Clinical trial NCT06785454: A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Hypertension
Keywords: Blood Pressure
Hypertension
Hypertensive
Sleep Apnea
Obstructive Sleep Apnea
Lead sponsor: Mineralys Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study is a randomized, double-blind (DB), placebo controlled, crossover study. A 3-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 of age 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.

Eligibility 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

Primary outcomes:
measure: Placebo-adjusted Change From Baseline in AHI at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4
timeFrame: Baseline, Week 4
measure: Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4
timeFrame: Baseline, Week 4
measure: Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4
timeFrame: Baseline, Week 4
measure: Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4
timeFrame: Baseline, Week 4
measure: Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4
timeFrame: Baseline, Week 4
measure: Placebo-adjusted Change From Baseline in PROMIS Sleep-Related Impairment (SRI) at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: The University of Alabama
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Carlsbad
country: United States
facility: The Neurology Center of Southern California - Profound Research, LLC
state: California
city: Riverside
country: United States
facility: Probe Clinical Research Corporation
state: California
city: Rolling Hills Estates
country: United States
facility: Headlands Research - Peninsula Research Associates
state: California
city: Denver
country: United States
facility: Research Carolina Elite
state: Colorado
city: Cutler Bay
country: United States
facility: Nouvelle Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Miami
country: United States
facility: PharmaDev Clinical Research Institute, LLC
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Rincon
country: United States
facility: Centricity Research Rincon Pulmonology
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center Inc
state: Illinois
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research, Rockville
state: Maryland
city: Novi
country: United States
facility: Henry Ford Health System/Henry Ford Medical Center - Columbus
state: Michigan
city: Southfield
country: United States
facility: Revive Research Institute, Inc
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Middletown
country: United States
facility: Patient First MD
state: New Jersey
city: Albuquerque
country: United States
facility: The Sleep Spot Maimonides
state: New Mexico
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Memphis
country: United States
facility: CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
state: Tennessee
city: Huntsville
country: United States
facility: Huntsville Research Institute LLC
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
Study officials:
References: