Clinical trial • Phase III • Gastroenterology

RESMETIROM for Non-alcoholic steatohepatitis (NASH) | Liver fibrosis

Phase III trial of RESMETIROM for Non-alcoholic steatohepatitis (NASH) | Liver fibrosis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Non-alcoholic steatohepatitis (NASH) | Liver fibrosis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-03-2024
First CTIS Authorization Date
22-04-2024

Trial design

Randomised, open-label, matching placebo (matching placebo mgl-3196 60 mg, 80 mg, 100 mg film-coated tablets) administered orally once daily in the morning to match active arms.-controlled, adaptive Phase III trial in Poland, Belgium, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Matching placebo (Matching placebo MGL-3196 60 mg, 80 mg, 100 mg film-coated tablets) administered orally once daily in the morning to match active arms.
Adaptive
True - protocol includes dose adjustment rules (in the double-blind phase doses in active arms may be decreased by 20 mg at Week 12; OLE dosing adjustments based on body weight and Week 2 drug exposure; adjudication rules trigger discontinuation from main study and entry to open-label treatment).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
1315
Trial Duration For Participant
1620

Eligibility

Recruits 1315 Vulnerable population flag is selected. All participants must provide written informed consent (see Inclusion #1). Only adults (≥18 years) are eligible; assent for minors is not applicable. Separate informed consent documentation and addenda are provided for the open-label extension (OLE)..

Pregnancy Exclusion
Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test, are not breastfeeding, and do not plan to become pregnant during the study and agree to use 2 highly effective birth control methods (HEBCM) during the study and for at least 30 days after study drug administration OR if they are not of child bearing potential. A woman is considered of childbearing potential (WOCP) i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal (PM) state is defined as no menses for 12 months without an alternative medical cause. A high folicle stimulating hormone (FSH) level in the PM range may be used to confirm PM state in women not using hormonal contraception (HC) or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. HEBCM include: Combined (and progestogen containing HC associated with inhibition of ovulation: oral, intravaginal, transdermal; Progestogen-only HC associated with inhibition of ovulation: oral, injectable, implantable; Intrauterine device); Intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner provided that the partner is the sole sexual partner of the trial participant, and that the partner has received medical assessment of the surgical process; Sexual abstinence
Vulnerable Population
Vulnerable population flag is selected. All participants must provide written informed consent (see Inclusion #1). Only adults (≥18 years) are eligible; assent for minors is not applicable. Separate informed consent documentation and addenda are provided for the open-label extension (OLE).

Inclusion criteria

  • {"criterion_text":"- Must be willing to participate in the study and provide written informed consent\n- Male and female adults ≥18 years of age.\n- Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test, are not breastfeeding, and do not plan to become pregnant during the study and agree to use 2 highly effective birth control methods (HEBCM) during the study and for at least 30 days after study drug administration OR if they are not of child bearing potential. A woman is considered of childbearing potential (WOCP) i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal (PM) state is defined as no menses for 12 months without an alternative medical cause. A high folicle stimulating hormone (FSH) level in the PM range may be used to confirm PM state in women not using hormonal contraception (HC) or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. HEBCM include: Combined (and progestogen containing HC associated with inhibition of ovulation: oral, intravaginal, transdermal; Progestogen-only HC associated with inhibition of ovulation: oral, injectable, implantable; Intrauterine device); Intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner provided that the partner is the sole sexual partner of the trial participant, and that the partner has received medical assessment of the surgical process; Sexual abstinence\n- Male subjects who are sexually active with a partner of child-bearing potential must either be sterile; practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator from the time of Screening until 30 days after the last dose of study drug administration. Male subjects must agree not to donate sperm for a period of 30 days after the last dose of study drug administration.\n- Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NASH liver fibrosis: • Historical biochemical test for fibrosis: PRO-C3 >14 ng/mL; or ELF ≥ 9 • FibroScan with transient elastography ≥8.5 kPa; and controlled attenuation parameter ≥280 dB.m-1. • Historical liver biopsy obtained <2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH based on existing pathology review, with no significant change in body weight >5% or medication that might affect NAS or fibrosis stage. NOTE: A biopsy that was obtained >6 months before the time of anticipated randomization is not eligible for study entry; a biopsy ≤6 months is potentially eligible for study entry as a baseline biopsy only after confirmation of eligibility based on Inclusion #7 by the central pathology reviewer. NOTE: Eligibility based on meeting Inclusion #5 should be determined based on historic medical and laboratory (PRO-C3/ELF, FibroScan, liver biopsy) data and should be determined prior to informed consent and screening visit.\n- MRI-PDFF fat fraction ≥8% obtained during the screening period (baseline MRI-PDFF). NOTE: To be eligible to perform the screening MRI-PDFF (Baseline MRI-PDFF) a patient must first meet Criterion #5. An eligible MRI-PDFF with fat fraction ≥8% must be obtained prior to performing the baseline liver biopsy (Criterion #7).\n- Inclusion criteria for OLE phase: 1. Patients must be willing to participate in the OLE phase and provide written informed consent.\n- Inclusion criteria for OLE phase: 2. Completed all protocol-specified visits in the Main Study and had the scheduled second liver biopsy at Month 54"}

