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

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 open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.

A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.

Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.