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NCT06785454CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (actual)
First submitted
16 Jan 2025
Start date
28 Feb 2025
Primary completion date
17 Dec 2025
Lead sponsor
Mineralys Therapeutics Inc.
NCT number
NCT06785454

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 48
  • From 28 Feb 2025 to the primary completion date, 17 Dec 2025
  • 27 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Use of bilevel positive airway pressure (BiPAP) therapy.
  • 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
  • Unstable or currently symptomatic cardiovascular disease or hospitalization in the 6 months prior to Screening
  • Previously diagnosed, recurrent orthostatic hypotension

Other illness

  • Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia
  • History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness

Lab values

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

Other

  • Participants on a glucagon-like peptide-1 (GLP-1) agonist.
  • Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
  • Diagnosed with Child-Pugh Class C
  • Requirement for nocturnal use of supplemental oxygen
  • Women who are pregnant, plan to become pregnant, or are breastfeeding
  • Current night-shift worker or anticipated to become a night-shift worker for 3 days continuously during the duration of the study.

Who the study is looking for

  • 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) and AOBP diastolic blood pressure (DBP) ≥60 and ≤110 mmHg
  • 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)
  • Participants not currently on PAP therapy, and not anticipated to start PAP for the duration 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 from the Screening Visit until 28 days after the last dose of study drug

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Orange County Research Institute
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
NeuroTrials Research Inc
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AtlantaUnited StatesUnknown status
The Neurology Center of Southern California - Profound Research, LLC
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CarlsbadUnited StatesUnknown status
Chandler Clinical Trials
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ChandlerUnited StatesUnknown status
Chicago Research Center Inc.
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
CTI Clinical Research Center
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CincinnatiUnited StatesUnknown status
Centennial Medical Group
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ColumbiaUnited StatesUnknown status
Nouvelle Clinical Research
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Cutler BayUnited StatesUnknown status
Arrow Clinical Trials
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Daytona BeachUnited StatesUnknown status
Research Carolina Elite
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DenverUnited StatesUnknown status
Healthcare Research Network
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HazelwoodUnited StatesUnknown status
Huntsville Research Institute, LLC
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HuntsvilleUnited StatesUnknown status
Preferred Research Partners, Inc
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Little RockUnited StatesUnknown status
CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)
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MemphisUnited StatesUnknown status
PharmaDev Clinical Research Institute, LLC
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MiamiUnited StatesUnknown status
Patient First MD
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MiddletownUnited StatesUnknown status
Henry Ford Health System/Henry Ford Medical Center - Columbus
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NoviUnited StatesUnknown status
CNS Healthcare - Orlando (Clinical Neuroscience Solutions)
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OrlandoUnited StatesUnknown status
Northwest Research Center
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PortlandUnited StatesUnknown status
Centricity Research Rincon Pulmonology
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RinconUnited StatesUnknown status
Probe Clinical Research Corporation
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RiversideUnited StatesUnknown status
Velocity Clinical Research, Rockville
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RockvilleUnited StatesUnknown status
Sleep Therapy Research Center
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San AntonioUnited StatesUnknown status
University of Washington
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SeattleUnited StatesUnknown status
Revive Research Institute, Inc
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SouthfieldUnited StatesUnknown status
Clayton Sleep Institute
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St LouisUnited StatesUnknown status
The University of Alabama
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TuscaloosaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.