Exclusion criteria

  • {"criterion_text":"- Regular use of drugs historically associated with NAFLD, which include but are not limited to the following: amiodarone, methotrexate, systemic oral glucocorticoids, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids except testosterone replacement, valproic acid, and known hepatotoxins for more than 4 weeks within the last 8 weeks prior to the initial Screening\n- Chronic liver diseases: a.Primary biliary cholangitis b.Primary sclerosing cholangitis c.Hepatitis B positive d.Hepatitis C as defined by presence of hepatitis C virus (HCV) antibody (HCV Ab) and positive HCV RNA (tested for known cured HCV infection, or positive HCV Ab at Screening). NOTE: Patients who are HCV antibody positive and HCV RNA negative who have a history of clearly documented HCV infection (history of positive HCV RNA) are eligible to participate if prior treatment for HCV was given, and they have a documented sustained virologic response (SVR) of at least two years prior to the baseline liver biopsy e.History or evidence of current active autoimmune hepatitis f.History or evidence of Wilson's disease g.History or evidence of alpha-1-antitrypsin deficiency h.Evidence of genetic hemochromatosis (hereditary, primary) i.Evidence of drug-induced liver disease, as defined on the basis of typical exposure and history j.Known bile duct obstruction k.Suspected or proven liver cancer.\n- Serum ALT >250 U/L NOTE:Given the intrinsic variability in ALT and AST in NASH patients, investigators should use the following guide in an attempt to establish a relatively stable baseline for ALT and AST. Investigator discretion is allowed. Documented historical (3 weeks to ≤ 6 months prior to study entry) ALT and AST levels consistent with the Screening ALT and AST values may help establish a stable baseline\n- Statins and/or other lipid-lowering therapies unless dose(s) is stable for ≥30 days prior to anticipated randomization. Statins must be taken in the evening for at least 2 weeks prior to randomization, and permitted statins include rosuvastatin up to 20 mg/day, atorvastatin up to 40 mg/day, pravastatin up to 40 mg/day, simvastatin up to 20 mg/day, pitavastatin up to 2 mg/day and lovastatin up to 40 mg/day. Other stable dyslipidemia therapies not specifically listed as excluded or dose-restricted such as PCSK9 inhibitors are allowed. Higher doses and other statins are excluded. Stable doses of bile acid sequestrants are permitted only if taken 4 h after or 4 h before the study drug dose.\n- Exclusion criterion for the OLE: 1. Any condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.\n- Pioglitazone >15 mg per day, stable treatment for ≥24 weeks prior to the eligible liver biopsy.\n- Platelet count <140,000/mm3. Patients with platelets <140,000 and ≥120,000 /mm3 are eligible if Fib-4<3.5\n- Uncontrolled cardiac arrhythmia.\n- History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study\n- Weight gain or loss ≥5% total body weight within 12 weeks prior to randomization\n- Glucagon-like peptide 1 [GLP-1] agonist therapy (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide) unless stable dose for 24 weeks prior to biopsy. NOTE: GLP-1 therapeutics may not be initiated or doses increased during the first 52 weeks of the study\n- Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis\n- Diagnosis of hepatocellular carcinoma (HCC)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Week 52 Dual Primary endpoints: NASH Resolution Response at Week 52 Fibrosis ≥ 1 Stage Responder at Week 52","definition_or_measurement_approach":"NASH Resolution: resolution of NASH associated with an at least 2-point reduction in NAFLD activity score (NAS) and without worsening of fibrosis by liver biopsy at Week 52. Resolution includes absence of ballooning (score = 0) and absent or mild lobular inflammation (score 0 to 1) associated with ≥2-point reduction in NAS. No worsening of fibrosis is defined as any progression ≥1 stage. Fibrosis ≥1 Stage Responder: histological improvement from Baseline demonstrated by at least a 1-point improvement in fibrosis by liver biopsy with no worsening of NAS at Week 52."}
  • {"endpoint_text":"- Time to Composite Clinical Outcome Event at Month 54","definition_or_measurement_approach":"Time from randomization to experiencing an adjudicated Composite Clinical Outcome event as assessed through Month 54; suspected liver-related events are reviewed by a blinded Event Adjudication Committee (EAC)."}

