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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea, Hypertension

In brief

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.

Key facts

Study ID

NCT06785454

Run by

Mineralys Therapeutics Inc.

People needed

48

Starts

2025-02-28

Expected to finish

2025-12-29

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m\^2)
• Previously diagnosed with moderate-to-severe OSA
• AHI ≥15 events per hour (/hr) prior to Randomization
• AOBP SBP of ≥130 and less than or equal to (≤) 180 millimeter of mercury (mmHg) and AOBP diastolic blood pressure (DBP) ≥60 and ≤110 mmHg
• Participants on CPAP or PAP therapy are eligible provided they are on PAP for ≥4 hours per night (documented) and for at least 3 months prior to the study enrollment (documented)
• Participants not currently on PAP therapy, and not anticipated to start PAP for the duration of the study
• Fertile male and female participants of childbearing potential, and their partners, must agree to use protocol-defined methods of highly effective contraception from the Screening Visit until 28 days after the last dose of study drug

You may not qualify if…

• Type 2 diabetes mellitus (T2DM) with a glycosylated hemoglobin (HbA1c) greater than (>) 9 percent (%) (>74.9 millimoles per mol [mmol/mol]) at the Screening Visit or history of diabetic ketoacidosis in the 6 months prior to the Screening Visit
• Participants on a glucagon-like peptide-1 (GLP-1) agonist.
• Any surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy within 3 months prior to Screening, or planned during participation in the study or within 1 month of the last study visit.
• Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
• Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
• Use of bilevel positive airway pressure (BiPAP) therapy.
• eGFR less than (<) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at Screening using serum creatinine or cystatin-C
• History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness
• Diagnosed with Child-Pugh Class C
• Participants who regularly use caffeine stimulants or participants who are unwilling to reduce intake to 300 mg per day (approximately 3 cups of coffee), for a period of at least 3 days prior to the Screening visit or a sleep study
• Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit
• Requirement for nocturnal use of supplemental oxygen
• Women who are pregnant, plan to become pregnant, or are breastfeeding
• Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
• Previously diagnosed, recurrent orthostatic hypotension
• Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.

Where it is running

• The University of Alabama — Tuscaloosa, Alabama, United States
• Chandler Clinical Trials — Chandler, Arizona, United States
• Preferred Research Partners Inc. — Little Rock, Arkansas, United States
• Orange County Research Institute — Anaheim, California, United States
• The Neurology Center of Southern California - Profound Research, LLC — Carlsbad, California, United States
• Probe Clinical Research Corporation — Riverside, California, United States
• Research Carolina Elite — Denver, Colorado, United States
• Nouvelle Clinical Research — Cutler Bay, Florida, United States
• Arrow Clinical Trials — Daytona Beach, Florida, United States
• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States
• CNS Healthcare - Orlando (Clinical Neuroscience Solutions) — Orlando, Florida, United States
• NeuroTrials Research Inc — Atlanta, Georgia, United States
• Centricity Research Rincon Pulmonology — Rincon, Georgia, United States
• Chicago Research Center Inc — Chicago, Illinois, United States
• Centennial Medical Group — Columbia, Maryland, United States
• Velocity Clinical Research, Rockville — Rockville, Maryland, United States
• Henry Ford Health System/Henry Ford Medical Center - Columbus — Novi, Michigan, United States
• Revive Research Institute, Inc — Southfield, Michigan, United States
• Healthcare Research Network — Hazelwood, Missouri, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Patient First MD — Middletown, New Jersey, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Northwest Research Center — Portland, Oregon, United States
• CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis) — Memphis, Tennessee, United States
• Huntsville Research Institute LLC — Huntsville, Texas, United States

Full record on ClinicalTrials.gov

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