Lorundrostat for Obstructive Sleep Apnea and High Blood Pressure
Recruiting at 27 trial locations
SB
Overseen ByShivani Bhikam
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mineralys Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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
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
I agree to use effective birth control during and up to 28 days after the study.
I have been using CPAP or PAP therapy for at least 4 hours each night for over 3 months.
I am not using PAP therapy and don't plan to start it during the study.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
3 weeks
Treatment Period 1
Participants receive either Lorundrostat or placebo for 4 weeks
4 weeks
Washout
A 2-week washout period between treatment phases
2 weeks
Treatment Period 2
Participants crossover to receive the alternate treatment (Lorundrostat or placebo) for 4 weeks
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Lorundrostat
Trial Overview The trial is testing Lorundrostat, taken once daily by mouth, against a placebo to see its effect on the Apnea-Hypopnea Index in people with OSA and high blood pressure.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sequence 2: Placebo then LorundrostatExperimental Treatment2 Interventions
Group II: Sequence 1: Lorundrostat then PlaceboExperimental Treatment2 Interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mineralys Therapeutics Inc.
Lead Sponsor
Trials
6
Recruited
3,100+
Founded
2019
Headquarters
Radnor, USA
Known For
Hypertension treatments
Top Products
Lorundrostat
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