Clinical trial • Phase III • Cardiology

LORUNDROSTAT for Hypertension

Phase III trial of LORUNDROSTAT for Hypertension.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Hypertension
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
24-04-2024
First CTIS Authorization Date
14-08-2024

Trial design

Randomised, open-label, placebo — patients will be administered placebo for 4 weeks (randomized treatment withdrawal substudy control arm). experimental comparator: lorundrostat — maintained at the same dose taken at week 12 of the main study (subjects in ole initiate at 50 mg qd unless their blinded treatment dose was permanently reduced in the parent study, in which case they start at 25 mg qd). Phase III trial in Romania, France, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo — Patients will be administered Placebo for 4 weeks (Randomized Treatment Withdrawal substudy control arm). Experimental comparator: Lorundrostat — maintained at the same dose taken at Week 12 of the main study (subjects in OLE initiate at 50 mg QD unless their blinded treatment dose was permanently reduced in the parent study, in which case they start at 25 mg QD).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
1030
Trial Duration For Participant
378

Eligibility

Recruits 1030 No vulnerable populations selected (isVulnerablePopulationSelected: false). Written informed consent is required from each subject before any study procedures; subjects must be at least 18 years old. Consent materials and separate ICF variants (e.g. Pregnant Partner, Sub-study, Optional Continuation, Withdrawal) are provided..

Pregnancy Exclusion
1.Women who are pregnant, plan to become pregnant, or are breast-feeding
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Written informed consent is required from each subject before any study procedures; subjects must be at least 18 years old. Consent materials and separate ICF variants (e.g. Pregnant Partner, Sub-study, Optional Continuation, Withdrawal) are provided.

Inclusion criteria

  • {"criterion_text":"- Written informed consent signed by the subject, obtained before any study-related assessment is performed\n- At least 18 years of age at the time of signing the ICF and capable of providing consent\n- 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\n- Fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use acceptable methods of contraception from study entry to 28 days after the last dose of study drug\n- Willing and able to comply with the study instructions and attend all scheduled study visits\n- Randomized treatment withdrawal substudy only:Written informed consent to participate in the RTW substudy signed by the subject, obtained before any RTW study-related assessment is performed\n- Randomized treatment withdrawal substudy only: Completed participation in the MLS-101-301 parent study\n- Randomized treatment withdrawal substudy only:Reduction of at least 5 mmHg in AOBP SBP from the MLS-101-301 Randomization Visit value at the MLS-101-901 Week 12 Visit"}

Exclusion criteria

  • {"criterion_text":"- 1.Women who are pregnant, plan to become pregnant, or are breast-feeding\n- 2. Use, or anticipated use during the course of the study, of a prohibited medication as listed in Section 6.7.1\n- 3. In the opinion of the Investigator, any condition that will preclude participation in the study\n- 4.Randomized treatment withdrawal substudy only: 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from MLS-101-301 baseline automated office blood pressure (AOBP) SBP at MLS-101-901 Week 36 in subjects who were enrolled in the lorundrostat arms of MLS-101-301 and were not assigned to the placebo arm of the MLS-101-901 RTW substudy (Objective: To assess the long-term maintenance of the AHT effect of lorundrostat in subjects with hypertension)","definition_or_measurement_approach":"Change from parent-study baseline in automated office blood pressure (AOBP) systolic blood pressure (SBP) measured at Week 36."}
  • {"endpoint_text":"- 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 RWT study(Objective: To assess the efficacy of lorundrostat in subjects with hypertension by conducting a double- blind, randomized treatment withdrawal (RTW) substudy)","definition_or_measurement_approach":"Change in automated office blood pressure (AOBP) SBP between RTW baseline (Week 12) and RTW Week 4 (overall study Week 16)."}
  • {"endpoint_text":"- Change from baseline to week 12 in AOBP SBP in various groups from the subjects from the parent studies (Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension)","definition_or_measurement_approach":"Change from baseline to Week 12 in automated office blood pressure (AOBP) SBP in pre-specified subject groups."}
  • {"endpoint_text":"- Change from baseline to week 12 AOBP in subjects from various groups of the parent studies(Objective: To explore the efficacy of lorundrostat at a starting dose of 25 mg QD in subjects with hypertension)","definition_or_measurement_approach":"Change from baseline to Week 12 in automated office blood pressure (AOBP) (systolic and/or diastolic per endpoint definitions) for subjects from different parent-study groups."}
  • {"endpoint_text":"- Change from MLS-101-901 baseline AOBP SBP at MLS101-901 Week 12 in subjects who were enrolled in the placebo arm of MLS-101-301 (Objective: To explore the efficacy of lorundrostat in improving BP in subjects with hypertension)","definition_or_measurement_approach":"Change from MLS-101-901 baseline in automated office blood pressure (AOBP) SBP at Week 12 for subjects who were in the placebo arm of the parent study."}
  • {"endpoint_text":"- Percent change in urine albumin creatinine ratio (UACR) from MLS 101 901 baseline by visit in the periods of exposure to lorundrostat during MLS-101-901 for subjects with albuminuria at the parent study baseline (Objective: To explore the efficacy of lorundrostat in improving albuminuria)","definition_or_measurement_approach":"Percent change from MLS-101-901 baseline in urine albumin-to-creatinine ratio (UACR) by visit during periods of exposure to lorundrostat for subjects with baseline albuminuria."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
1030
Recruitment Window Months
28
Consent Approach
Written informed consent signed by the subject is required prior to any study-related assessments; subjects must be ≥18 years and capable of providing consent. Multiple ICF and subject information documents are provided (Main ICF, Pregnant Partner ICF, Sub-study ICF, Optional Continuation, Withdrawal) and participant materials are available in multiple languages (English, French, Spanish, Dutch, Polish, Bulgarian, German, Italian, Romanian as indicated by available document translations).

