Clinical trial NCT05968430: Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Official title: An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hypertension
Keywords: Blood pressure
Uncontrolled hypertension
Hypertension
Hypertensive
Lead sponsor: Mineralys Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

Detailed description: The purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension.

This study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. Eligible subjects for MLS-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (ICF), to transition to this open label extension (OLE) study at either the end-of-study (EoS) visit or the end-of-treatment (EoT) visit as required in the parent study protocol.

A Randomized Treatment Withdrawal (RTW) substudy will be performed in a subset of subjects meeting eligibility criteria.

Subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent signed by the participant, obtained before any study-related assessment is performed
2. At least 18 years of age at the time of signing the informed consent form (ICF)
3. Completed the EoT or EoS Visit (as applicable) in a lorundrostat study with the option of transitioning to the OLE study, in accordance with the parent study protocol
4. Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug
5. Willing and able to comply with the study instructions and attend all scheduled study visits

   \[Randomized treatment withdrawal substudy only\]
6. Written informed consent to participate in the RTW substudy signed by the participant, obtained before any RTW study-related assessment is performed

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant, or are breast-feeding
2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1 of the protocol
3. In the opinion of the Investigator, any condition that will preclude participation in the study

   \[Randomized treatment withdrawal substudy only\]
4. Non-compliance with study medication(s) (defined as taking \<75% or \>125% of the study drug provided) during the first 12 weeks of MLS-101-901

