NCT05968430

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,076 (actual)
• Sponsor: Mineralys Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	lorundrostat	Tablet, administered orally
DRUG	Placebo	Tablet, administered orally

Timeline

• Start date: 2023-07-14
• Primary completion: 2025-12-30
• Completion: 2026-12-01
• First posted: 2023-08-01
• Last updated: 2026-02-17

Locations

177 sites across 13 countries: United States, Australia, Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study