A Phase 2 interventional study of Lorundrostat and Placebo in Obstructive Sleep Apnea and Hypertension, sponsored by Mineralys Therapeutics Inc.. Completed at 27 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Mineralys Therapeutics Inc. · Phase 2, Interventional, and Treatment
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.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 48 is close to the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Mineralys Therapeutics Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lorundrostat · Drug: Placebo
Drug: Lorundrostat · Drug: Placebo
Lorundrostat tablet.
Lorundrostat matching placebo tablet.
Placebo-adjusted Change From Baseline in AHI at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4
Time frame: Baseline, Week 4
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Mineralys Therapeutics Inc.