Secondary endpoints

  • {"endpoint_text":"- Percent change from baseline in directly measured LDL-C at Week 24 and Week 52","definition_or_measurement_approach":"Percent change from Baseline in directly measured low-density lipoprotein cholesterol (LDL-C) at Week 24 and Week 52."}

Recruitment

Planned Sample Size
1315
Recruitment Window Months
112
Consent Approach
Written informed consent is required from each participant (Inclusion #1). Participants are adults (≥18 years). Separate informed consent forms/addenda are provided for pre-screening, main study, partner/pregnancy information, OLE addendum and optional genetic testing. Consent documentation is available in multiple country/language versions as evidenced by submitted ICF documents (examples include German, Spanish, Italian, Polish, Hungarian, French, Dutch) and country-specific ICFs and addenda; participants who enter the OLE must sign an ICF specific to the OLE.

Geography

Total Number Of Sites
74
Total Number Of Participants
444

Poland

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
15
Number Of Sites
8
Number Of Participants
92

Sites

Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Katowicach
Contact Person Name
Małgorzata Sipińska-Surzyńska
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Warszawie
Contact Person Name
Magdalena Woroszył
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Łodzi
Contact Person Name
Marcin Ojrzanowski
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Poznaniu
Contact Person Name
Elżbieta Kołodziejska
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Gdyni
Contact Person Name
Anna Orkwiszewska-Nalewajko
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział we Wrocławiu
Contact Person Name
Katarzyna Szymkowiak
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Częstochowie
Contact Person Name
Jarosław Ziemba
Contact Person Email
jaroslaw.ziemba@globalaes.com
Site Name
Synexus Polska Sp. z o.o.
Department Name
Synexus Polska Oddział w Gdańsku
Contact Person Name
Milena Kowalewska-Celejewska

Belgium

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
17
Number Of Sites
9
Number Of Participants
43

