NCT06785454CompletedPhase 2
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 16 Jan 2025
- Start date
- 28 Feb 2025
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- Mineralys Therapeutics Inc.
- Diseases
- High blood pressure
- NCT number
- NCT06785454
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 48
- From 28 Feb 2025 to the primary completion date, 17 Dec 2025
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Use of bilevel positive airway pressure (BiPAP) therapy.
- 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
- Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
- Previously diagnosed, recurrent orthostatic hypotension
Other illness
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
- History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness
Lab values
- 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
- 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
- Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit
Other
- Participants on a glucagon-like peptide-1 (GLP-1) agonist.
- Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- Diagnosed with Child-Pugh Class C
- Requirement for nocturnal use of supplemental oxygen
- Women who are pregnant, plan to become pregnant, or are breastfeeding
- Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orange County Research Institute Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| NeuroTrials Research Inc Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| The Neurology Center of Southern California - Profound Research, LLC Coordinator of this site? Confirm its status | Carlsbad | United States | Unknown status |
| Chandler Clinical Trials Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Chicago Research Center Inc. Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| CTI Clinical Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Centennial Medical Group Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nouvelle Clinical Research Coordinator of this site? Confirm its status | Cutler Bay | United States | Unknown status |
| Arrow Clinical Trials Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
| Research Carolina Elite Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Healthcare Research Network Coordinator of this site? Confirm its status | Hazelwood | United States | Unknown status |
| Huntsville Research Institute, LLC Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Preferred Research Partners, Inc Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis) Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| PharmaDev Clinical Research Institute, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Patient First MD Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Henry Ford Health System/Henry Ford Medical Center - Columbus Coordinator of this site? Confirm its status | Novi | United States | Unknown status |
| CNS Healthcare - Orlando (Clinical Neuroscience Solutions) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Northwest Research Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Centricity Research Rincon Pulmonology Coordinator of this site? Confirm its status | Rincon | United States | Unknown status |
| Probe Clinical Research Corporation Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| Velocity Clinical Research, Rockville Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Sleep Therapy Research Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Revive Research Institute, Inc Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Clayton Sleep Institute Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| The University of Alabama Coordinator of this site? Confirm its status | Tuscaloosa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.