NCT06153693

Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled and Resistant Hypertension

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,083 (actual)
• Sponsor: Mineralys Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Detailed description

This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications, one of which must be a thiazide or thiazide-like diuretic. The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study. Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo once daily (QD) for 12 weeks
DRUG	lorundrostat Dose 1	50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
DRUG	lorundrostat Dose 2	50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria

Timeline

• Start date: 2023-11-22
• Primary completion: 2024-12-10
• Completion: 2025-01-24
• First posted: 2023-12-01
• Last updated: 2025-12-11

Locations

184 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