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CompletedNCT06785454Updated Aug 21, 2026

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

A Phase 2 interventional study of Lorundrostat and Placebo in Obstructive Sleep Apnea and Hypertension, sponsored by Mineralys Therapeutics Inc.. Completed at 27 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Mineralys Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

The study is a randomized, double-blind (DB), placebo controlled, crossover study. A 4-week screening period is followed by two DB 4-week treatment periods separated by a 2-week washout period. Participants must be 18 to 75 years old with moderate to severe OSA, hypertension and meet all applicable eligibility criteria. Participants who are medically prescribed and deemed compliant with positive airway pressure (PAP) therapy for greater than or equal to (>=) 4 hours per night (Continuous PAP [CPAP], or automatic PAP [autoPAP]) and for at least 3 months prior to the study enrollment are eligible for the study. Participants on PAP therapy should comply with PAP therapy for the duration of the study. Participants who are not currently on PAP therapy and not anticipated to start PAP for the duration of the study, are also eligible for the study.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Hypertension

Keywords

  • Blood Pressure
  • Hypertension
  • Hypertensive
  • Sleep Apnea
  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's enrollment of 48 is close to the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Mineralys Therapeutics Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Sequence 1: Lorundrostat then Placebo

    Drug: Lorundrostat · Drug: Placebo

  • Experimental
    Sequence 2: Placebo then Lorundrostat

    Drug: Lorundrostat · Drug: Placebo

Interventions

  • DrugLorundrostat

    Lorundrostat tablet.

  • DrugPlacebo

    Lorundrostat matching placebo tablet.

06

What researchers measure

Primary outcomes

  1. Placebo-adjusted Change From Baseline in AHI at Week 4

    Time frame: Baseline, Week 4

Secondary outcomes

  1. Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4

    Time frame: Baseline, Week 4

  2. Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4

    Time frame: Baseline, Week 4

  3. Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4

    Time frame: Baseline, Week 4

  4. Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4

    Time frame: Baseline, Week 4

  5. Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4

    Time frame: Baseline, Week 4

  6. Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4

    Time frame: Baseline, Week 4

07

Study locations

27 sites
  • The University of Alabama
    Tuscaloosa, Alabama 35401, United States
  • Chandler Clinical Trials
    Chandler, Arizona 85224, United States
  • Preferred Research Partners Inc.
    Little Rock, Arkansas 72211, United States
  • Orange County Research Institute
    Anaheim, California 92801, United States
  • The Neurology Center of Southern California - Profound Research, LLC
    Carlsbad, California 92011, United States
  • Probe Clinical Research Corporation
    Riverside, California 92501, United States
  • Research Carolina Elite
    Denver, Colorado 28037, United States
  • Nouvelle Clinical Research
    Cutler Bay, Florida 33189, United States
  • Arrow Clinical Trials
    Daytona Beach, Florida 32117, United States
  • PharmaDev Clinical Research Institute, LLC
    Miami, Florida 33176, United States
  • CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
    Orlando, Florida 32801, United States
  • NeuroTrials Research Inc
    Atlanta, Georgia 30328, United States
  • Centricity Research Rincon Pulmonology
    Rincon, Georgia 31326, United States
  • Chicago Research Center Inc
    Chicago, Illinois 60634, United States
  • Centennial Medical Group
    Columbia, Maryland 21045, United States
  • Velocity Clinical Research, Rockville
    Rockville, Maryland 20854, United States
  • Henry Ford Health System/Henry Ford Medical Center - Columbus
    Novi, Michigan 48377, United States
  • Revive Research Institute, Inc
    Southfield, Michigan 48075, United States
  • Healthcare Research Network
    Hazelwood, Missouri 63042, United States
  • Clayton Sleep Institute
    St Louis, Missouri 63123, United States
  • Patient First MD
    Middletown, New Jersey 07748, United States
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
  • Northwest Research Center
    Portland, Oregon 97202, United States
  • CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
    Memphis, Tennessee 38119, United States
  • Huntsville Research Institute LLC
    Huntsville, Texas 77340, United States
  • Sleep Therapy Research Center
    San Antonio, Texas 78229, United States
  • University of Washington
    Seattle, Washington 98104, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06785454
Lead sponsor
Mineralys Therapeutics Inc.
Responsible party
Sponsor
First posted
Jan 21, 2025
Start date
Feb 28, 2025
Primary completion
Dec 17, 2025
Completion
Dec 29, 2025
Last update
Aug 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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