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

Description

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.

Conditions

Obstructive Sleep Apnea, Hypertension

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

The University of Alabama, Tuscaloosa, Alabama, United States, 35401

Chandler

Chandler Clinical Trials, Chandler, Arizona, United States, 85224

Little Rock

Preferred Research Partners Inc., Little Rock, Arkansas, United States, 72211

Anaheim

Orange County Research Institute, Anaheim, California, United States, 92801

Carlsbad

The Neurology Center of Southern California - Profound Research, LLC, Carlsbad, California, United States, 92011

Riverside

Probe Clinical Research Corporation, Riverside, California, United States, 92501

Rolling Hills Estates

Headlands Research - Peninsula Research Associates, Rolling Hills Estates, California, United States, 90274

Denver

Research Carolina Elite, Denver, Colorado, United States, 28037

Cutler Bay

Nouvelle Clinical Research, Cutler Bay, Florida, United States, 33189

Daytona Beach

Arrow Clinical Trials, Daytona Beach, Florida, United States, 32117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mineralys Therapeutics Inc.,

Study Record Dates

2026-01