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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

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

Key facts

Study ID: NCT05968430
Run by: Mineralys Therapeutics Inc.
People needed: 1076
Starts: 2023-07-14
Expected to finish: 2027-05-01
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent signed by the participant, obtained before any study-related assessment is performed
At least 18 years of age at the time of signing the informed consent form (ICF)
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
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
Willing and able to comply with the study instructions and attend all scheduled study visits
[Randomized treatment withdrawal substudy only]
Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

You may not qualify if…

Women who are pregnant, plan to become pregnant, or are breast-feeding
Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
In the opinion of the Investigator, any condition that will preclude participation in the study
[Randomized treatment withdrawal substudy only]
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

Where it is running

G & L Research LLC — Foley, Alabama, United States
Chandler Clinical Trials — Chandler, Arizona, United States
Arizona Kidney — Glendale, Arizona, United States
AKDHC Medical Research Services, AZ — Phoenix, Arizona, United States
Noble Clinical Research — Tucson, Arizona, United States
Del Sol Research Management, LLC — Tucson, Arizona, United States
Entertainment Medical Group, Inc — Beverly Hills, California, United States
CA Institute of Renal Research, CA — Chula Vista, California, United States
Amicis Research Center - Vacaville — Fairfield, California, United States
Amicis Research Center - Granada Hills — Granada Hills, California, United States
Marvel Clinical Research 002, LLC — Huntington Beach, California, United States
University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
Clinical Trials Research (CTR) - Lincoln — Lincoln, California, United States
Boston Clinical Trials — Boston, Massachusetts, United States
Academic Medical Research Institute (AMRI) - Los Angeles — Los Angeles, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
Amicis Research Center - Mission Hills — Northridge, California, United States
Amicis Research Center-Northridge — Northridge, California, United States
Northridge Clinical Trials — Northridge, California, United States
Pasadena Clinical Trials — Pasadena, California, United States
Empire Clinical Research — Pomona, California, United States
Clinical Trials Research (CTR) - Sacramento — Sacramento, California, United States
Triwest Research Associates — San Diego, California, United States
San Jose Clinical Trials — San Jose, California, United States
Accel Research Sites (ARS) - Birmingham Clinical Research Unit — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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