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

NCT06785454 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MLS-101-207
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 27

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.

Conditions

Obstructive Sleep Apnea; Hypertension

Keywords

Blood Pressure; Hypertension; Hypertensive; Sleep Apnea; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Placebo-adjusted Change From Baseline in AHI at Week 4

  Baseline, Week 4

Secondary Outcomes (6)

• Placebo-adjusted Change From Baseline in Nighttime Average Systolic Blood Pressure (SBP) at Week 4

  Baseline, Week 4

• Placebo-adjusted Change From Baseline in Automated Office Blood Pressure (AOBP) SBP at Week 4

  Baseline, Week 4

• Placebo-adjusted Change From Baseline in Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) at Week 4

  Baseline, Week 4

• Placebo-adjusted Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 4

  Baseline, Week 4

• Placebo-adjusted Change From Baseline in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS-SD) at Week 4

  Baseline, Week 4

Study Arms (2)

Sequence 1: Lorundrostat then Placebo

EXPERIMENTAL

Drug: Lorundrostat; Drug: Placebo

Sequence 2: Placebo then Lorundrostat

EXPERIMENTAL

Drug: Lorundrostat; Drug: Placebo

Interventions

Lorundrostat DRUG

Lorundrostat tablet.

Sequence 1: Lorundrostat then Placebo; Sequence 2: Placebo then Lorundrostat

Placebo DRUG

Lorundrostat matching placebo tablet.

Sequence 1: Lorundrostat then Placebo; Sequence 2: Placebo then Lorundrostat

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Participants on a glucagon-like peptide-1 (GLP-1) agonist.
• 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.
• Have diagnosis of central or mixed sleep apnea with % of mixed or central apneas/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, other than 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 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
• Treatment with MRAs and/or epithelial sodium channel (ENaC) inhibitors within 1 month 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 6 months prior to Screening
• Previously diagnosed, recurrent orthostatic hypotension

Sponsors & Collaborators

• Mineralys Therapeutics Inc.: lead

Study Sites (27)

The University of Alabama

Tuscaloosa, Alabama, 35401, United States

Location

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

Location

Preferred Research Partners Inc.

Little Rock, Arkansas, 72211, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

The Neurology Center of Southern California - Profound Research, LLC

Carlsbad, California, 92011, United States

Location

Probe Clinical Research Corporation

Riverside, California, 92501, United States

Location

Research Carolina Elite

Denver, Colorado, 28037, United States

Location

Nouvelle Clinical Research

Cutler Bay, Florida, 33189, United States

Location

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

Location

PharmaDev Clinical Research Institute, LLC

Miami, Florida, 33176, United States

Location

CNS Healthcare - Orlando (Clinical Neuroscience Solutions)

Orlando, Florida, 32801, United States

Location

NeuroTrials Research Inc

Atlanta, Georgia, 30328, United States

Location

Centricity Research Rincon Pulmonology

Rincon, Georgia, 31326, United States

Location

Chicago Research Center Inc

Chicago, Illinois, 60634, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

Location

Henry Ford Health System/Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

Revive Research Institute, Inc

Southfield, Michigan, 48075, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Patient First MD

Middletown, New Jersey, 07748, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

CNS Healthcare - Memphis (Clinical Neuroscience Solutions - Memphis)

Memphis, Tennessee, 38119, United States

Location

Huntsville Research Institute LLC

Huntsville, Texas, 77340, United States

Location

Sleep Therapy Research Center

San Antonio, Texas, 78229, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: February 28, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 29, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)