Sites

Site Name
UZ Leuven
Department Name
Liver and biliopancreatic disorders
Contact Person Name
Wim Laleman
Contact Person Email
wim.laleman@uzleuven.be
Site Name
Az Maria Middelares Gent
Department Name
Gastroenterology and hepatology
Contact Person Name
Christophe Van Steenkiste
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hepatogastroenterology
Contact Person Name
Nicolas Lanthier
Contact Person Email
nicolas.lanthier@uclouvain.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Gastroenterology and hepatology
Contact Person Name
Mathieu Struyve
Contact Person Email
mathieu.struyve@zol.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Hepatology and Gastroenterology
Contact Person Name
Anja Geerts
Contact Person Email
anja.geerts@ugent.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Department of Gastroenterology/Hepatology
Contact Person Name
Jochen Decaestecker
Contact Person Email
jochen.decaestecker@azdelta.be
Site Name
Antwerp University Hospital
Department Name
Gastroenterology and hepatology
Contact Person Name
Sven Francque
Contact Person Email
sven.francque@uza.be
Site Name
Hopital Erasme
Department Name
Department of Gastroenterology/Hepatopancreotology
Contact Person Name
Christophe Moreno
Site Name
Chu Brugmann
Department Name
Gastro enteroloy department
Contact Person Name
Luc Lasser
Contact Person Email
luc.lasser@chu-brugmann.be

Austria

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
26-04-2024
Processing Time Days
17
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Gastroenterologie und Hepatologie, Rheumatologie, Endokrinologie und Diabetologie
Contact Person Name
Harald Hofer
Contact Person Email
harald.hofer@klinikum-wegr.at
Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Abteilung für Innere Medizin und Gastroenterologie
Contact Person Name
Markus Peck-Radosavljevic
Contact Person Email
markus@peck.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Interne 4 - Gastroenterologie & Hepatologie, Stoffwechsel- & Ernährungsmedizin, Endokrinologie
Contact Person Name
Alexander Lindorfer
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Klinische Abteilung für Innere Medizin 2
Contact Person Name
Andreas Maieron

Germany

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
08-05-2024
Processing Time Days
29
Number Of Sites
11
Number Of Participants
69

Sites

Site Name
Synexus Clinical Research GmbH
Department Name
Synexus Berlin Clinical Research
Contact Person Name
Konrad Janik
Contact Person Email
konrad.janik@globalaes.com
Site Name
Eugastro GmbH
Department Name
Gastroenterology and Hepatology
Contact Person Name
Ingolf Schiefke
Contact Person Email
studien@eugastro.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinischen Poliklinik
Contact Person Name
Ulrike Morgera
Contact Person Email
ulrike.morgera@charite.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II, Schwerpunkt Hepatologie
Contact Person Name
Andreas Geier
Contact Person Email
geier_a2@ukw.de
Site Name
Synexus Clinical Research GmbH
Department Name
Synexus Leipzig Clinical Research
Contact Person Name
Angelika Bold
Contact Person Email
angelika.bold@globalaes.com
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Contact Person Name
Jörn M. Schattenberg
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Contact Person Name
Münevver Demir
Contact Person Email
muenevver.demir@charite.de
Site Name
Synexus Clinical Research GmbH
Department Name
Synexus Frankfurt Clinical Research
Contact Person Name
Christel Contzen
Contact Person Email
christel.contzen@globalaes.com
Site Name
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Contact Person Name
Keikawus Arastéh
Contact Person Email
keikawus.arasteh@epimed.org
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Contact Person Name
Anita Pathil-Warth
Contact Person Email
pathilwa@med.uni-frankfurt.de
Site Name
Velocity Clinical Research Germany GmbH
Department Name
Velocity Clinical Research Germany GmbH, Location Leipzig
Contact Person Name
Roland Kuchta
Contact Person Email
rkuchta@velocityclinical.com

Spain

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
13
Number Of Sites
11
Number Of Participants
38

