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

NCT ID: NCT06785454

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-12-29

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1: Lorundrostat then Placebo

Group Type: EXPERIMENTAL

Lorundrostat

Intervention Type: DRUG

Lorundrostat tablet.

Placebo

Intervention Type: DRUG

Lorundrostat matching placebo tablet.

Sequence 2: Placebo then Lorundrostat

Group Type: EXPERIMENTAL

Lorundrostat

Intervention Type: DRUG

Lorundrostat tablet.

Placebo

Intervention Type: DRUG

Lorundrostat matching placebo tablet.

Interventions

Lorundrostat

Lorundrostat tablet.

Intervention Type: DRUG

Placebo

Lorundrostat matching placebo tablet.

Intervention Type: DRUG

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 (≤) 180 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 (documented) and for at least 3 months prior to the study enrollment (documented)

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 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.

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. 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

8. History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness

9. Diagnosed with Child-Pugh Class C

10. 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

11. Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month of the Screening Visit

12. Requirement for nocturnal use of supplemental oxygen

13. Women who are pregnant, plan to become pregnant, or are breastfeeding

14. Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening

15. Previously diagnosed, recurrent orthostatic hypotension

16. Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mineralys Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Alabama

Tuscaloosa, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Preferred Research Partners Inc.

Little Rock, Arkansas, United States

Orange County Research Institute

Anaheim, California, United States

The Neurology Center of Southern California - Profound Research, LLC

Carlsbad, California, United States

Probe Clinical Research Corporation

Riverside, California, United States

Research Carolina Elite

Denver, Colorado, United States

Nouvelle Clinical Research

Cutler Bay, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida, United States

CNS Healthcare - Orlando (Clinical Neuroscience Solutions)

Orlando, Florida, United States

NeuroTrials Research Inc

Atlanta, Georgia, United States

Centricity Research Rincon Pulmonology

Rincon, Georgia, United States

Chicago Research Center Inc

Chicago, Illinois, United States

Centennial Medical Group

Columbia, Maryland, United States

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

Henry Ford Health System/Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Revive Research Institute, Inc

Southfield, Michigan, United States

Healthcare Research Network

Hazelwood, Missouri, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Patient First MD

Middletown, New Jersey, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Northwest Research Center

Portland, Oregon, United States

CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

Memphis, Tennessee, United States

Huntsville Research Institute LLC

Huntsville, Texas, United States

Sleep Therapy Research Center

San Antonio, Texas, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

MLS-101-207

Identifier Type: -

Identifier Source: org_study_id