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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.
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

Full criteria on ClinicalTrials.gov

Sites (104)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Albany Medical College Div of Community Endocrinology
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AlbanyUnited StatesUnknown status
Cambridge Clinical Trials
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AlexandriaUnited StatesUnknown status
Accelerated Enrollment Solutions (AES) - Anderson
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AndersonUnited StatesUnknown status
Triad Internal Medicine
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AsheboroUnited StatesUnknown status
Asheville Clinical Trials (Elite Clinical Network)
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AshevilleUnited StatesUnknown status
Nephrology Associates, PC - Downtown Augusta
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AugustaUnited StatesUnknown status
Elligo Health Research
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AustinUnited StatesUnknown status
Pennington Biomedical Research Center
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Baton RougeUnited StatesUnknown status
Research Innovations (Elligo Health Research)
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BeavercreekUnited StatesUnknown status
University of Alabama at Birmingham (UAB) - Vascular Biology and Hypertension Program
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BirminghamUnited StatesUnknown status
Cardiology P.C. Birmingham
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BirminghamUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
University of Buffalo
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BuffaloUnited StatesUnknown status
Burke Internal Medicine
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BurkeUnited StatesUnknown status
Diabetes And Endocrinology Associates Of Stark County, Inc.
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CantonUnited StatesUnknown status
Punzi Medical Center
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CarrolltonUnited StatesUnknown status
Chandler Clinical Trials
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ChandlerUnited StatesUnknown status
WR- Notus Clinical Trials, LLC
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CharlestonUnited StatesUnknown status
Charlottesville Medical Research
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CharlottesvilleUnited StatesUnknown status
Chattanooga Medical Research
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ChattanoogaUnited StatesUnknown status
Eagle Clinical Research
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ChicagoUnited StatesUnknown status
The University of Chicago Medicine
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ChicagoUnited StatesUnknown status
Intrepid Research
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CincinnatiUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Delta Waves, Inc.
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Colorado SpringsUnited StatesUnknown status
-
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DecaturUnited StatesUnknown status
Centricity Research (Aventiv Research) - Women's Health
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DublinUnited StatesUnknown status
Duke University Medical Center Heart Center Clinical Research Unit
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DurhamUnited StatesUnknown status
David Turbay, MD, PLLC (Elligo Health Research)
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El PasoUnited StatesUnknown status
Williamette Valley Clincial Studies
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EugeneUnited StatesUnknown status
GenHarp Clinical Solutions
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Evergreen ParkUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
The Medical Research Group, Inc.
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FresnoUnited StatesUnknown status
East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
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GreenvilleUnited StatesUnknown status
CMR of Greater New Haven
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HamdenUnited StatesUnknown status
Henderson Clinical Trials
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HendersonUnited StatesUnknown status
Indago Research & Health Center, Inc
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HialeahUnited StatesUnknown status
AMS Cardiology
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HorshamUnited StatesUnknown status
Houston Methodist Research Institute
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HoustonUnited StatesUnknown status
Gulf Coast Clinical Research
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HoustonUnited StatesUnknown status
Juno Research, LLC
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HoustonUnited StatesUnknown status
Marvel Clinical Research
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Huntington BeachUnited StatesUnknown status
Franciscan Physician Network, Indiana Heart Physicians
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IndianapolisUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc (Jacksonville)
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JacksonvilleUnited StatesUnknown status
Synergy Groups Medical - Bissonet Site
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KatyUnited StatesUnknown status
Medical Colleagues of Texas, LLP (Elligo Health Research)
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KatyUnited StatesUnknown status
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
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La JollaUnited StatesUnknown status
Las Vegas Clinical Trials
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Las VegasUnited StatesUnknown status
Oasis Clinical Trials
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Las VegasUnited StatesUnknown status
Georgia Clinical Research, LLC
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LawrencevilleUnited StatesUnknown status
The Research Group of Lexington LLC
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LexingtonUnited StatesUnknown status
Clinical Trials Research
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LincolnUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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MemphisUnited StatesUnknown status
Lifedoc Research
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MemphisUnited StatesUnknown status
Indiana Clinical Research
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MerrillvilleUnited StatesUnknown status
Brown Road Family Medicine
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MesaUnited StatesUnknown status
PRX Research - Mesquite
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MesquiteUnited StatesUnknown status
ActivMed Practices & Research, LLC
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MethuenUnited StatesUnknown status
Reserka, LLC
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MiamiUnited StatesUnknown status
Nuovida Research Center Corp
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MiamiUnited StatesUnknown status
Catalina Research Institute
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MontclairUnited StatesUnknown status
Vanderbilt University Medical Center (VUMC)
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NashvilleUnited StatesUnknown status
Lucas Research, Inc.
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New BernUnited StatesUnknown status
Marian David, MD, PC (Elligo Health Research)
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New YorkUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
Eastern Virginia Medical School
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NorfolkUnited StatesUnknown status
Coastal Carolina Research Center
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North CharlestonUnited StatesUnknown status
Northridge Clinical Trials
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NorthridgeUnited StatesUnknown status
Quality Clinical Research Inc. (QCR) - Omaha
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OmahaUnited StatesUnknown status
University of California Irvine Medical Center
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OrangeUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc.
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OrlandoUnited StatesUnknown status
Advanced Internal Medicine, PLLC (Elligo Health Research)
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PaducahUnited StatesUnknown status
Medical Colleagues of Texas, LLP (Elligo Health Research)
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ParisUnited StatesUnknown status
Randomize Now
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Peachtree CityUnited StatesUnknown status
Alta Pharmaceutical Research Center
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Peachtree CornersUnited StatesUnknown status
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
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PembrokeUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Clinical Investigations of Texas (CIT)
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PlanoUnited StatesUnknown status
ACRC Trials
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PlanoUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Seacoast Kidney & Hypertension Specialist
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PortsmouthUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
The University of Utah
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Salt Lake CityUnited StatesUnknown status
San Antonio Clinical Trials
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San AntonioUnited StatesUnknown status
Sun Research Institute (SRI) - San Antonio
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San AntonioUnited StatesUnknown status
Triwest Research Associates
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San DiegoUnited StatesUnknown status
San Jose Clinical Trials
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San JoseUnited StatesUnknown status
Fellows Research Alliance, Inc
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SavannahUnited StatesUnknown status
Scottsdale Clinical Trials (Elite Clinical Network)
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ScottsdaleUnited StatesUnknown status
STAT Research
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SpringboroUnited StatesUnknown status
Southern Illinois School of Medicine
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SpringfieldUnited StatesUnknown status
Iredell Memorial Hospital, Inc (Elligo Health Research)
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StatesvilleUnited StatesUnknown status
Saint Louis University
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St LouisUnited StatesUnknown status
Centricity Research (IACT Health) (Hampton Roads Center For Clinical Research, Inc.)) - Suffolk Multispecialty Research
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SuffolkUnited StatesUnknown status
Sugar Lakes Family Practice (Elligo Health Research)
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Sugar LandUnited StatesUnknown status
Clinical Research of West Florida Inc
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TampaUnited StatesUnknown status
Fiel Family & Sports Medicine
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TempeUnited StatesUnknown status
Noble Clinical Research
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TucsonUnited StatesUnknown status
Del Sol Research Management, LLC
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TucsonUnited StatesUnknown status
The Pierone Research Institute (Elligo Health Research)
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Vero BeachUnited StatesUnknown status
Versailles Family Medicine
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VersaillesUnited StatesUnknown status
Accelerated Enrollment Solutions (AES)- Vista
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VistaUnited StatesUnknown status
Blue Coast Research Center
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VistaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.