- BMI of 18-40 kg/m2 inclusive at Screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (104)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical College Div of Community Endocrinology Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Cambridge Clinical Trials Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Accelerated Enrollment Solutions (AES) - Anderson Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Triad Internal Medicine Coordinator of this site? Confirm its status | Asheboro | United States | Unknown status |
| Asheville Clinical Trials (Elite Clinical Network) Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Nephrology Associates, PC - Downtown Augusta Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Elligo Health Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Research Innovations (Elligo Health Research) Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Cardiology P.C. Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Buffalo Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Burke Internal Medicine Coordinator of this site? Confirm its status | Burke | United States | Unknown status |
| Diabetes And Endocrinology Associates Of Stark County, Inc. Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| Punzi Medical Center Coordinator of this site? Confirm its status | Carrollton | United States | Unknown status |
| Chandler Clinical Trials Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| WR- Notus Clinical Trials, LLC Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Charlottesville Medical Research Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Chattanooga Medical Research Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Eagle Clinical Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| The University of Chicago Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Intrepid Research Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Delta Waves, Inc. Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Centricity Research (Aventiv Research) - Women's Health Coordinator of this site? Confirm its status | Dublin | United States | Unknown status |
| Duke University Medical Center Heart Center Clinical Research Unit Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| David Turbay, MD, PLLC (Elligo Health Research) Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Williamette Valley Clincial Studies Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| GenHarp Clinical Solutions Coordinator of this site? Confirm its status | Evergreen Park | United States | Unknown status |
| Lillestol Research, LLC Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| The Medical Research Group, Inc. Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| CMR of Greater New Haven Coordinator of this site? Confirm its status | Hamden | United States | Unknown status |
| Henderson Clinical Trials Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Indago Research & Health Center, Inc Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| AMS Cardiology Coordinator of this site? Confirm its status | Horsham | United States | Unknown status |
| Houston Methodist Research Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Gulf Coast Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Juno Research, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Marvel Clinical Research Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Franciscan Physician Network, Indiana Heart Physicians Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc (Jacksonville) Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Synergy Groups Medical - Bissonet Site Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Medical Colleagues of Texas, LLP (Elligo Health Research) Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Las Vegas Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Oasis Clinical Trials Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Georgia Clinical Research, LLC Coordinator of this site? Confirm its status | Lawrenceville | United States | Unknown status |
| The Research Group of Lexington LLC Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Clinical Trials Research Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Lifedoc Research Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Indiana Clinical Research Coordinator of this site? Confirm its status | Merrillville | United States | Unknown status |
| Brown Road Family Medicine Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| PRX Research - Mesquite Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| ActivMed Practices & Research, LLC Coordinator of this site? Confirm its status | Methuen | United States | Unknown status |
| Reserka, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Nuovida Research Center Corp Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Catalina Research Institute Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Vanderbilt University Medical Center (VUMC) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| Marian David, MD, PC (Elligo Health Research) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Eastern Virginia Medical School Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Coastal Carolina Research Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| Northridge Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Quality Clinical Research Inc. (QCR) - Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of California Irvine Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Advanced Internal Medicine, PLLC (Elligo Health Research) Coordinator of this site? Confirm its status | Paducah | United States | Unknown status |
| Medical Colleagues of Texas, LLP (Elligo Health Research) Coordinator of this site? Confirm its status | Paris | United States | Unknown status |
| Randomize Now Coordinator of this site? Confirm its status | Peachtree City | United States | Unknown status |
| Alta Pharmaceutical Research Center Coordinator of this site? Confirm its status | Peachtree Corners | United States | Unknown status |
| Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) Coordinator of this site? Confirm its status | Pembroke | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Clinical Investigations of Texas (CIT) Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| ACRC Trials Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Seacoast Kidney & Hypertension Specialist Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| The University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| San Antonio Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Sun Research Institute (SRI) - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Triwest Research Associates Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| San Jose Clinical Trials Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Fellows Research Alliance, Inc Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Scottsdale Clinical Trials (Elite Clinical Network) Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| STAT Research Coordinator of this site? Confirm its status | Springboro | United States | Unknown status |
| Southern Illinois School of Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Iredell Memorial Hospital, Inc (Elligo Health Research) Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Saint Louis University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research Coordinator of this site? Confirm its status | Suffolk | United States | Unknown status |
| Sugar Lakes Family Practice (Elligo Health Research) Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Clinical Research of West Florida Inc Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Fiel Family & Sports Medicine Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
| Noble Clinical Research Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Del Sol Research Management, LLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| The Pierone Research Institute (Elligo Health Research) Coordinator of this site? Confirm its status | Vero Beach | United States | Unknown status |
| Versailles Family Medicine Coordinator of this site? Confirm its status | Versailles | United States | Unknown status |
| Accelerated Enrollment Solutions (AES)- Vista Coordinator of this site? Confirm its status | Vista | United States | Unknown status |
| Blue Coast Research Center Coordinator of this site? Confirm its status | Vista | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.