COMPLETED

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

Conditions

Obstructive Sleep Apnea Hypertension Blood Pressure Hypertensive Sleep Apnea

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-02-28

Study Completion:2025-12-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06785454

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Locations (Sites)

The University of Alabama

Tuscaloosa, Alabama, 35401

United States

Chandler Clinical Trials

Chandler, Arizona, 85224

United States

Preferred Research Partners Inc.

Little Rock, Arkansas, 72211

United States

Orange County Research Institute

Anaheim, California, 92801

United States

The Neurology Center of Southern California - Profound Research, LLC

Carlsbad, California, 92011

United States

Probe Clinical Research Corporation

Riverside, California, 92501

United States

Research Carolina Elite

Denver, Colorado, 28037

United States

Nouvelle Clinical Research

Cutler Bay, Florida, 33189

United States

Arrow Clinical Trials

Daytona Beach, Florida, 32117

United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida, 33176

United States

CNS Healthcare - Orlando (Clinical Neuroscience Solutions)

Orlando, Florida, 32801

United States

NeuroTrials Research Inc

Atlanta, Georgia, 30328

United States

Centricity Research Rincon Pulmonology

Rincon, Georgia, 31326

United States

Chicago Research Center Inc

Chicago, Illinois, 60634

United States

Centennial Medical Group

Columbia, Maryland, 21045

United States

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854

United States

Henry Ford Health System/Henry Ford Medical Center - Columbus

Novi, Michigan, 48377

United States

Revive Research Institute, Inc

Southfield, Michigan, 48075

United States

Healthcare Research Network

Hazelwood, Missouri, 63042

United States

Clayton Sleep Institute

St Louis, Missouri, 63123

United States

Patient First MD

Middletown, New Jersey, 07748

United States

CTI Clinical Research Center

Cincinnati, Ohio, 45212

United States

Northwest Research Center

Portland, Oregon, 97202

United States

CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

Memphis, Tennessee, 38119

United States

Huntsville Research Institute LLC

Huntsville, Texas, 77340

United States

Sleep Therapy Research Center

San Antonio, Texas, 78229

United States

University of Washington

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Mineralys Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28

Study Completion Date2025-12-29

Study Record Updates

Study Start Date2025-02-28

Study Completion Date2025-12-29

Terms related to this study

Keywords Provided by Researchers

Blood Pressure
Hypertension
Hypertensive
Sleep Apnea
Obstructive Sleep Apnea

Additional Relevant MeSH Terms

Obstructive Sleep Apnea
Hypertension