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Gastroenterology Unit
Contact Person Name
Agustin Albillos Martinez
Contact Person Email
agustin.albillos@uah.es
Site Name
Complexo Hospitalario Universitario De Pontevedra
Contact Person Name
Juan Turnes Vazquez
Contact Person Email
juan.turnes.vazquez@sergas.es
Site Name
CEIM Del Consorcio Hospital General Universitario De Valencia
Department Name
Digestive Pathology Department
Contact Person Name
Mercedes Latorre Sanchez
Contact Person Email
mercedeslatorre@msn.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Digestive Department
Contact Person Name
Paula Iruzubieta Coz
Contact Person Email
paula.irzubieta@scsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology Unit
Contact Person Name
Manuel Romero Gomez
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Gastroenterology Unit
Contact Person Name
Jose Luis Calleja Panero
Contact Person Email
jlcallejap@gmail.com
Site Name
Hospital Del Mar
Department Name
Gastroenterology Unit
Contact Person Name
Montserrat Garcia Retortillo
Contact Person Email
97235@parcdesalutmar.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hepatology and Liver Transplant Unit
Contact Person Name
Luis Ibañez Samaniego
Contact Person Email
lisamaniego@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hepato -gastroenterology Unit
Contact Person Name
Isabel Conde Amiel
Contact Person Email
icondeamiel@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Liver Unit
Contact Person Name
Juan Manuel Pericas
Contact Person Email
jpericas@vhebron.net
Site Name
Hospital Universitario Torrecardenas
Department Name
Hepatology Unit
Contact Person Name
Marta Casado Martin
Contact Person Email
mm.casado.m@gmail.com

Hungary

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
24-04-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
44

Sites

Site Name
University Of Debrecen
Department Name
Kenezy Gyula Egyetemi Korhaz,Infektologiai Intezet, Farmakologiai Reszleg
Contact Person Name
Istvan Zsolt Varkonyi
Site Name
Trial Pharma Kft.
Contact Person Name
Tivadar Banyai
Contact Person Email
banyai.tivadar@bmkk.eu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Infektologia
Contact Person Name
Viktoria Czuczor
Contact Person Email
bvpassat@freemail.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Viktor Vass
Contact Person Email
viktor.vass@oec.hu

France

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
06-05-2024
Processing Time Days
27
Number Of Sites
17
Number Of Participants
113

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service d'Hépato-gastroentérologie
Contact Person Name
Jerome Boursier
Contact Person Email
jeboursier@chu-angers.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service D'Hepato-Gastro-Entérologie
Contact Person Name
Anne Varaut
Contact Person Email
anne.varaut@hotmail.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Recherche Hépatologie
Contact Person Name
Christophe Bureau
Contact Person Email
bureau.c@chu-toulouse.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service Hépato-Gastro Entérologie et d’assistance nutritive
Contact Person Name
François Habersetzer
Site Name
University Hospitals Pitie Salpetriere Charles Foix
Department Name
Service d'Hépatogastroentérologie
Contact Person Name
Vlad Ratziu
Contact Person Email
vlad.ratziu@inserm.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service des Maladies du Foie
Contact Person Name
Edouard Bardou-Jacquet
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pôle Hépato-Digestif
Contact Person Name
Lawrence Serfaty
Site Name
Hopital Beaujon
Department Name
Département d'Hépatologie
Contact Person Name
Laurent Castera
Contact Person Email
laurent.castera@aphp.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
service Hépato-Gatroentérologie
Contact Person Name
Rémi Collin
Contact Person Email
remi.collin@chulimoges.fr
Site Name
Hopital De La Croix Rousse
Department Name
Service d'Hépato Gastro Entérologie
Contact Person Name
Marianne Maynard-Muet
Site Name
Hopital Cochin Saint Vincent De Paul
Department Name
Service Hepatologie Médicale
Contact Person Name
Lucia Parlati
Contact Person Email
lucia.parlati@aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Médecine Digestive et Hépatobiliaire
Contact Person Name
Armando Abergel
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies de l’Appareil Digestif et de la Nutrition
Contact Person Name
Philippe Mathurin
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pôle de Référence Hépato Gastro-entérologie et Oncologie Digestive
Contact Person Name
Albert Tran
Contact Person Email
tran.a@chu-nice.fr
Site Name
Besancon University Hospital Center
Department Name
Service d'Hépathologie
Contact Person Name
Vincent Di Martino
Contact Person Email
vdimartino@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d’Hépato-gastroentérologie et Transplantation
Contact Person Name
Stephanie Faure
Contact Person Email
s-faure@chu-montpellier.fr
Site Name
CHRU De Nancy
Department Name
Service Hépato-Gastro-Entérologie
Contact Person Name
Jean-Pierre Bronowicki
Contact Person Email
jp.bronowicki@chu-nancy.fr

