NCT06785454

A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension

A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mineralys Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to assess the effect of lorundrostat taken orally (po) once a day on the Apnea-Hypopnea Index (AHI) in participants with moderate to severe obstructive sleep apnea (OSA) and hypertension.

Detailed description

The study is a randomized, double-blind (DB), placebo controlled, crossover study. A 4-week screening period is followed by two DB 4-week treatment periods separated by a 2-week washout period. Participants must be 18 to 75 years old with moderate to severe OSA, hypertension and meet all applicable eligibility criteria. Participants who are medically prescribed and deemed compliant with positive airway pressure (PAP) therapy for greater than or equal to (\>=) 4 hours per night (Continuous PAP \[CPAP\], or automatic PAP \[autoPAP\]) and for at least 3 months prior to the study enrollment are eligible for the study. Participants on PAP therapy should comply with PAP therapy for the duration of the study. Participants who are not currently on PAP therapy and not anticipated to start PAP for the duration of the study, are also eligible for the study.

Conditions

• Obstructive Sleep Apnea
• Hypertension

Interventions

Type	Name	Description
DRUG	Lorundrostat	Lorundrostat tablet.
DRUG	Placebo	Lorundrostat matching placebo tablet.

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-12-17
• Completion: 2025-12-29
• First posted: 2025-01-21
• Last updated: 2026-01-13

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study