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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD | Drug | Period 1 - Lorundrostat 25mg QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Placebo QD + SGLT2i QD 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4 | Baseline to Week 4 |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office | Glendale | Arizona | 85306 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805697 | Derived | Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print. |
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The study consisted of a Screening period of up to 2-weeks, a 2-week run-in period where subjects either began study provided dapagliflozin 10 mg or continued on their regularly prescribed SGLT2i, and two double-blind 4-week treatment periods separated by a 4-week washout period. Subjects were randomized (1:1) to two treatment sequences: lorundrostat-placebo (LP) and placebo-lorundrostat (PL).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Period 1 (4 weeks): Lorundrostat 25mg QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Placebo QD + SGLT2i |
| FG001 | Cohort 2 | Period 1 (4 weeks): Placebo QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Lorundrostat 25mg QD + SGLT2i |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2024 | May 6, 2026 |
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| Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD | Drug | Period 1 - Placebo QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Lorundrostat 25mg + SGLT2i QD 4 weeks |
|
| Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista | Chula Vista | California | 91910 | United States |
| Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro | El Centro | California | 92243 | United States |
| Amicis Research Center - Granada Hills | Granada Hills | California | 91344 | United States |
| Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa | La Mesa | California | 91942-3059 | United States |
| Academic Medical Research Institute (AMRI) - Los Angeles | Los Angeles | California | 90022 | United States |
| Amicis Research Center | Northridge | California | 91324 | United States |
| Amicis Research Center - Vacaville | Vacaville | California | 95687-3560 | United States |
| Colorado Kidney Care (Denver Nephrology) - Denver Office | Denver | Colorado | 80218-1216 | United States |
| Qway Research | Coconut Grove | Florida | 33133 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Elixia Pines, LLC | Hollywood | Florida | 33024 | United States |
| Elixia Central Florida, LLC | Orlando | Florida | 32806 | United States |
| Infigo Clinical Research, Llc | Sanford | Florida | 32771 | United States |
| Genesis Clinical Research - Tampa | Tampa | Florida | 33614 | United States |
| Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office | West Palm Beach | Florida | 33401 | United States |
| American Clinical Trials Llc | Acworth | Georgia | 30101 | United States |
| Nephrology of the Golden Isles - Brunswick | Brunswick | Georgia | 31520 | United States |
| ClinCept, LLC | Columbus | Georgia | 32896 | United States |
| Georgia Nephrology, Llc | Lawrenceville | Georgia | 30046-8761 | United States |
| Nephrology Associates of Kentuckiana, PSC (NAK) | Louisville | Kentucky | 40205 | United States |
| Lcms Health University Medical Center New Orleans | New Orleans | Louisiana | 70112-3018 | United States |
| Northwest Louisiana Nephrology, Llc - Shreveport | Shreveport | Louisiana | 71101 | United States |
| Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center) | Boston | Massachusetts | 02111 | United States |
| Elixia MKC, LLC | Pontiac | Michigan | 48341 | United States |
| Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City | Kansas City | Missouri | 64111 | United States |
| Seacoast Kidney & Hypertension Specialists - Portsmouth Office | Portsmouth | New Hampshire | 03801 | United States |
| Suny Downstate Medical Center - Parkside Dialysis Center | Brooklyn | New York | 11226-1508 | United States |
| Nephrology Associates, PC | Fresh Meadows | New York | 11365 | United States |
| Nephrology Associates | Fresh Meadows | New York | 11365 | United States |
| Triad Internal Medicine | Asheboro | North Carolina | 27205 | United States |
| Nephrology Associates, Pllc - Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Nephrology Consultants - Oklahoma City | Oklahoma City | Oklahoma | 73116-1516 | United States |
| Columbia Nephrology | Columbia | South Carolina | 29203 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37408 | United States |
| Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri) | Dallas | Texas | 75235 | United States |
| Liberty Research Center | Dallas | Texas | 75237 | United States |
| R&H Clinical Research | Katy | Texas | 27205 | United States |
| E T Nephrology Associates - Lufkin | Lufkin | Texas | 75904 | United States |
| Prx Research | Mesquite | Texas | 75149 | United States |
| Gamma Medical Research, Inc | Mission | Texas | 78572 | United States |
| Chrysalis Clinical Research (CCR) | St. George | Utah | 84790 | United States |
| Mendez Center for Clinical Research, LLC | Woodbridge | Virginia | 22191 | United States |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Period 1 (4 weeks): Lorundrostat 25mg QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Placebo QD + SGLT2i |
| BG001 | Cohort 2 | Period 1 (4 weeks): Placebo QD + SGLT2i; Washout (4 weeks): Placebo QD + SGLT2i; Period 2 (4 weeks): Lorundrostat 25mg QD + SGLT2i |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||||
| Seated Automated Office Blood Pressure (AOBP), Systolic | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4 | Posted | Least Squares Mean | 90% Confidence Interval | mmHg | Baseline to Week 4 |
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All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up.
Adverse events that occurred during the Washout Period were attributed to treatment administered during Treatment Period 1. Adverse events that occurred during the Safety Follow-up Period were considered TEAEs if they occurred within 14 days of the start of the Safety Follow-up Period and were attributed to administered during Treatment Period 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo, pooled across both randomization sequence cohorts | 0 | 57 | 0 | 57 | 18 | 57 |
| EG001 | Lorundrostat | Lorundrostat, pooled across both randomization sequence cohorts | 0 | 58 | 2 | 58 | 29 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 28.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 28.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Non-systematic Assessment |
| |
| Diastolic hypotension | Vascular disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Non-systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA 28.0 | Non-systematic Assessment |
|
Limitations of this study include the small sample size and short treatment duration. The 4-week primary endpoint captures short-term pharmacodynamic effects but not the durability of long-term BP lowering or renal outcomes. Second, while urinary protein reduction is a validated surrogate marker for renal risk, confirmation with eGFR slope over longer time periods will be essential.
No unpublished multi-center information may be disclosed without prior written approval from Mineralys unless no multi-center publication is submitted within eighteen (18) months of study closure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Rodman, MD Chief Medical Officer | Mineralys Therapeutics | 1-888-378-6240 | drodman@mineralystx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2025 | May 6, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000419 | Albuminuria |
| D006973 | Hypertension |
| D011507 | Proteinuria |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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