Mineralys 301
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension
IRAS ID
1008308
Contact name
Jeffery Fellows
Contact email
Sponsor organisation
Mineralys Therapeutics, Inc
ISRCTN Number
not applicable
Research summary
We are evaluating a new medication called lorundrostat™ in patients with high blood pressure. Lorundrostat blocks the production of aldosterone, which is a hormone that increases blood pressure when its levels are high. Lorundrostat is an investigational (experimental) medicine and has been studied in previous clinical trials which suggest it might be a potential treatment for people with uncontrolled and resistant hypertension.
The purpose of this study is to assess the blood pressure lowering effect of lorundrostat, in combination with prescribed medications, one of which should be a thiazide or thiazide-like diuretic, used for treating high blood pressure. We will evaluate how long the medicine stays detectable in the body and how it may affect other disease markers. Approximately 1000 participants with uncontrolled or resistant hypertension that is not well controlled with their current medications will take part in this study at approximately 200-250 centers globally.
The total duration for each study participant in the study will be 18 weeks with approximately 8-9 study visits. These include a screening period of up to 2 weeks, a run-in period of 2 weeks, a randomised treatment period of 12 weeks and an end of study visit of 2 weeks after last treatment dose. Participants will complete several tests and assessments during these visits including physical examinations, ECGs, blood tests, urine tests and blood pressure measurements
Participants will be randomly assigned (like flipping a coin) to receive tablets containing either lorundrostat or placebo (dummy drug) to be taken once daily in addition to their prescribed antihypertensive (AHT) medications used for treating high blood pressure.
Participants may be asked to take part in an open-label extension study after the 12-week treatment phase. If they take part in the open-label extension their participation in this study will be 16 weeks.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0995
Date of REC Opinion
24 Jan 2024
REC opinion
Further Information Favourable Opinion