Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria

May 6, 2026 updated by: Mineralys Therapeutics Inc.

A Randomized, Crossover, Double Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors, in Adults With Hypertension and Chronic Kidney Disease With Albuminuria

This is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor [ASI]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of up to a 2-week Screening period, a 2-week run-in period where subjects will either begin study provided dapagliflozin 10 mg or continue on their regularly prescribed SGLT2i, and two DB 4-week treatment periods separated by a 4-week washout period. Subjects will be randomized (1:1) to two treatment sequences: lorundrostat-placebo (LP) and placebo-lorundrostat (PL).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
      • Phoenix, Arizona, United States, 85016
        • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
    • California
      • Chula Vista, California, United States, 91910
        • Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
      • El Centro, California, United States, 92243
        • Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
      • Granada Hills, California, United States, 91344
        • Amicis Research Center - Granada Hills
      • La Mesa, California, United States, 91942-3059
        • Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute (AMRI) - Los Angeles
      • Northridge, California, United States, 91324
        • Amicis Research Center
      • Vacaville, California, United States, 95687-3560
        • Amicis Research Center - Vacaville
    • Colorado
      • Denver, Colorado, United States, 80218-1216
        • Colorado Kidney Care (Denver Nephrology) - Denver Office
    • Florida
      • Coconut Grove, Florida, United States, 33133
        • Qway Research
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center
      • Hollywood, Florida, United States, 33024
        • Elixia Pines, LLC
      • Orlando, Florida, United States, 32806
        • Elixia Central Florida, LLC
      • Sanford, Florida, United States, 32771
        • Infigo Clinical Research, Llc
      • Tampa, Florida, United States, 33614
        • Genesis Clinical Research - Tampa
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office
    • Georgia
      • Acworth, Georgia, United States, 30101
        • American Clinical Trials LLC
      • Brunswick, Georgia, United States, 31520
        • Nephrology of the Golden Isles - Brunswick
      • Columbus, Georgia, United States, 32896
        • ClinCept, LLC
      • Lawrenceville, Georgia, United States, 30046-8761
        • Georgia Nephrology, Llc
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Nephrology Associates of Kentuckiana, PSC (NAK)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-3018
        • Lcms Health University Medical Center New Orleans
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology, LLC - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center)
    • Michigan
      • Pontiac, Michigan, United States, 48341
        • Elixia MKC, LLC
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Seacoast Kidney & Hypertension Specialists - Portsmouth Office
    • New York
      • Brooklyn, New York, United States, 11226-1508
        • Suny Downstate Medical Center - Parkside Dialysis Center
      • Fresh Meadows, New York, United States, 11365
        • Nephrology Associates
      • Fresh Meadows, New York, United States, 11365
        • Nephrology Associates, PC
    • North Carolina
      • Asheboro, North Carolina, United States, 27205
        • Triad Internal Medicine
      • Winston-Salem, North Carolina, United States, 27103
        • Nephrology Associates, Pllc - Winston-Salem
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116-1516
        • Nephrology Consultants - Oklahoma City
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Nephrology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Southeast Renal Research Institute
    • Texas
      • Dallas, Texas, United States, 75235
        • Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri)
      • Dallas, Texas, United States, 75237
        • Liberty Research Center
      • Katy, Texas, United States, 27205
        • R&H Clinical Research
      • Lufkin, Texas, United States, 75904
        • E T Nephrology Associates - Lufkin
      • Mesquite, Texas, United States, 75149
        • PRX Research
      • Mission, Texas, United States, 78572
        • Gamma Medical Research, Inc
    • Utah
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research (CCR)
    • Virginia
      • Woodbridge, Virginia, United States, 22191
        • Mendez Center for Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Major Inclusion Criteria:

  1. At Screening, UACR of 200-5000 mg/g, inclusive, in first morning urine void
  2. At Screening, eGFRs of ≥30 mL/min/1.73 m2
  3. At Screening, AOBP SBP of 135-180 mmHg, inclusive
  4. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
  5. At Screening, body mass index (BMI) of >18 kg/m2

Major Exclusion Criteria:

  1. Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
  2. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only)
  3. At Screening, serum potassium >5.0 mmol/L
  4. History of clinically significant hyponatremia within 1 year prior to Screening
  5. Use of epithelial sodium channel (ENaC) inhibitors or Mineralocorticoid receptor antagonist (MRAs), including, but not limited to amiloride, triamterene, spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visit and during study participation. With the exception of MRAs in primary aldosteronism
  6. Medical history of kidney disease related to autoimmune diseases (lupus, anti-neutrophil cytoplasmic antibody [ANCA] vasculitis), multiple myeloma or other known paraproteins, infiltrative diseases of the kidney, obstructive nephropathy, cystic kidney diseases, and renal transplantation
  7. Medical history of advanced liver disease, including cirrhosis
  8. Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
  9. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >10% (>86 mmol/mol) at Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Drug: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD
Period 1 - Lorundrostat 25mg QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Placebo QD + SGLT2i QD 4 weeks
Experimental: Cohort 2
Drug: Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Period 1 - Placebo QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Lorundrostat 25mg + SGLT2i QD 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4
Time Frame: Baseline to Week 4
Baseline to Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part A: Change from Week 12 in AOBP SBP at Week 20
Time Frame: Week 12 to Week 20
Week 12 to Week 20
Part A: Percent change from baseline in 24-hour urine albumin to creatinine ratio (UACR) at Week 8
Time Frame: baseline to Week 8
baseline to Week 8

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Placebo-adjusted percent change from baseline in 24-hour urine albumin at Study Week 4
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Placebo-adjusted change from baseline in AOBP diastolic blood pressure (DBP) at Study Week 4
Time Frame: Study Week 4
Study Week 4
Change from baseline in AOBP SBP at Study Week 4 lorundrostat treatment periods
Time Frame: Study Week 4
Study Week 4
Percent change from baseline in 24-hour urine albumin at Study Week 4 in lorundrostat treatment periods
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Placebo-adjusted percent change from baseline in 24-hour urine protein Study Week 4
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Placebo-adjusted percent change from baseline in urine albumin to creatinine ratio (UACR) at Study Week 4
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Change in biomarkers from baseline to Study Week 4 in lorundrostat treatment periods
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Placebo-adjusted percent change in estimated glomerular filtration rate (eGFR) from baseline to Study Week 4
Time Frame: baseline to Study Week 4
baseline to Study Week 4
Percent change in eGFR from Study Week 4 to Study Week 8
Time Frame: Study Week 4 to Study Week 8
Study Week 4 to Study Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mineralys Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MLS-101-206

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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