A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep … (NCT06785454) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
United States48 participantsStarted 2025-02-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Placebo-adjusted Change From Baseline in AHI at Week 4
✕. 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