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

a study on High Blood Pressure

Summary

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

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 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.

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Written informed consent signed by the participant, obtained before any study-related assessment is performed
  2. At least 18 years of age at the time of signing the informed consent form (ICF)
  3. 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
  4. 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

  5. Willing and able to comply with the study instructions and attend all scheduled study visits

    [Randomized treatment withdrawal substudy only]

  6. 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...

  1. Women who are pregnant, plan to become pregnant, or are breast-feeding
  2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol

  3. In the opinion of the Investigator, any condition that will preclude participation in the study

    [Randomized treatment withdrawal substudy only]

  4. 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) accepting new patients
    La Jolla California 92037 United States
  • Triwest Research Associates accepting new patients
    San Diego California 92108 United States
  • Blue Coast Research Center (BCRC) accepting new patients
    Vista California 92081 United States

Details

Status
accepting new patients
Start Date
Completion Date
(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
Contact us about this trial