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 up to 36 or 48-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 can remain on study until marketing authorization
or early termination of the trial by the sponsor.
