Status:
ACTIVE_NOT_RECRUITING
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Lead Sponsor:
Mineralys Therapeutics Inc.
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
Detailed Description
The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension. This study consists of an o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT05968430
Start Date
July 14 2023
End Date
December 1 2026
Last Update
June 15 2025
Active Locations (175)
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1
Accel Research Sites (ARS) - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
2
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Foley, Alabama, United States, 36535
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Chandler, Arizona, United States, 85224
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