Methods

  • K2 'Dear Patient Letter' (site/patient-directed recruitment letters) — documented in recruitment materials
  • Scout patient recruitment / Patient Concierge / Travel support (Scout Clinical) — sponsor third-party providing patient concierge/travel support
  • Email communications to potential participants (Scout Email communication / Participant Email Communication documents)
  • Study brochures and participant-facing materials (Scout Study Brochure; App Participant Facing material in multiple languages)
  • GP/Healthcare professional engagement via 'Dear Dr/GP Letter' and local site outreach

Geography

Total Number Of Sites
32
Total Number Of Participants
370

Romania

Earliest CTIS Part Ii Submission Date
16-05-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
480
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Delta Health Care S.R.L.
Department Name
Cardiologie
Contact Person Name
Andreea Rachieru
Contact Person Email
alis.mihai@reginamaria.ro
Site Name
Centrul Medical Unirea S.R.L.
Department Name
Cardiologie
Contact Person Name
Codrut Ioan Ciurea
Contact Person Email
raluca.ouatu@reginamaria.ro
Site Name
Medicali's S.R.L.
Department Name
Cardiologie
Contact Person Name
Minodora Andor
Contact Person Email
medicaliss@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
Cardiologie
Contact Person Name
Mihaela Viviana Ivan
Contact Person Email
judetean@hosptm.ro
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Cardiologie
Contact Person Name
Theodora Mariana Nicoleta Benedek
Contact Person Email
secretariat@spitalmures.ro

France

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
412
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Annecy Genevois
Department Name
Nephrology Department
Contact Person Name
Benoit FRANKO
Contact Person Email
bfranko@ch-annecygenevois.fr

Spain

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
403
Number Of Sites
4
Number Of Participants
50

Sites

Site Name
Hospital Universitario De Badajoz
Department Name
Nephrology
Contact Person Name
Nicolas Roberto Robles Pérez-Monteoliva
Contact Person Email
nrrobles@yahoo.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Internal Medicine
Contact Person Name
Fernando Martínez García
Contact Person Email
fermar23@uv.es
Site Name
Hospital General Universitario Reina Sofia
Department Name
Nephrology
Contact Person Name
Rafael Santamaría Olmo
Contact Person Email
rsantamariao@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hypertension
Contact Person Name
Fernando Jaén Águila
Contact Person Email
fer0602@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
445
Number Of Sites
5
Number Of Participants
35

Sites

Site Name
Medical Center Exacta Medica OOD
Contact Person Name
Nikolay Iliev
Contact Person Email
niki_iliev2002@abv.bg
Site Name
Diagnostic And Consulting Center 1 Veliko Tarnovo Ltd.
Department Name
Cardiology cabinet
Contact Person Name
Daniel Trendafilov
Contact Person Email
trendy@abv.bg
Site Name
ASOMHIDC - Individual practice "Cardio Tonus" EOOD
Contact Person Name
Ivaylo Ivanov
Contact Person Email
ivaylo_p_ivanov@abv.bg
Site Name
Medical Center Hera EOOD
Contact Person Name
Ralitsa Pancheva
Site Name
Medical Center New Polyclinic Gabrovo Ltd.
Contact Person Name
Miroslav Stoyanov
Contact Person Email
dr.miroslav.stoyanov@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
505
Number Of Sites
5
Number Of Participants
55

Sites

Site Name
Klinische Forschung Dresden GmbH
Department Name
Klinische Forschung Dresden
Contact Person Name
Peter Heymer
Contact Person Email
peter.heymer@pratia.com
Site Name
Medizinisches Versorgungszentrum Jung GbR
Department Name
MVZ Jung GbR
Contact Person Name
Thomas Jung
Contact Person Email
dr.thomas.jung@drs-jung.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Universitätsklinikum Leipzig Klinik und Poliklinik für Kardiologie
Contact Person Name
Ulrike Rudolph
Site Name
Herzzentrum Leipzig GmbH
Department Name
Herzzentrum Leipzig GmbH
Contact Person Name
Karl Fengler
Site Name
FutureMeds GmbH
Department Name
FutureMeds GmbH
Contact Person Name
Saskia Christine Kerschischnik