Italy

Earliest CTIS Part Ii Submission Date
09-04-2024
Latest Decision Or Authorization Date
03-05-2024
Processing Time Days
24
Number Of Sites
10
Number Of Participants
39

Sites

Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
COMPLEX OPERATIONAL UNIT OF CLINICAL AND BIOMOLECULAR HEPATOLOGY
Contact Person Name
Carlo Saitta
Contact Person Email
carlo.saitta@unime.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
MEDICINA INTERNA
Contact Person Name
Francesco Baratta
Contact Person Email
francesco.baratta@uniroma1.it
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Medicina Interna
Contact Person Name
Luca Miele
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Epathology
Contact Person Name
Maurizia Rosanna Brunetto
Contact Person Email
maurizia.brunetto@unipi.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
UO Epathology
Contact Person Name
Mario Pirisi
Contact Person Email
mario.pirisi@med.unipmn.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and epathology department
Contact Person Name
Pietro Lampertico
Contact Person Email
pietro.lampertico@unimi.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
UO Epathology
Contact Person Name
Alessandra Mangia
Contact Person Email
a.mangia@tin.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Gastroenterology
Contact Person Name
Salvatore Petta
Contact Person Email
salvatore.petta@unipa.it
Site Name
Careggi University Hospital
Department Name
MEDICINA INTERNA
Contact Person Name
Fabio Marra
Contact Person Email
fabio.marra@unifi.it
Site Name
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.L
Department Name
Diabetologhy ISMETT
Contact Person Name
Alessandro Mattina
Contact Person Email
amattina@ismett.edu

Sponsor

Primary sponsor

Full Name
Madrigal Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple trial operational roles; medical image analysis / review
Name
Inotiv Inc.
Responsibilities
preparation of biopsy slides / laboratory support
Name
Suvoda LLC
Responsibilities
Drug Management
Name
Medidata Solutions

Third parties

  • {"country":"United States","full_name":"Inotiv Inc.","duties_or_roles":"preparation of biopsy slides","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Medical image analysis /review","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Liverpat","duties_or_roles":"Central pathologist; Reading biopsy slides or study analyses","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Excilone","duties_or_roles":"preparation of biopsy slides","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Drug Management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"QP Declaration and QP Certification of IMP including placebo; packing, labeling and IP management.","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Sample collection, results reporting and management of biomarkers, PK assessment","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Echosens","duties_or_roles":"Fibroscan","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/ review","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"Analytical chemistry, performs the analysis on the PRO-C3 samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Xerimis B.V.","duties_or_roles":"QP Certification of IMP including placebo; packaging, labeling and IMP management.","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MGL-3196 60 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
60 mg
Dose Levels
60 mg
Frequency
once daily in the morning
Maximum Dose
100 mg
Dose Escalation Increase
60 mg (no escalation specified for this dose arm; dose reductions permitted in higher arms)
Investigational Product Name
MGL-3196 80 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
80 mg
Dose Levels
80 mg
Frequency
once daily in the morning
Maximum Dose
100 mg
Dose Escalation Increase
80 mg (dose may be decreased by 20 mg to 60 mg at Week 12 if required)
Investigational Product Name
MGL-3196 100 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral
Route
oral
Authorisation Status
Authorised
Starting Dose
100 mg
Dose Levels
100 mg
Frequency
once daily in the morning
Maximum Dose
100 mg
Dose Escalation Increase
100 mg (dose may be decreased by 20 mg to 80 mg or to 60 mg at Week 12 if required)
Investigational Product Name
Matching placebo MGL-3196 60 mg/80 mg/100 mg film-coated tablet
Modality
Other
Routes Of Administration
Oral
Route
oral
Frequency
once daily in the morning (matching active arms)

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