NCT05769608

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Mineralys Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.

Detailed description

This study is a Phase 2 trial to evaluate the blood pressure-lowering effects of lorundrostat (an ASI), administered as add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension. The study consists of a standardized AHT regimen run-in period followed by a randomized, double-blind, placebo-controlled, parallel arm period. Following the double-blind period subjects may be offered the opportunity to participate in an open-label extension (OLE) study. Subjects electing to not participate in the OLE will undergo an end of study (EoS) visit approximately 2 weeks after the last dose of study drug to complete their participation in the study.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Placebo once daily for 12 weeks
DRUG	lorundrostat Dose 1	lorundrostat Dose 1 once daily for 12 weeks
DRUG	lorundrostat Dose 2	lorundrostat Dose 1 once daily for 4 weeks then lorundrostat Dose 2 once daily for 8 weeks for subjects who meet prespecified criteria

Timeline

• Start date: 2023-03-13
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2023-03-15
• Last updated: 2026-01-20

Locations

104 sites across 1 country: United States

Regulatory

• FDA-regulated drug study