Netherlands

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
612
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Internal Medicine
Contact Person Name
Liffert Vogt
Contact Person Email
l.vogt@amc.nl

Poland

Earliest CTIS Part Ii Submission Date
01-08-2024
Latest Decision Or Authorization Date
31-03-2026
Processing Time Days
607
Number Of Sites
6
Number Of Participants
45

Sites

Site Name
Velocity Nova Sp. z o.o.
Department Name
.
Contact Person Name
Grzegorz Kania
Contact Person Email
grzegorz.kania@gmail.com
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Department Name
.
Contact Person Name
Maciej Podziewski
Contact Person Email
tomaszpesta@etykaosrodek.pl
Site Name
Futuremeds Sp. z o.o. (Olsztyn)
Department Name
.
Contact Person Name
Maciej Żechowicz
Site Name
Futuremeds Sp. z o.o. (Lodz)
Department Name
.
Contact Person Name
Katarzyna Bartnicka-Masłowska
Site Name
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Nefrologii, Transplantologii i Chorób Wewnętrznych
Contact Person Name
Andrzej Więcek
Contact Person Email
awiecek@sum.edu.pl
Site Name
Etg Warszawa Sp. z o.o.
Department Name
.
Contact Person Name
Grzegorz Skoczylas
Contact Person Email
g.skoczylas@etg.network.com

Italy

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
617
Number Of Sites
5
Number Of Participants
85

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento di Scienze Mediche e Chirurgiche
Contact Person Name
Arrigo Francesco Giuseppe Cicero
Contact Person Email
arrigo.cicero@unibo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Nephrology Dpt
Contact Person Name
Francesca Chiara Viazzi
Contact Person Email
francesca.viazzi@unige.it
Site Name
University Hospital Of Ferrara
Department Name
Cardiology Department
Contact Person Name
Paolo Cimaglia
Contact Person Email
paolo.cimaglia@ospfe.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Department of Clinical And Experimental Medicine
Contact Person Name
Egidio Imbalzano
Contact Person Email
egidio.imbalzano@unime.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Division of Cardiology, Department of Clinical and Molecular Medicine
Contact Person Name
Giuliano Tocci
Contact Person Email
gtocci@ospedalesantandrea.it

Sponsor

Primary sponsor

Full Name
Mineralys Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Clinipace Inc.
Responsibilities
[{"id":991990,"code":"1"},{"id":991991,"code":"11"},{"id":991992,"code":"12"},{"id":991993,"code":"13"},{"id":991994,"code":"2"},{"id":991995,"code":"5"},{"id":991996,"code":"7"},{"id":991997,"code":"8"}]
Name
Medidata Solutions Inc.
Responsibilities
[{"id":991988,"code":"6"}]
Name
Cytel Inc.
Responsibilities
[{"id":992001,"code":"10"}]
Name
Pro-Ficiency LLC
Responsibilities
Learning Management System

Third parties

  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"[{\"id\":991989,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pro-Ficiency LLC","duties_or_roles":"Learning Management System","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"[{\"id\":991990,\"code\":\"1\"},{\"id\":991991,\"code\":\"11\"},{\"id\":991992,\"code\":\"12\"},{\"id\":991993,\"code\":\"13\"},{\"id\":991994,\"code\":\"2\"},{\"id\":991995,\"code\":\"5\"},{\"id\":991996,\"code\":\"7\"},{\"id\":991997,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"id\":991988,\"code\":\"6\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Aicure LLC","duties_or_roles":"dosing compliance","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"[{\"id\":992001,\"code\":\"10\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Concierge/Travel","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"'Automated Office Blood Pressure' reading (AOBP reading)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Myonex GmbH","duties_or_roles":"[{\"id\":991999,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Lorundrostat
Active Substance
LORUNDROSTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Starting Dose
50 mg QD (or 25 mg QD if blinded treatment dose was permanently reduced in the parent study)
Dose Levels
25 mg; 50 mg; up to 100 mg/day
Frequency
Once daily (QD)
Maximum Dose
100 mg/day
Investigational Product Name
Lorundrostat Placebo tablet
Modality
Other
Investigational Product Name
Synacthen 0,25 mg/ml Injektionslösung
Active Substance
TETRACOSACTIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INJECTION
Route
Injection (solution for injection)
Authorisation Status
Authorised (marketingAuthNumber: BE051222)
Starting Dose
0.25 mg/ml (product maximum daily amount: 0.25 mg/ml as listed)
Dose Levels
0.25 mg/ml
Maximum Dose
0.25 mg/ml
Combination Treatment
Yes

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