Efficacy and Safety of Lorundrostat Alone, and in Combination With Dapagliflozin in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria

March 8, 2024 updated by: Mineralys Therapeutics Inc.

A Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat Alone, and Lorundrostat in Combination With Dapagliflozin, in Adults With Hypertension and Chronic Kidney Disease With Albuminuria

This is a 2-part study evaluating the efficacy and safety of lorundrostat (an aldosterone synthase inhibitor [ASI]) 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) either in combination with dapagliflozin, or alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Part A is a double-blind, placebo-controlled, parallel arm study. Part A consists of up to a 2-week Screening period, followed by two 8-week treatment periods (Period 1 and Period 2) separated by a 4-week single-blind washout phase. Part B consists of up to a 2-week Screening period, followed by an open-label, single arm, dose escalation 8-week treatment phase.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • 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 Backup

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office
        • Contact:
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office
        • Contact:
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista
        • Contact:
      • El Centro, California, United States, 92243
        • Recruiting
        • Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro
        • Contact:
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Academic Medical Research Institute (AMRI) - Los Angeles
        • Contact:
    • Florida
      • Coconut Grove, Florida, United States, 33133
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Elixia Pines, LLC
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Elixia Central Florida, LLC
        • Contact:
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Genesis Clinical Research - Tampa
        • Contact:
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office
        • Contact:
    • Georgia
      • Columbus, Georgia, United States, 32896
        • Recruiting
        • ClinCept, LLC
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Nephrology Associates of Kentuckiana, PSC (NAK)
        • Contact:
    • Michigan
      • Pontiac, Michigan, United States, 48341
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City
        • Contact:
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • Seacoast Kidney & Hypertension Specialists - Portsmouth Office
        • Contact:
    • New York
      • Fresh Meadows, New York, United States, 11365
        • Recruiting
        • Nephrology Associates
        • Contact:
      • Fresh Meadows, New York, United States, 11365
        • Recruiting
        • Nephrology Associates, PC
        • Contact:
    • North Carolina
      • Asheboro, North Carolina, United States, 27205
        • Recruiting
        • Triad Internal Medicine
        • Contact:
    • Texas
      • Katy, Texas, United States, 27205
      • Lufkin, Texas, United States, 75904
        • Recruiting
        • E T Nephrology Associates - Lufkin
        • Contact:
      • Mission, Texas, United States, 78572
        • Recruiting
        • Gamma Medical Research, Inc
        • Contact:
    • Utah
      • Saint George, Utah, United States, 84790
        • Recruiting
        • Chrysalis Clinical Research (CCR)
        • Contact:
    • Virginia
      • Woodbridge, Virginia, United States, 22191
        • Recruiting
        • Mendez Center for Clinical Research, LLC
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Major Inclusion Criteria:

  1. At Screening, UACR of 300-3500 mg/g, inclusive

  2. At Screening, eGFRs of:

    Part A: ≥45 and <90 mL/min/1.73 m2 Part B: ≥30 and <45 mL/min/1.73 m2

  3. At Screening, AOBP SBP of 135-180 mmHg, inclusive
  4. AOBP SBP of 135-160 mmHg, inclusive, at Randomization (Part A) or Week 0 visit (Part B)
  5. On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
  6. At Screening, body mass index (BMI) of 18-45 kg/m2, inclusive

Major Exclusion Criteria:

Part A only:

  1. Subjects with known hypersensitivity to dapagliflozin or any of its respective excipients
  2. Previous treatment with dapagliflozin or other sodium-glucose cotransporter 2 inhibitor (SGLT2i) within 4 weeks prior to the Screening Visit

Part A and Part B:

  1. Diabetes mellitus with a glycosylated hemoglobin (HbA1c) >9% (>74.9 mmol/mol) at Screening
  2. Medical history of active autoimmune disease or recent or anticipated need for immunosuppressive therapy
  3. 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
  4. Medical history of advanced liver disease, including cirrhosis
  5. History of adrenal insufficiency or an abnormal ACTH stimulation test within 1 year prior to Screening
  6. Use of epithelial sodium channel (ENaC) inhibitors or mineralocorticoid receptor antagonists (MRAs), including but not limited to amiloride, triamterene, spironolactone, eplerenone or finerenone from 4 weeks prior to the Screening Visit and during study participation. With exception of MRAs in primary aldosteronism.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A - Cohort 1
Drug: Part A - Lorundrostat QD + Dapaglifozin QD
8 weeks of treatment with lorundrostat QD (Dose 1) plus dapaglifozin QD, 4 weeks of placebo QD washout, followed by 8 weeks of treatment with placebo QD.
Experimental: Part A - Cohort 2
Drug: Part A - Lorundrostat QD
8 weeks of treatment with placebo QD, 4 weeks of placebo QD washout, followed by 8 weeks of treatment with lorundrostat QD (Dose 1).
Experimental: Part B - Open Label
Drug: Part B - Lorundrostat QD Open Label
4 weeks of treatment with lorundrostat QD (Dose 2) followed by 4 weeks of treatment with lorundrostat QD (Dose 3) for subjects who meet prespecified criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Change from baseline in automated office blood pressure (AOBP) SBP at Week 8
Time Frame: baseline to Week 8
baseline to Week 8
Part B: Incidence and severity of AEs
Time Frame: baseline to Week 8
baseline to Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Mineralys Therapeutics Inc.

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)

December 14, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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