Mineralys 901
Research type
Research Study
Full title
An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension
IRAS ID
1008309
Contact name
Jeffery Fellows
Contact email
Sponsor organisation
Mineralys Therapeutics, Inc
Clinicaltrials.gov Identifier
Research summary
Lorundrostat blocks the production of aldosterone, which is a hormone that can increase blood pressure when its levels are high. Lorundrostat is an investigational (experimental) drug that has been studied in previous clinical studies which suggest it might be a potential treatment for people with hypertension.
Participants who received lorundrostat in a previous clinical study will be invited to participate in this open-label extension study. The purpose of this study is to assess the blood pressure lowering effect of lorundrostat, in combination with approved medications used for treating high blood pressure, and to determine if lorundrostat is well-tolerated over a long-term period in people with hypertension.
Approximately 1400 participants will take part in this study at approximately 250 centres globally.
The total duration for each study participant in the study will be approximately 9.5 months with approximately 6–7 visits to the study centre. This study has 2 main periods:
1. An open-label treatment period of 36 weeks or 48 weeks for some US participants
2. A Follow-up period of 2 weeks
Participants will take 1 tablet of lorundrostat by mouth once daily at approximately the same time each morning. The starting dose of lorundrostat will be 50mg (if they had a permanent dose reduction in the previous study, they will start on 25mg once daily).Some participants may be invited to take part in a 4-week randomised, double-blind, placebo-controlled, treatment withdrawal sub study at Week 12 if eligible. They will randomly be assigned to receive daily doses of either placebo (dummy drug) or lorundrostat (maintained at the same dose they were taking at Week 12) for 4 weeks. At the end of the 4 weeks, they will resume lorundrostat at the same dose they were taking at Week 12.
Participants will complete several tests and assessments during these visits including physical examinations, ECGs, blood tests, urine tests and blood pressure measurements.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0311
Date of REC Opinion
11 Jun 2024
REC opinion
Further Information Favourable Opinion