Obstructive Sleep ApneaPhase 2NCT06785454
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
A Phase 2 study testing Lorundrostat in people with Obstructive Sleep Apnea and Hypertension, run by Mineralys Therapeutics Inc. at 27 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- Lorundrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 27 sitesUnited States
- Study dates
- 28 Feb 2025to 29 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m^2)
- Previously diagnosed with moderate-to-severe OSA
- AHI ≥15 events per hour (/hr) prior to Randomization
- 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
- 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)
- Participants not currently on PAP therapy, and not anticipated to start PAP for the duration of the study
- 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
Who cannot join
- 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
- Participants on a glucagon-like peptide-1 (GLP-1) agonist.
- 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.
- Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
- Use of bilevel positive airway pressure (BiPAP) therapy.
Show all 16Show fewer
- 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
- History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness
- Diagnosed with Child-Pugh Class C
- 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
- Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit
- Requirement for nocturnal use of supplemental oxygen
- Women who are pregnant, plan to become pregnant, or are breastfeeding
- Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
- Previously diagnosed, recurrent orthostatic hypotension
- Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Orange County Research Institute
Anaheim, California, 92801
NeuroTrials Research Inc
Atlanta, Georgia, 30328
The Neurology Center of Southern California - Profound Research, LLC
Carlsbad, California, 92011
Chandler Clinical Trials
Chandler, Arizona, 85224
Chicago Research Center Inc
Chicago, Illinois, 60634
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Centennial Medical Group
Columbia, Maryland, 21045
Nouvelle Clinical Research
Cutler Bay, Florida, 33189
Arrow Clinical Trials
Daytona Beach, Florida, 32117
Research Carolina Elite
Denver, Colorado, 28037
Healthcare Research Network
Hazelwood, Missouri, 63042
Huntsville Research Institute LLC
Huntsville, Texas, 77340
Preferred Research Partners Inc.
Little Rock, Arkansas, 72211
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
Memphis, Tennessee, 38119
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
Patient First MD
Middletown, New Jersey, 07748
Henry Ford Health System/Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
Orlando, Florida, 32801
Northwest Research Center
Portland, Oregon, 97202
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31326
Probe Clinical Research Corporation
Riverside, California, 92501
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Sleep Therapy Research Center
San Antonio, Texas, 78229
University of Washington
Seattle, Washington, 98104
Revive Research Institute, Inc
Southfield, Michigan, 48075
Clayton Sleep Institute
St Louis, Missouri, 63123
The University of Alabama
Tuscaloosa, Alabama, 35401
About this study
Official title: A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension
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.
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Being tested
- Lorundrostat, Placebo
- Keywords
- Blood Pressure, Hypertension, Hypertensive, Sleep Apnea, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorundrostatDrug
Lorundrostat tablet.
PlaceboDrug
Lorundrostat matching placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Lorundrostat then Placebo | Experimental | Not described Receives: Drug: Lorundrostat; Drug: Placebo |
| Sequence 2: Placebo then Lorundrostat | Experimental | Not described Receives: Drug: Lorundrostat; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-adjusted Change From Baseline in AHI at Week 4
Measured: Baseline, Week 4
Secondary outcomes (6)
Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4
Measured: Baseline, Week 4
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4
Measured: Baseline, Week 4
Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4
Measured: Baseline, Week 4
Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4
Measured: Baseline, Week 4
Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4
Measured: Baseline, Week 4
Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start28 Feb 2025
- Primary completion17 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mineralys Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785454
- Sponsor's protocol ID
- MLS-101-207
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Crossover Study to Evaluate the Efficacy and Safety of Lorundrostat in Participants With Moderate to Severe Obstructive Sleep Apnea and Hypertension
- ClinicalTrials.gov ID
- NCT06785454
- Acronym / sponsor ID
- MLS-101-207
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Keywords
- Blood Pressure, Hypertension, Hypertensive, Sleep Apnea, Obstructive Sleep Apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mineralys Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Lorundrostat then Placebo | Experimental | Drug: Lorundrostat, Drug: Placebo |
| Sequence 2: Placebo then Lorundrostat | Experimental | Drug: Lorundrostat, Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m^2)
- Previously diagnosed with moderate-to-severe OSA
- AHI ≥15 events per hour (/hr) prior to Randomization
- 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
- 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)
Key exclusion criteria (16 listed)
- 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
- Participants on a glucagon-like peptide-1 (GLP-1) agonist.
- 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.
- Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorundrostatLorundrostat tablet. | Drug | Sequence 1: Lorundrostat then Placebo, Sequence 2: Placebo then Lorundrostat |
| PlaceboLorundrostat matching placebo tablet. | Drug | Sequence 1: Lorundrostat then Placebo, Sequence 2: Placebo then Lorundrostat |
Primary outcome
Placebo-adjusted Change From Baseline in AHI at Week 4
Time frame: Baseline, Week 4
6 secondary outcomes
Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4
Time frame: Baseline, Week 4
Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4
Time frame: Baseline, Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lorundrostat in people with Obstructive Sleep Apnea and Hypertension, run by Mineralys Therapeutics Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-adjusted Change From Baseline in AHI at Week 4 (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.