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HypertensionPhase 2NCT05769608

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

A Phase 2 study testing lorundrostat Dose 1 and lorundrostat Dose 2 in people with Hypertension, run by Mineralys Therapeutics Inc. at 104 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
lorundrostat Dose 1 and lorundrostat Dose 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
104 sitesUnited States
Study dates
13 Mar 2023to 15 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to Screening.
  • Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

United States104 sites

  • Albany Medical College Div of Community Endocrinology

    Albany, New York, 12203

  • Cambridge Clinical Trials

    Alexandria, Louisiana, 71301

  • Accelerated Enrollment Solutions (AES)- Anderson

    Anderson, South Carolina, 29621

  • Triad Internal Medicine

    Asheboro, North Carolina, 27205

  • Asheville Clinical Trials (Elite Clinical Network)

    Asheville, North Carolina, 28803

  • Nephrology Associates, PC - Downtown Augusta

    Augusta, Georgia, 30901

  • Elligo Health Research

    Austin, Texas, 78704

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Research Innovations (Elligo Health Research)

    Beavercreek, Ohio, 45431

  • Cardiology, P.C. - Birmingham

    Birmingham, Alabama, 35211

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

    Birmingham, Alabama, 35294

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • University of Buffalo

    Buffalo, New York, 14215

  • Burke Internal Medicine

    Burke, Virginia, 22015

  • Diabetes and Endocrinology Associates of Stark County, Inc.

    Canton, Ohio, 44718

  • Punzi Medical Center

    Carrollton, Texas, 75006

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

  • WR- Notus Clinical Trials, LLC

    Charleston, South Carolina, 29414

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37404

  • Eagle Clinical Research

    Chicago, Illinois, 60621

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Intrepid Research

    Cincinnati, Ohio, 45245

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80918

  • Accel Research Sites

    Decatur, Georgia, 30030

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

    Dublin, Ohio, 43016

  • Duke University Medical Center Heart Center Clinical Research Unit

    Durham, North Carolina, 27710

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

    El Paso, Texas, 79905

  • Williamette Valley Clincial Studies

    Eugene, Oregon, 97404

  • GenHarp Clinical Solutions

    Evergreen Park, Illinois, 60805

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • The Medical Research Group Inc.

    Fresno, California, 93720

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

    Greenville, North Carolina, 27834

  • CMR of Greater New Haven

    Hamden, Connecticut, 06517

  • Henderson Clinical Trials

    Henderson, Nevada, 89052

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • AMS Cardiology

    Horsham, Pennsylvania, 19044

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Juno Research LLC

    Houston, Texas, 77040

  • Gulf Coast Clinical Research

    Houston, Texas, 77070

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • Clinical Neuroscience Solutions, Inc (Jacksonville)

    Jacksonville, Florida, 32256

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

    Katy, Texas, 77450

  • Synergy Groups Medical - Bissonet Site

    Katy, Texas, 77494

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

    La Jolla, California, 92037

  • Las Vegas Clinical Trials

    Las Vegas, Nevada, 89030

  • Oasis Clinical Trials

    Las Vegas, Nevada, 89121

  • Georgia Clinical Research, LLC

    Lawrenceville, Georgia, 30044

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Clinical Trials Research

    Lincoln, California, 95648

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Lifedoc Research

    Memphis, Tennessee, 38115

  • Clinical Neuroscience Solutions, Inc

    Memphis, Tennessee, 38119

  • Indiana Clinical Research

    Merrillville, Indiana, 46410

  • Brown Road Family Medicine

    Mesa, Arizona, 85213

  • PRX Research - Mesquite

    Mesquite, Texas, 75149

  • ActivMed Practices & Research, LLC

    Methuen, Massachusetts, 01844

  • Reserka, LLC

    Miami, Florida, 33176

  • Nuovida Research Center Corp

    Miami, Florida, 33186

  • Catalina Research Institute

    Montclair, California, 91763

  • Vanderbilt University Medical Center (VUMC)

    Nashville, Tennessee, 37232

  • Lucas Research, Inc.

    New Bern, North Carolina, 28557

  • Columbia University

    New York, New York, 10032

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

    New York, New York, 11415

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Northridge Clinical Trials

    Northridge, California, 91325

  • Quality Clinical Research Inc. (QCR) - Omaha

    Omaha, Nebraska, 68114

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Clinical Neuroscience Solutions, INC.

