Who is eligible for clinical trial NCT05968430?

Participants must meet protocol criteria for Hypertension. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05968430 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-22

Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension (NCT05968430)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Mineralys Therapeutics Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (5 items).

Location: Accel Research Sites (ARS) - Birmingham Clinical Research Unit — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (177 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