Phase
Condition
Circulation Disorders
Sleep Apnea Syndromes
Stress
Treatment
Placebo
Lorundrostat
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) ≥ 27 kilograms per meter square (kg/m^2)
Previously diagnosed with moderate-to-severe OSA
AHI ≥15 events per hour (/hr) prior to Randomization
AOBP SBP of ≥130 and less than or equal to (≤) 180 millimeter of mercury (mmHg) andAOBP diastolic blood pressure (DBP) ≥60 and ≤110 mmHg
Participants on CPAP or PAP therapy are eligible provided they are on PAP for ≥4hours per night (documented) and for at least 3 months prior to the study enrollment (documented)
Participants not currently on PAP therapy, and not anticipated to start PAP for theduration of the study
Fertile male and female participants of childbearing potential, and their partners,must agree to use protocol-defined methods of highly effective contraception fromthe Screening Visit until 28 days after the last dose of study drug
Exclusion
Exclusion Criteria:
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 orhistory of diabetic ketoacidosis in the 6 months prior to the Screening Visit
Participants on a glucagon-like peptide-1 (GLP-1) agonist.
Any surgery for sleep apnea or major ear, nose or throat surgery, includingtonsillectomy and adenoidectomy within 3 months prior to Screening, or plannedduring participation in the study or within 1 month of the last study visit.
Have diagnosis of central or mixed sleep apnea with % of mixed or centralapneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
Use of bilevel positive airway pressure (BiPAP) therapy.
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
History of clinically relevant medical, behavioral, or psychiatric disorder, otherthan OSA, that is associated with insomnia or excessive sleepiness
Diagnosed with Child-Pugh Class C
Participants who regularly use caffeine stimulants or participants who are unwillingto reduce intake to 300 mg per day (approximately 3 cups of coffee), for a period ofat least 3 days prior to the Screening visit or a sleep study
Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1month of the Screening Visit
Requirement for nocturnal use of supplemental oxygen
Women who are pregnant, plan to become pregnant, or are breastfeeding
Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6months prior to Screening
Previously diagnosed, recurrent orthostatic hypotension
Current night-shift worker or anticipated to become a night-shift worker for 3 dayscontinuously during the duration of the study.
Study Design
Study Description
Connect with a study center
The University of Alabama
Tuscaloosa, Alabama 35401
United StatesSite Not Available
The University of Alabama
Tuscaloosa 4094455, Alabama 4829764 35401
United StatesSite Not Available
Chandler Clinical Trials
Chandler, Arizona 85224
United StatesSite Not Available
Chandler Clinical Trials
Chandler 5289282, Arizona 5551752 85224
United StatesSite Not Available
Preferred Research Partners Inc.
Little Rock, Arkansas 72211
United StatesSite Not Available
Preferred Research Partners Inc.
Little Rock 4119403, Arkansas 4099753 72211
United StatesSite Not Available
Orange County Research Institute
Anaheim, California 92801
United StatesSite Not Available
The Neurology Center of Southern California - Profound Research, LLC
Carlsbad, California 92011
United StatesSite Not Available
Probe Clinical Research Corporation
Riverside, California 92501
United StatesSite Not Available
Headlands Research - Peninsula Research Associates
Rolling Hills Estates, California 90274
United StatesSite Not Available
Orange County Research Institute
Anaheim 5323810, California 5332921 92801
United StatesSite Not Available
The Neurology Center of Southern California - Profound Research, LLC
Carlsbad 5334223, California 5332921 92011
United StatesSite Not Available
Probe Clinical Research Corporation
Riverside 5387877, California 5332921 92501
United StatesSite Not Available
Research Carolina Elite
Denver, Colorado 28037
United StatesSite Not Available
Research Carolina Elite
Denver 5419384, Colorado 5417618 28037
United StatesSite Not Available
Nouvelle Clinical Research
Cutler Bay, Florida 33189
United StatesSite Not Available
Arrow Clinical Trials
Daytona Beach, Florida 32117
United StatesSite Not Available
PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176
United StatesSite Not Available
CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
Orlando, Florida 32801
United StatesSite Not Available
Nouvelle Clinical Research
Cutler Bay 6332309, Florida 4155751 33189
United StatesSite Not Available
Arrow Clinical Trials
Daytona Beach 4152872, Florida 4155751 32117
United StatesSite Not Available
PharmaDev Clinical Research Institute, LLC
Miami 4164138, Florida 4155751 33176
United StatesSite Not Available
CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
Orlando 4167147, Florida 4155751 32801
United StatesSite Not Available
NeuroTrials Research Inc
Atlanta, Georgia 30328
United StatesSite Not Available
Centricity Research Rincon Pulmonology
Rincon, Georgia 31326
United StatesSite Not Available
NeuroTrials Research Inc
Atlanta 4180439, Georgia 4197000 30328
United StatesSite Not Available
Centricity Research Rincon Pulmonology
Rincon 4218882, Georgia 4197000 31326
United StatesSite Not Available
Chicago Research Center Inc
Chicago, Illinois 60634
United StatesSite Not Available
Chicago Research Center Inc
Chicago 4887398, Illinois 4896861 60634
United StatesSite Not Available
Centennial Medical Group
Columbia, Maryland 21045
United StatesSite Not Available
Velocity Clinical Research, Rockville
Rockville, Maryland 20854
United StatesSite Not Available
Centennial Medical Group
Columbia 4352053, Maryland 4361885 21045
United StatesSite Not Available
Velocity Clinical Research, Rockville
Rockville 4367175, Maryland 4361885 20854
United StatesSite Not Available
Henry Ford Health System/Henry Ford Medical Center - Columbus
Novi, Michigan 48377
United StatesSite Not Available
Revive Research Institute, Inc
Southfield, Michigan 48075
United StatesSite Not Available
Henry Ford Health System/Henry Ford Medical Center - Columbus
Novi 5004062, Michigan 5001836 48377
United StatesSite Not Available
Revive Research Institute, Inc
Southfield 5010636, Michigan 5001836 48075
United StatesSite Not Available
Healthcare Research Network
Hazelwood, Missouri 63042
United StatesSite Not Available
Clayton Sleep Institute
Saint Louis, Missouri 63123
United StatesSite Not Available
Healthcare Research Network
Hazelwood 4389967, Missouri 4398678 63042
United StatesSite Not Available
Clayton Sleep Institute
St Louis 4407066, Missouri 4398678 63123
United StatesSite Not Available
Patient First MD
Middletown, New Jersey 07748
United StatesSite Not Available
Patient First MD
Middletown 5101170, New Jersey 5101760 07748
United StatesSite Not Available
The Sleep Spot Maimonides
Albuquerque, New Mexico 87107
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212
United StatesSite Not Available
Northwest Research Center
Portland, Oregon 97202
United StatesSite Not Available
Northwest Research Center
Portland 5746545, Oregon 5744337 97202
United StatesSite Not Available
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
Memphis, Tennessee 38119
United StatesSite Not Available
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
Memphis 4641239, Tennessee 4662168 38119
United StatesSite Not Available
Huntsville Research Institute LLC
Huntsville, Texas 77340
United StatesSite Not Available
Sleep Therapy Research Center
San Antonio, Texas 78229
United StatesSite Not Available
Huntsville Research Institute LLC
Huntsville 4699540, Texas 4736286 77340
United StatesSite Not Available
Sleep Therapy Research Center
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
University of Washington
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available

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