Chronic Kidney DiseasePhase 2NCT06150924

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

A Phase 2 study of Chronic Kidney Disease, run by Mineralys Therapeutics Inc. at 44 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 44 sitesUnited States
Study dates: 14 Dec 2023to 23 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Major Inclusion Criteria:

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

Major Exclusion Criteria:

Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients (subjects beginning dapagliflozin only)
At Screening, serum potassium >5.0 mmol/L
History of clinically significant hyponatremia within 1 year prior to Screening
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
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
Medical history of advanced liver disease, including cirrhosis
Medical history of active autoimmune disease or recent (within 30 days) or anticipated need for immunosuppressive therapy
Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >10% (>86 mmol/mol) at Screening

Trial locations and contacts

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions: Chronic Kidney Disease
Being tested: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD, Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD
Keywords: Albuminuria, Arterial hypertension, Hypertension, Proteinuria, Diabetic nephropathy, Chronic Kidney Disease, Aldosterone Synthase Inhibitor
Medical subject headings: Renal Insufficiency, Chronic, Albuminuria, Hypertension, Proteinuria, Diabetic Nephropathies

What participants receive

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

Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QDDrug
Period 1 - Lorundrostat 25mg QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Placebo QD + SGLT2i QD 4 weeks
Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QDDrug
Period 1 - Placebo QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Lorundrostat 25mg + SGLT2i QD 4 weeks

Study groups in NCT06150924
Study group	Role	What they receive
Cohort 1	Experimental	Not described Receives: Drug: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD
Cohort 2	Experimental	Not described Receives: Drug: Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD

What is being measured

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

Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4
Measured: Baseline to Week 4

Timeline

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

14 Dec 202323 Apr 2025

First posted29 Nov 2023
Study start14 Dec 2023
Primary completion27 Feb 2025
Study completion23 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06150924
Sponsor's protocol ID: MLS-101-206
Status last verified: May 2026
First submitted: 17 Nov 2023
Last updated: 3 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Weir MR, Bhaduri S, Lee K, Galvez O, Kooienga L, Kopjar B, Novin M, Rodman D; Explore-CKD Trial Group. Results from the Phase 2 Explore-CKD Trial of lorundrostat, a novel aldosterone synthase inhibitor, in participants with uncontrolled hypertension, chronic kidney disease, and albuminuria. Kidney Int. 2026 Sep 23:S0085-2538(26)00808-2. doi: 10.1016/j.kint.2026.08.021. Online ahead of print.
PubMed 42778148
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.
PubMed 41805697

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06150924
Acronym / sponsor ID: MLS-101-206
Conditions: Chronic Kidney Disease
Keywords: Albuminuria, Arterial hypertension, Hypertension, Proteinuria, Diabetic nephropathy, Chronic Kidney Disease, Aldosterone Synthase Inhibitor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Mineralys Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 14 Dec 2023 (actual)
Primary completion: 27 Feb 2025 (actual)
Study completion: 23 Apr 2025 (actual)
First posted: 29 Nov 2023 (actual)
Results: Posted 3 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QD
Cohort 2	Experimental	Drug: Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lorundrostat 25mg+SGLT2i QD, Washout, Placebo+SGLT2i QDPeriod 1 - Lorundrostat 25mg QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Placebo QD + SGLT2i QD 4 weeks	Drug	Cohort 1
Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QDPeriod 1 - Placebo QD + SGLT2i QD 4 weeks; Washout - Placebo QD + SGLT2i QD 4 weeks; Period 2 - Lorundrostat 25mg + SGLT2i QD 4 weeks	Drug	Cohort 2

Primary outcome

Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4
Time frame: Baseline to Week 4

Results and safety

Results posted to the registry on 3 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	30	29
Cohort 2	29	28

Primary outcome: Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4

Time frame: Baseline to Week 4. Least squares mean (90% Confidence Interval). Unit: mmHg

Measure	Placebo n = 58	Lorundrostat n = 58
Value	-1.755 (-4.966 to 1.455)	-9.253 (-12.453 to -6.053)

Adverse events

Time frame: All adverse events (AEs) and serious adverse events (SAEs) will be collected from signing of the ICF to end of follow up.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 57 (0%)	18 of 57 (31.6%)	0 of 57
Lorundrostat	2 of 58 (3.4%)	29 of 58 (50%)	0 of 58

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42778148Weir MR, Bhaduri S, Lee K, Galvez O, Kooienga L, Kopjar B, Novin M, Rodman D; Explore-CKD Trial Group. Results from the Phase 2 Explore-CKD Trial of lorundrostat, a novel aldosterone synthase inhibitor, in participants with uncontrolled hypertension, chronic kidney disease, and albuminuria. Kidney Int. 2026 Sep 23:S0085-2538(26)00808-2. doi: 10.1016/j.kint.2026.08.021. Online ahead of print.
Derived from this study: PubMed 41805697Hu 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Chronic Kidney Disease, run by Mineralys Therapeutics Inc. at 44 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?

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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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. 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?

Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) Systolic Blood Pressure (SBP) at Week 4 (time frame: Baseline to Week 4). 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 NCT06150924, which also lists 2 linked publications.

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 3 Jun 2026.