This study is accepting new patients by invitation only

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

Eligibility: for people ages 18 years and up (full criteria)
Location: at La Jolla, California and other locations
Dates: study started July 2023
completion around December 2026

Description

Summary

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

Official Title

An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension

Details

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.

Keywords

Hypertension, Blood pressure, Uncontrolled hypertension, Hypertensive, lorundrostat, RTW Substudy

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla California 92037 United States
Triwest Research Associates
San Diego California 92108 United States
CA Institute of Renal Research, CA
Chula Vista California 91910 United States
Blue Coast Research Center (BCRC)
Vista California 92081 United States
Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
Vista California 92083 United States

Details

Status: accepting new patients by invitation only
Start Date: July 2023
Completion Date: December 2026 (estimated)
Sponsor: Mineralys Therapeutics Inc.
ID: NCT05968430
Phase: Phase 3 High Blood Pressure Research Study
Study Type: Interventional
Participants: Expecting 1400 study participants
Last Updated: March 11, 2025