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NCT05968430 Clinical Trial

Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension

Hypertension Clinical Trial

Official title:
An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05968430
Other study ID # MLS-101-901
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 14, 2023
Est. completion date December 2025

Study information
Verified date June 2024
Source Mineralys Therapeutics Inc.
Contact Shannon Spires
Phone 905-626-1111
Email sspires@mineralystx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.

Description:

This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension. The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree to transition immediately to this open-label extension (OLE) study (ie, will not participate in the end of study observation period of the parent study). The study will be conducted at approximately 200 centers.

Recruitment information / eligibility
Status Recruiting
Enrollment 900
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Written informed consent signed by the participant, obtained before any study-related assessment is performed 2. At least 18 years of age at the time of signing the informed consent form Participation in a lorundrostat study with the option of transitioning to the OLE study 3. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug 4. Willing and able to comply with the study instructions and attend all scheduled study visits 5. [Randomized treatment withdrawal only] A minimum of 75% and a maximum of 125% compliance with lorundrostat from Week 32 to Week 48 of the OLE 6. [Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least 25 mg once daily Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant, or are breast-feeding 2. In the opinion of the principal investigator, any other condition that will preclude participation in the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lorundrostat
lorundrostat once daily for 48 weeks
• lorundrostat
lorundrostat once daily for 4 weeks
• Placebo
Placebo once daily for 4 weeks

Locations
Country Name City State
Puerto Rico Latin Clinical Trial Center San Juan
United States Albany Medical College Albany New York
United States Triad Internal Medicine Asheboro North Carolina
United States Accel Research Sites (ARS) - Birmingham Clinical Research Unit Birmingham Alabama
United States Erie County Medical Center Buffalo New York
United States Burke Internal Medicine Burke Virginia
United States Diabetes & Endocrinology Associates of Stark County Canton Ohio
United States Punzi Medical Center Carrollton Texas
United States Cleveland Clinic - Main Campus Cleveland Ohio
United States Accel Research Sites Decatur Georgia
United States Willamette Valley Clinical Studies Eugene Oregon
United States AES Evansville/Synexus Clinical Research Evansville Indiana
United States CMR of Greater New Haven Hamden Connecticut
United States Indago Research and Health Center Hialeah Florida
United States Juno Research, LLC Houston Texas
United States Synergy Groups Medical - Bissonet Site Houston Texas
United States Marvel Clinical Research 002, LLC Huntington Beach California
United States Clinical Neuroscience Solutions, Inc Jacksonville Florida
United States Georgia Clinical Research, LLC Lawrenceville Georgia
United States The Research Group of Lexington, LLC Lexington Kentucky
United States Clinical Trials Research (CTR) - Lincoln Lincoln California
United States Lifedoc Research Memphis Tennessee
United States ActiveMed Practices & Research LLC Methuen Massachusetts
United States Nuovida Research Center Corp Miami Florida
United States Synergy Groups Medical - Missouri City Missouri City Texas
United States Vanderbilt University Medical Center (VUMC) Nashville Tennessee
United States Lucas Research New Bern North Carolina
United States Eastern VA Medical School Norfolk Virginia
United States Coastal Carolina Research Center North Charleston South Carolina
United States AES - Orlando Orlando Florida
United States Clinical Neuroscience Solutions, Inc Orlando Florida
United States Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) Pembroke Pines Florida
United States Clinical Investigations of Texas (CIT) Plano Texas
United States Empire Clinical Research Pomona California
United States Progressive Medical Research Port Orange Florida
United States Sun Research Institute (SRI) - San Antonio San Antonio Texas
United States Triwest Research Associates San Diego California
United States Clinical Research of West Florida, Inc. Tampa Florida
United States Del Sol Research Management, LLC Tucson Arizona
United States Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research Vandalia Ohio
United States Blue Coast Research Center (BCRC) Vista California

Sponsors (1)
Lead Sponsor Collaborator
Mineralys Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in automated office blood pressure (AOBP) systolic blood pressure (SBP) Week 16 to Week 48
Secondary Change in AOBP SBP in subjects taking lorundrostat at study entry Week 0 - 48
Secondary Change in AOBP SBP in subjects taking placebo at study entry Week 16 - 48
Secondary Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry Week 0 - 48
Secondary Change in AOBP DBP in subjects taking placebo at study entry Week 16 - 48
Secondary Proportion of subjects with AOBP SBP =130 mmHg at each visit Through study completion, up to 54 weeks
Secondary Proportion of subjects with AOBP =130/80 mmHg at each visit Through study completion, up to 54 weeks
Secondary In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP Week 48 to Week 52
Secondary In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP Week 48 to Week 52
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