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

Launched by MINERALYS THERAPEUTICS INC. · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called lorundrostat to see how well it works and how safe it is for people who have both obstructive sleep apnea (OSA) and high blood pressure (hypertension). The main goal is to find out if taking lorundrostat once a day can reduce the number of breathing interruptions people experience during sleep, which is measured by something called the Apnea-Hypopnea Index (AHI). This study is for adults aged 27 to 74 who have been diagnosed with moderate to severe OSA and have specific blood pressure readings.

To participate in the trial, individuals need to be overweight (with a body mass index of 27 or higher) and have a history of moderate to severe OSA. They must also have a certain level of breathing interruptions (at least 15 events per hour) and high blood pressure within specific limits. Participants who are already using continuous positive airway pressure (CPAP) therapy for their sleep apnea are welcome, as long as they have been using it regularly for at least three months. It's important to note that this trial is not yet recruiting participants, but once it starts, those who qualify can expect to take the study medication daily and undergo monitoring to assess their health and the treatment's effectiveness.

Gender

ALL

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 (≤) 160 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 and for at least 3 months prior to the study enrollment
• • 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 planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy during trial participation.
• • 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. History of clinically significant hyponatremia within 1 year prior to Screening
• • 8. eGFR less than (\<) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at Screening
• • 9. History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness
• • 10. Diagnosed with Child-Pugh Class C
• • 11. Participants who regularly use caffeine stimulants or participants who are unwilling to reduce intake to 300 mg per day (approximately 3 cups of coffee), 1 week prior to Screening
• • 12. Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit
• • 13. Use of supplemental oxygen
• • 14. Women who are pregnant, plan to become pregnant, or are breastfeeding
• • 15. Hospitalization for the treatment of urgent or emergent hypertension within 1 year prior to Screening
• • 16. Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
• • 17. Previously diagnosed, recurrent orthostatic hypotension
• • 18. Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study
• • 19. Classified as a New York Heart Association (NYHA) Class III or IV at the Screening Visit