Lorundrostat for Obstructive Sleep Apnea and High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of lorundrostat in helping individuals with both moderate to severe obstructive sleep apnea (a condition where breathing repeatedly stops and starts during sleep) and high blood pressure. Participants will receive either lorundrostat or a placebo (a pill with no active medicine) to determine if the drug reduces sleep apnea events. Suitable candidates have a BMI of 27 or higher, a diagnosis of moderate-to-severe sleep apnea, and high blood pressure. If using CPAP machines for sleep apnea, they should have used them for at least four hours each night for three months before joining the trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking MRAs (mineralocorticoid receptor antagonists) and ENaC (epithelial sodium channel) inhibitors at least 1 month before the screening visit. If you are on a GLP-1 agonist, you cannot participate in the trial.
Is there any evidence suggesting that lorundrostat is likely to be safe for humans?
A previous study showed that lorundrostat effectively lowered blood pressure in individuals with difficult-to-manage hypertension, suggesting it might be well-tolerated. Participants taking lorundrostat achieved better results than those on a placebo. Research has also shown that lorundrostat can improve heart and kidney health by reducing blood pressure and certain proteins in the urine. While these findings are encouraging, they are part of ongoing research. As the trial is in the middle stages, some evidence of safety exists, but more research is needed to fully understand the treatment's safety for humans.12345
Why do researchers think this study treatment might be promising for obstructive sleep apnea?
Researchers are excited about lorundrostat because, unlike standard treatments for obstructive sleep apnea and high blood pressure that often involve lifestyle changes, CPAP machines, or medications like ACE inhibitors and ARBs, this drug works differently. Lorundrostat targets a novel mechanism by inhibiting the enzyme responsible for producing aldosterone, a hormone that can raise blood pressure and contribute to sleep apnea issues. This unique action could potentially offer a dual benefit by addressing both conditions simultaneously, providing a more streamlined treatment option. In addition, lorundrostat is promising because it may offer a new approach for patients who haven't had success with existing therapies.
What evidence suggests that lorundrostat might be an effective treatment for obstructive sleep apnea and high blood pressure?
Research has shown that lorundrostat may lower high blood pressure and improve symptoms of obstructive sleep apnea (OSA). In earlier studies, lorundrostat significantly reduced the average blood pressure over 24 hours in individuals with treatment-resistant high blood pressure. This suggests potential benefits for those with both high blood pressure and OSA. Participants in this trial will receive lorundrostat in one of two sequences: starting with lorundrostat followed by a placebo, or starting with a placebo followed by lorundrostat. The drug reduces aldosterone, a hormone that can influence blood pressure, especially when taken at night. While more information on its effects on OSA is still being gathered, the mechanism and early results show promise for easing sleep apnea symptoms.13567
Are You a Good Fit for This Trial?
This trial is for adults with a BMI ≥27 who have moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with an AHI of ≥15 events/hr. They should not be on PAP therapy or planning to start it during the study. Participants must use effective contraception if they can have children.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either Lorundrostat or placebo for 4 weeks
Washout
A 2-week washout period between treatment phases
Treatment Period 2
Participants crossover to receive the alternate treatment (Lorundrostat or placebo) for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lorundrostat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mineralys Therapeutics Inc.
Lead Sponsor