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Clinical Trials in the UK / NCT05968430
Active, not recruiting Phase 3

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

NCT05968430 · tracked via the Priya Life Science UK tracker
Sponsor
Mineralys Therapeutics Inc.
Phase
Phase 3
Started
2023-07-14
Last updated
2026-09-11

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

lorundrostatPlacebo

lorundrostat: Tablet, administered orally

Placebo: Tablet, administered orally

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 (ICF) 3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol 4. 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 5. Willing and able to comply with the study instructions and attend all scheduled study visits \[Randomized treatment withdrawal substudy only\] 6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed Exclusion Criteria: 1. Women who are pregnant, plan to become pregnant, or are breast-feeding 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol 3. In the opinion of the Investigator, any condition that will preclude participation in the study \[Randomized treatment withdrawal substudy only\] 4. Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901

Primary outcome measure(s)

Trial sites (177)

FacilityCityRegionStatus
Accel Research Sites (ARS) - Birmingham Clinical Research Unit Birmingham Alabama
G & L Research LLC Foley Alabama
Chandler Clinical Trials Chandler Arizona
Arizona Kidney Glendale Arizona
AKDHC Medical Research Services, AZ Phoenix Arizona
Noble Clinical Research Tucson Arizona
Del Sol Research Management, LLC Tucson Arizona
Entertainment Medical Group, Inc Beverly Hills California
CA Institute of Renal Research, CA Chula Vista California
Amicis Research Center - Vacaville Fairfield California
Amicis Research Center - Granada Hills Granada Hills California
Marvel Clinical Research 002, LLC Huntington Beach California
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) La Jolla California
Clinical Trials Research (CTR) - Lincoln Lincoln California
Academic Medical Research Institute (AMRI) - Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Amicis Research Center - Mission Hills Northridge California
Amicis Research Center-Northridge Northridge California
Northridge Clinical Trials Northridge California
Pasadena Clinical Trials Pasadena California
Empire Clinical Research Pomona California
Clinical Trials Research (CTR) - Sacramento Sacramento California
Triwest Research Associates San Diego California
San Jose Clinical Trials San Jose California
Amicis Research Center - Valencia Valencia California
Kidney & Hypertension Center - Victorville Victorville California
Blue Coast Research Center (BCRC) Vista California
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research) Vista California
Colorado Kidney (Denver) Nephrology Denver Colorado
CMR of Greater New Haven Hamden Connecticut
Qway Research Hialeah Florida
Indago Research and Health Center Hialeah Florida
Clinical Neuroscience Solutions, Inc Jacksonville Florida
Nuovida Research Center Corp Miami Florida
Clinical Neuroscience Solutions, Inc Orlando Florida
Nephrology Associates of Central Florida Orlando Florida
AES - Orlando Orlando Florida
Pines Care Research Center Pembroke Pines Florida
Patron Medical - Andres Patron D.O. (Patron Ventures, LLC) Pembroke Pines Florida
Progressive Medical Research Port Orange Florida

+ 137 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05968430 on ClinicalTrials.gov ↗ ← All trials in the UK