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

Last updated: February 19, 2025
Sponsor: Mineralys Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Renal Failure

Stress

Circulation Disorders

Treatment

Part A - Lorundrostat QD + Dapaglifozin QD

Placebo QD + SGLT2i QD, Washout, Lorundrostat 25mg+SGLT2i QD

Part B - Lorundrostat QD Open Label

Clinical Study ID

NCT06150924
MLS-101-206
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion

Major Exclusion Criteria:

  1. Subjects with known hypersensitivity to lorundrostat or any of its respectiveexcipients

  2. Subjects with known hypersensitivity to dapagliflozin or any of its respectiveexcipients (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 receptorantagonist (MRAs), including, but not limited to amiloride, triamterene,spironolactone, eplerenone, finerenone, from 4 weeks prior to the Screening Visitand 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 otherknown 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) oranticipated need for immunosuppressive therapy

  9. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >10% (>86 mmol/mol) atScreening

Study Design

Total Participants: 60
Treatment Group(s): 5
Primary Treatment: Part A - Lorundrostat QD + Dapaglifozin QD
Phase: 2
Study Start date:
December 14, 2023
Estimated Completion Date:
May 31, 2025

Study 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).

Connect with a study center

  • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista

    Chula Vista, California 91910
    United States

    Site Not Available

  • Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro

    El Centro, California 92243
    United States

    Site Not Available

  • Amicis Research Center - Granada Hills

    Granada Hills, California 91344
    United States

    Site Not Available

  • Balboa Nephrology Medical Group, Inc. (Bnmg) - La Mesa

    La Mesa, California 91942-3059
    United States

    Site Not Available

  • Academic Medical Research Institute (AMRI) - Los Angeles

    Los Angeles, California 90022
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Site Not Available

  • Amicis Research Center - Vacaville

    Vacaville, California 95687-3560
    United States

    Site Not Available

  • Colorado Kidney Care (Denver Nephrology) - Denver Office

    Denver, Colorado 80218-1216
    United States

    Site Not Available

  • Qway Research

    Coconut Grove, Florida 33133
    United States

    Site Not Available

  • Indago Research and Health Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Elixia Pines, LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Elixia Central Florida, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • Infigo Clinical Research, Llc

    Sanford, Florida 32771
    United States

    Site Not Available

  • Genesis Clinical Research - Tampa

    Tampa, Florida 33614
    United States

    Site Not Available

  • Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • American Clinical Trials Llc

    Acworth, Georgia 30101
    United States

    Site Not Available

  • Nephrology of the Golden Isles - Brunswick

    Brunswick, Georgia 31520
    United States

    Site Not Available

  • ClinCept, LLC

    Columbus, Georgia 32896
    United States

    Site Not Available

  • Georgia Nephrology, Llc

    Lawrenceville, Georgia 30046-8761
    United States

    Site Not Available

  • Nephrology Associates of Kentuckiana, PSC (NAK)

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Lcms Health University Medical Center New Orleans

    New Orleans, Louisiana 70112-3018
    United States

    Site Not Available

  • Northwest Louisiana Nephrology, Llc - Shreveport

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center)

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Elixia MKC, LLC

    Pontiac, Michigan 48341
    United States

    Site Not Available

  • Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Seacoast Kidney & Hypertension Specialists - Portsmouth Office

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Suny Downstate Medical Center - Parkside Dialysis Center

    Brooklyn, New York 11226-1508
    United States

    Site Not Available

  • Nephrology Associates

    Fresh Meadows, New York 11365
    United States

    Site Not Available

  • Nephrology Associates, PC

    Fresh Meadows, New York 11365
    United States

    Site Not Available

  • Triad Internal Medicine

    Asheboro, North Carolina 27205
    United States

    Site Not Available

  • Nephrology Associates, Pllc - Winston-Salem

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Nephrology Associates, Pllc - Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Nephrology Consultants - Oklahoma City

    Oklahoma City, Oklahoma 73116-1516
    United States

    Site Not Available

  • Columbia Nephrology

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Southeast Renal Research Institute

    Chattanooga, Tennessee 37408
    United States

    Site Not Available

  • Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri)

    Dallas, Texas 75235
    United States

    Site Not Available

  • Liberty Research Center

    Dallas, Texas 75237
    United States

    Site Not Available

  • R&H Clinical Research

    Katy, Texas 27205
    United States

    Site Not Available

  • E T Nephrology Associates - Lufkin

    Lufkin, Texas 75904
    United States

    Site Not Available

  • Prx Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Gamma Medical Research, Inc

    Mission, Texas 78572
    United States

    Site Not Available

  • Chrysalis Clinical Research (CCR)

    Saint George, Utah 84790
    United States

    Site Not Available

  • Mendez Center for Clinical Research, LLC

    Woodbridge, Virginia 22191
    United States

    Site Not Available

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