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Assessing Lorundrostat for 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

PHASE2 · Mineralys Therapeutics Inc. · NCT06785454

This study is testing if an oral medication called lorundrostat can help people with moderate to severe obstructive sleep apnea and high blood pressure feel better.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorMineralys Therapeutics Inc. (industry)
Locations28 sites (Tuscaloosa, Alabama and 27 other locations)
Trial IDNCT06785454 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of lorundrostat, an oral medication, in participants suffering from moderate to severe obstructive sleep apnea (OSA) and hypertension. It employs a randomized, double-blind, placebo-controlled, crossover design, consisting of a 3-week screening period followed by two 4-week treatment phases separated by a 2-week washout. Eligible participants must be between 18 to 75 years old, have a body mass index of 27 or higher, and meet specific criteria related to their OSA and blood pressure levels. The study aims to determine the impact of lorundrostat on the Apnea-Hypopnea Index (AHI).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with moderate to severe obstructive sleep apnea and hypertension who are compliant with positive airway pressure therapy.

Not a fit: Patients with poorly controlled type 2 diabetes or those not currently on positive airway pressure therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve sleep quality and blood pressure control for patients with obstructive sleep apnea and hypertension.

How similar studies have performed: Other studies have shown promise in treating obstructive sleep apnea and hypertension, but the specific use of lorundrostat in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 (≤) 160 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 and for at least 3 months prior to the study enrollment
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 planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy during trial participation.
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. History of clinically significant hyponatremia within 1 year prior to Screening
8. eGFR less than (\<) 45 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) at Screening
9. History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness
10. Diagnosed with Child-Pugh Class C
11. Participants who regularly use caffeine stimulants or participants who are unwilling to reduce intake to 300 mg per day (approximately 3 cups of coffee), 1 week prior to Screening
12. Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit
13. Use of supplemental oxygen
14. Women who are pregnant, plan to become pregnant, or are breastfeeding
15. Hospitalization for the treatment of urgent or emergent hypertension within 1 year prior to Screening
16. Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
17. Previously diagnosed, recurrent orthostatic hypotension
18. Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study
19. Classified as a New York Heart Association (NYHA) Class III or IV at the Screening Visit

Where this trial is running

Tuscaloosa, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Obstructive Sleep Apnea, Hypertension, Blood Pressure, Hypertensive, Sleep Apnea

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.