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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150924
Other study ID # MLS-101-206
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 14, 2023
Est. completion date January 2025

Study information

Verified date March 2024
Source Mineralys Therapeutics Inc.
Contact Maghan McCormick
Phone 1-888-378-6240
Email mmcormick@mineralystx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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).
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.

Locations

Country Name City State
United States Triad Internal Medicine Asheboro North Carolina
United States Tufts University School of Medicine (Tusm) - Tufts Medical Center (Tmc) (Tufts-New England Medical Center) Boston Massachusetts
United States Nephrology of the Golden Isles - Brunswick Brunswick Georgia
United States Southeast Renal Research Institute Chattanooga Tennessee
United States Balboa Nephrology Medical Group, Inc. (BNMG) - California Institute of Renal Research (CIRR) - Chula Vista Chula Vista California
United States Qway Research Coconut Grove Florida
United States ClinCept, LLC Columbus Georgia
United States Dallas Nephrology Associates (Dna) - Renal Disease Research Institute (Rdri) Dallas Texas
United States Balboa Nephrology Medical Group, Inc. (BNMG) - El Centro El Centro California
United States Nephrology Associates Fresh Meadows New York
United States Nephrology Associates, PC Fresh Meadows New York
United States Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thunderbird Office Glendale Arizona
United States Elixia Pines, LLC Hollywood Florida
United States Kansas City Kidney Consultants (Arms, Dodge, Robinson, Wilber & Crouch, Inc.) - Kansas City Kansas City Missouri
United States R&H Clinical Research Katy Texas
United States Academic Medical Research Institute (AMRI) - Los Angeles Los Angeles California
United States Nephrology Associates of Kentuckiana, PSC (NAK) Louisville Kentucky
United States E T Nephrology Associates - Lufkin Lufkin Texas
United States Gamma Medical Research, Inc Mission Texas
United States Elixia Central Florida, LLC Orlando Florida
United States Arizona Kidney Disease & Hypertension Centers (AKDHC) - Thomas Office Phoenix Arizona
United States Elixia MKC, LLC Pontiac Michigan
United States Seacoast Kidney & Hypertension Specialists - Portsmouth Office Portsmouth New Hampshire
United States Chrysalis Clinical Research (CCR) Saint George Utah
United States Northwest Louisiana Nephrology, Llc - Shreveport Shreveport Louisiana
United States Genesis Clinical Research - Tampa Tampa Florida
United States Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office West Palm Beach Florida
United States Nephrology Associates, Pllc - Winston-Salem Winston-Salem North Carolina
United States Mendez Center for Clinical Research, LLC Woodbridge Virginia

Sponsors (1)

Lead Sponsor Collaborator
Mineralys Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Change from baseline in automated office blood pressure (AOBP) SBP at Week 8 baseline to Week 8
Primary Part B: Incidence and severity of AEs baseline to Week 8
Secondary Part A: Change from Week 12 in AOBP SBP at Week 20 Week 12 to Week 20
Secondary Part A: Percent change from baseline in 24-hour urine albumin to creatinine ratio (UACR) at Week 8 baseline to Week 8
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