Primary outcomes:
measure: Change from MLS-101-301 baseline automated office blood pressure
timeFrame: Week 36
measure: Change at MLS-101-901 Week 16 (RTW Week 4) from MLS 101-901 Week 12 (RTW substudy baseline) in AOBP SBP in subjects enrolled in RTW
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites (ARS) - Birmingham Clinical Research Unit
state: Alabama
city: Foley
country: United States
facility: G & L Research LLC
state: Alabama
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Glendale
country: United States
facility: Arizona Kidney
state: Arizona
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, AZ
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Entertainment Medical Group, Inc
state: California
city: Chula Vista
country: United States
facility: CA Institute of Renal Research, CA
state: California
city: Fairfield
country: United States
facility: Amicis Research Center - Vacaville
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center - Granada Hills
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research 002, LLC
state: California
city: La Jolla
country: United States
facility: University of California San Diego (UCSD) - Altman Clinical and Translational Research Institute (ACTRI)
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research (CTR) - Lincoln
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute (AMRI) - Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Northridge
country: United States
facility: Amicis Research Center - Mission Hills
state: California
city: Northridge
country: United States
facility: Amicis Research Center-Northridge
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Trials
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research (CTR) - Sacramento
state: California
city: San Diego
country: United States
facility: Triwest Research Associates
state: California
city: San Jose
country: United States
facility: San Jose Clinical Trials
state: California
city: Valencia
country: United States
facility: Amicis Research Center - Valencia
state: California
city: Victorville
country: United States
facility: Kidney & Hypertension Center - Victorville
state: California
city: Vista
country: United States
facility: Blue Coast Research Center (BCRC)
state: California
city: Vista
country: United States
facility: Accelerated Enrollment Solutions (AES) -Vista/Synexus (Radiant Research)
state: California
city: Denver
country: United States
facility: Colorado Kidney (Denver) Nephrology
state: Colorado
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Miami
country: United States
facility: Nuovida Research Center Corp
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Orlando
country: United States
facility: Nephrology Associates of Central Florida
state: Florida
city: Orlando
country: United States
facility: AES - Orlando
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sanford
country: United States
facility: Infigo Clinical Research (Mid Florida)
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: The Villages
country: United States
facility: AES The Villages
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Diabetes and Endocrine Specialists, PA (PBDES) - West Palm Beach Office)
state: Florida
city: Acworth
country: United States
facility: American Clinical Trials
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Brunswick
country: United States
facility: Coastal Medical
state: Georgia
city: Decatur
country: United States
facility: Accel Research Sites
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Clinical Research, LLC
state: Georgia
city: Peachtree Corners
country: United States
facility: Alta Pharmaceutical Research Center
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Meridian Family Medicine
state: Idaho
city: Chicago
country: United States
facility: AES Chicago/Synexus Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Eagle Clinical Research
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine, S.C
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois School of Medicine
state: Illinois
city: Brownsburg
country: United States
facility: Hendricks Regional Health Medical Group - Lizton Family Medicine
state: Indiana
city: Evansville
country: United States
facility: AES Evansville/Synexus Clinical Research
state: Indiana
city: Hammond
country: United States
facility: ASHA Clinical Research- Munster, LLC
state: Indiana
city: Lexington
country: United States
facility: The Research Group of Lexington, LLC
state: Kentucky
city: Louisville
country: United States
facility: Nephrology Associates of Kentuckiana
state: Kentucky
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology, LLC - Shreveport
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActiveMed Practices & Research LLC
state: Massachusetts
city: Petal
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research Network-Hazelwood
state: Missouri
city: Kansas City
country: United States
facility: Clinical Research Consultants (CRC) - Kansas City
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Henderson
country: United States
facility: AES - Nevada
state: Nevada
city: Henderson
country: United States
facility: Henderson Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Oasis Clinical Trials
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: AES New York/Synexus Clinical Research
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Asheboro
country: United States
facility: Triad Internal Medicine
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University (ECU) Physicians - East Carolina Heart Institute - East Carolina University Location
state: North Carolina
city: Greenville
country: United States
facility: Physician's East Endocrinology
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research
state: North Carolina
city: Beavercreek
country: United States
facility: Research Innovations (Elligo Health Research)
state: Ohio
city: Canton
country: United States
facility: Diabetes & Endocrinology Associates of Stark County
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Main Campus
state: Ohio
city: Vandalia
country: United States
facility: Arthritis & Osteoarthritis Center of SW Ohio/ dba STAT Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman (LION Research)
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Horsham
country: United States
facility: AMS Cardiology (Elligo)
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburg
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Anderson
country: United States
facility: Accelerated Enrollment Solutions (AES) - Anderson
state: South Carolina
city: Charleston
country: United States
facility: Wake Research - Notus Clinical Trials, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research
state: Tennessee
city: Knoxville
country: United States
facility: AMR - Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Memphis
country: United States
facility: Lifedoc Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center (VUMC)
state: Tennessee
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: Dallas
country: United States
facility: AES - Dallas Fort Worth
state: Texas
city: El Paso
country: United States
facility: David Turbay, MD, PLLC (Elligo Health Research)
state: Texas
city: Houston
country: United States
facility: Synergy Groups Medical - Bissonet Site
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Houston
country: United States
facility: Gulf Coast Clinical Research
state: Texas
city: Katy
country: United States
facility: Medical Colleagues of Texas, LLP (Elligo Health Research)
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research
state: Texas
city: McAllen
country: United States
facility: Gamma Medical Research, Inc
state: Texas
city: McAllen
country: United States
facility: Office of Audrey L. Jones, DO
state: Texas
city: Mesquite
country: United States
facility: PRX Research - Mesquite
state: Texas
city: Missouri City
country: United States
facility: Synergy Groups Medical - Missouri City
state: Texas
city: Plano
country: United States
facility: ACRC Trials - Legacy Medical Village Location
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas (CIT)
state: Texas
city: Plano
country: United States
facility: ACRC Trials - Legacy Medical Village
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute (SRI) - San Antonio
state: Texas
city: San Antonio
country: United States
facility: San Antonio ClinicalTrials
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice (Elligo Health Research)
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
city: Burke
country: United States
facility: Burke Internal Medicine
state: Virginia
city: Norfolk
country: United States
facility: Eastern VA Medical School
state: Virginia
city: Woodbridge
country: United States
facility: Office of Ramon Mendez
state: Virginia
city: Gosford
country: Australia
facility: Renal Research - Gosford
state: New South Wales
city: Castle Hill
country: Australia
facility: Castle Hill Medical Centre
city: Perth
country: Australia
facility: The University of Western Australia - School of Medicine and Pharmacology - Royal Perth Hospital Unit.
city: Sippy Downs
country: Australia
facility: University of Sunshine Coast Clinical Trial Centre
city: Taringa
country: Australia
facility: AusTrials - Taringa
city: Gabrovo
country: Bulgaria
facility: Medical Center New Polyclinic Gabrovo Ltd.
city: Pleven
country: Bulgaria
facility: Medical Center
city: Sofia
country: Bulgaria
facility: ASOMHIDC - Individual practice Cardio Tonus EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: DCC 1 - Veliko Tarnovo" EOOD
city: Montréal
country: Canada
facility: Centre Medical L'Acadie - Montreal
state: Quebec
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois - Site d'Annecy
city: Berlin
country: Germany
facility: Emovis GmbH
city: Deggingen
country: Germany
facility: MVZ Jung GbR
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Leipzig
country: Germany
facility: Uniklinik Leipzig, Klinik und Poliklinik für Kardiologie
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna - Policlinico S. Orsola
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: University of Messina
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: University of Rome Sapienza, AO Sant'Andrea
city: Amsterdam
country: Netherlands
facility: Amsterdam AMC
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego (SPSKM)
city: Lodz
country: Poland
facility: Futuremeds Lodz
city: Olsztyn
country: Poland
facility: Futuremeds Olsztyn
city: Olsztyn
country: Poland
facility: Etyka Osrodek Badan Klinicznych
city: Skierniewice
country: Poland
facility: Clinmedica Research
city: Warsaw
country: Poland
facility: ETG Warszawa
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Brasov
country: Romania
facility: Centrul Medical Unirea SRL Brasov (Regina Maria)
city: București
country: Romania
facility: Delta Health Care SRL Bucuresti - Spitalul Academic Ponderas (Regina Maria)
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures
city: Timisoara
country: Romania
facility: MEDICALI'S SRL Timisoara
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara
city: Badajoz
country: Spain
facility: Complejo Hospitalario Universitario de Badajoz (CHUB) (Hospital Infanta Cristina)
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Valencia
country: Spain
facility: Hospital Clínico Universitario Valencia
city: Newquay
country: United Kingdom
facility: Newquay Health Centre
state: Cornwall
city: Fowey
country: United Kingdom
facility: Fowey River Practice
state: England
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Scotland
city: Chippenham
country: United Kingdom
facility: Rowden Surgery Rowden Medical Partnership
state: Wilts
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Barts Health Nhs Trust
city: Plymouth
country: United Kingdom
facility: Knowle House Surgery
city: Torpoint
country: United Kingdom
facility: Rame Medical Limited
Study officials:
References: