Active — Not RecruitingPhase 3

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

United States1,076 participantsStarted 2023-07-14

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

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
✕. 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

What they're measuring

Change from MLS-101-301 baseline automated office blood pressure

Timeframe: Week 36

Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW

Timeframe: Week 16

Trial details

NCT IDNCT05968430

SponsorMineralys Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

View on ClinicalTrials.gov More Hypertension trials