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Completed NCT06785454

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

Conditions: Obstructive Sleep Apnea, Hypertension

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 48
Sponsor: Mineralys Therapeutics Inc.

Location: The University of Alabama Tuscaloosa Alabama

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.

Eligibility Criteria

Inclusion Criteria: 1. Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m\^2) 2. Previously diagnosed with moderate-to-severe OSA 3. AHI ≥15 events per hour (/hr) prior to Randomization 4. 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 5. 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) 6. Participants not currently on PAP therapy, and not anticipated to start PAP for the duration of the study 7. 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 Exclusion Criteria: 1. 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 2. Participants on a glucagon-like peptide-1 (GLP-1) agonist. 3. 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. 4. Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration 5. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia 6. Use of bilevel positive airway pressure (BiPAP) therapy. 7. eGFR less than (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06785454). StuddyBuddy aggregates publicly available trial information.