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Could this pill treat sleep apnea and hypertension at once?

NCT ID NCT06785454

Disease control Sponsor: Mineralys Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase 2 trial tested a drug called lorundrostat in 48 adults with moderate-to-severe obstructive sleep apnea and high blood pressure. Participants took either the drug or a placebo for four weeks to see if it improved breathing during sleep and lowered blood pressure. The study is complete, and results will show whether this approach is worth testing further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lorundrostat
What this could lead to
If successful, this could point toward a new oral treatment that reduces both sleep apnea severity and high blood pressure.
What could go wrong
This is a small, early-phase trial (48 people) with short follow-up. Results may not hold in larger studies or real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Started

Feb 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (\<) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at Screening using serum creatinine or cystatin-C 8. History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness 9. Diagnosed with Child-Pugh Class C 10. Participants who regularly use caffeine stimulants or participants who are unwilling to reduce intake to 300 mg per day (approximately 3 cups of coffee), for a period of at least 3 days prior to the Screening visit or a sleep study 11. Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit 12. Requirement for nocturnal use of supplemental oxygen 13. Women who are pregnant, plan to become pregnant, or are breastfeeding 14. Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening 15. Previously diagnosed, recurrent orthostatic hypotension 16. Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Obstructive sleep apnea

Contacts and locations

Locations

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117, United States

  • CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

    Memphis, Tennessee, 38119, United States

  • CNS Healthcare - Orlando (Clinical Neuroscience Solutions)

    Orlando, Florida, 32801, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Centennial Medical Group

    Columbia, Maryland, 21045, United States

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31326, United States

  • Chandler Clinical Trials

    Chandler, Arizona, 85224, United States

  • Chicago Research Center Inc

    Chicago, Illinois, 60634, United States

  • Clayton Sleep Institute

    St Louis, Missouri, 63123, United States

  • Healthcare Research Network

    Hazelwood, Missouri, 63042, United States

  • Henry Ford Health System/Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377, United States

  • Huntsville Research Institute LLC

    Huntsville, Texas, 77340, United States

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328, United States

  • Northwest Research Center

    Portland, Oregon, 97202, United States

  • Nouvelle Clinical Research

    Cutler Bay, Florida, 33189, United States

  • Orange County Research Institute

    Anaheim, California, 92801, United States

  • Patient First MD

    Middletown, New Jersey, 07748, United States

  • PharmaDev Clinical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Preferred Research Partners Inc.

    Little Rock, Arkansas, 72211, United States

  • Probe Clinical Research Corporation

    Riverside, California, 92501, United States

  • Research Carolina Elite

    Denver, Colorado, 28037, United States

  • Revive Research Institute, Inc

    Southfield, Michigan, 48075, United States

  • Sleep Therapy Research Center

    San Antonio, Texas, 78229, United States

  • The Neurology Center of Southern California - Profound Research, LLC

    Carlsbad, California, 92011, United States

  • The University of Alabama

    Tuscaloosa, Alabama, 35401, United States

  • University of Washington

    Seattle, Washington, 98104, United States

  • Velocity Clinical Research, Rockville

    Rockville, Maryland, 20854, United States

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