    Orlando, Florida, 32801

  • Advanced Internal Medicine, PLLC (Elligo Health Research)

    Paducah, Kentucky, 42001

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

    Paris, Texas, 75462

  • Randomize Now

    Peachtree City, Georgia, 30269

  • Alta Pharmaceutical Research Center

    Peachtree Corners, Georgia, 30092

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

    Pembroke, Florida, 33026

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • ACRC Trials

    Plano, Texas, 75024

  • Clinical Investigations of Texas (CIT)

    Plano, Texas, 75075

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Seacoast Kidney & Hypertension Specialist

    Portsmouth, New Hampshire, 03801

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • The University of Utah

    Salt Lake City, Utah, 84108

  • Sun Research Institute (SRI) - San Antonio

    San Antonio, Texas, 78215

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240

  • Triwest Research Associates

    San Diego, California, 92108

  • San Jose Clinical Trials

    San Jose, California, 95117

  • Fellows Research Alliance, Inc

    Savannah, Georgia, 31406

  • Scottsdale Clinical Trials (Elite Clinical Network)

    Scottsdale, Arizona, 85260

  • STAT Research

    Springboro, Ohio, 45066

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62702

  • Saint Louis University

    St Louis, Missouri, 63104

  • Iredell Memorial Hospital, Inc (Elligo Health Research)

    Statesville, North Carolina, 28677

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

    Suffolk, Virginia, 23435

  • Sugar Lakes Family Practice (Elligo Health Research)

    Sugar Land, Texas, 77479

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33606

  • Fiel Family & Sports Medicine

    Tempe, Arizona, 85383

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • The Pierone Research Institute (Elligo Health Research)

    Vero Beach, Florida, 32960

  • Versailles Family Medicine

    Versailles, Kentucky, 40383

  • Blue Coast Research Center

    Vista, California, 92081

  • Accelerated Enrollment Solutions (AES)- Vista

    Vista, California, 92083

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Hypertension
Being tested
Placebo, lorundrostat Dose 1, lorundrostat Dose 2
Keywords
Blood pressure, Uncontrolled hypertension, Hypertension, Hypertensive, Resistant hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo once daily for 12 weeks

  • lorundrostat Dose 1Drug

    lorundrostat Dose 1 once daily for 12 weeks

  • lorundrostat Dose 2Drug

    lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks for subjects who meet prespecified criteria

Study groups in NCT05769608
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo once daily for 12 weeks
Receives: Drug: Placebo
Dose 1Experimentallorundrostat Dose 1 once daily for 12 weeks
Receives: Drug: lorundrostat Dose 1
Dose 2Experimentallorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks
Receives: Drug: lorundrostat Dose 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP)

    Measured: Baseline (Randomization) to Week 12

Secondary outcomes (11)

  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

    Measured: Baseline to Week 4

  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

    Measured: at Week 4

  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

    Measured: Baseline to Week 4

  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)

    Measured: Baseline to Week 12

  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

    Measured: Baseline to Week 4

  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

    Measured: Baseline to Week 12

  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

    Measured: Baseline to Week 12

  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

    Measured: Baseline to Week 4 and Week 12

  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

    Measured: Baseline to Week 4 and Week 12

  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

    Measured: Baseline to Week 4 and Week 12

  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

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2023
  2. Study start13 Mar 2023
  3. Primary completion15 Jan 2025
  4. Study completion15 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05769608
Sponsor's protocol ID
MLS-101-202
Status last verified
Jan 2026
First submitted
24 Feb 2023
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Laffin LJ, Kopjar B, Melgaard C, Wolski K, Ibbitson J, Bhikam S, Weir MR, Ofili EO, Mehra R, Luther JM, Cohen DL, Sarraju A, Wilkinson MJ, Flack JM, Rodman D, Nissen SE; Advance-HTN Investigators. Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension. N Engl J Med. 2025 May 8;392(18):1813-1823. doi: 10.1056/NEJMoa2501440. Epub 2025 Apr 23.

    PubMed 40267417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lorundrostat Dose 1 and lorundrostat Dose 2 in people with Hypertension, run by Mineralys Therapeutics Inc. at 104 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP) (time frame: Baseline (Randomization) to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05769608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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