Clinical trial • Phase III • Gastroenterology

RESMETIROM for Non-alcoholic steatohepatitis (NASH) cirrhosis

Phase III trial of RESMETIROM for Non-alcoholic steatohepatitis (NASH) cirrhosis.

Overview

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

Key dates

Initial CTIS Submission Date
25-06-2024
First CTIS Authorization Date
17-07-2024

Trial design

Randomised, matching placebo (matching placebo mgl-3196 80 mg, 60 mg, 100 mg film-coated tablets) administered orally once daily in the morning to match active resmetirom arms; primary allocation 3:1 resmetirom:placebo (80 mg cohort) and separate ~10% cohort randomized 3:1 to 60 mg resmetirom or matching placebo. dose adjustments possible per protocol.-controlled, adaptive Phase III trial in Belgium, France, Germany and others.

Randomised
Yes
Comparator
Matching placebo (matching placebo MGL-3196 80 mg, 60 mg, 100 mg film-coated tablets) administered orally once daily in the morning to match active resmetirom arms; primary allocation 3:1 resmetirom:placebo (80 mg cohort) and separate ~10% cohort randomized 3:1 to 60 mg resmetirom or matching placebo. Dose adjustments possible per protocol.
Adaptive
True, dose adjustments/escalation rules are specified: for the 80 mg cohort dose adjustments possible (increase from 80 mg to 100 mg or decrease from 80 mg to 60 mg) based on predefined criteria; for the ~10% 60 mg cohort dose adjustments possible (increase from 60 mg to 80 mg or decrease from 60 mg to 40 mg). The trial is event-driven (continues until required number of events achieved).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
697
Trial Duration For Participant
1183

Eligibility

Recruits 697 Vulnerable population selected. All participants must provide written informed consent. Subject information and ICF documents are available in country-specific languages (examples in the dossier: German, French, Spanish, Italian, Dutch, English). Specific information/ICF materials are provided for pregnancy and pregnant partner scenarios and for optional pharmacogenomic testing. No paediatric consent/assent procedures are described (trial enrols adults ≥18 years)..

Pregnancy Exclusion
3. Female patients who: a. are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not parturient, not breastfeeding, and do not plan to become pregnant during the study and agree to use highly effective birth control methods during the study from Screening, throughout the study, and for at least 30 days after the last dose of study drug administration. b. OR are not of child bearing potential (ie, surgically [permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy] or naturally sterile [no menses for > 12 months without an alternative medical cause]) - Female patients must agree not to donate ovocytes for a period of 30 days after the last dose of study drug administration (France only)
Vulnerable Population
Vulnerable population selected. All participants must provide written informed consent. Subject information and ICF documents are available in country-specific languages (examples in the dossier: German, French, Spanish, Italian, Dutch, English). Specific information/ICF materials are provided for pregnancy and pregnant partner scenarios and for optional pharmacogenomic testing. No paediatric consent/assent procedures are described (trial enrols adults ≥18 years).

Inclusion criteria

  • {"criterion_text":"- 1. Must be willing to participate in the study and provide written informed consent NOTE: Subjects must be affiliated to the social security regime or be a beneficiary of such a regime. (France only)"}
  • {"criterion_text":"- 2. Male and female adults ≥18 years of age"}
  • {"criterion_text":"- 3. Female patients who: a. are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not parturient, not breastfeeding, and do not plan to become pregnant during the study and agree to use highly effective birth control methods during the study from Screening, throughout the study, and for at least 30 days after the last dose of study drug administration. b. OR are not of child bearing potential (ie, surgically [permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy] or naturally sterile [no menses for > 12 months without an alternative medical cause]) - Female patients must agree not to donate ovocytes for a period of 30 days after the last dose of study drug administration (France only)"}
  • {"criterion_text":"- 4. Male patients who are sexually active with a partner of child-bearing potential and: a. are sterile (vasectomy with history of a negative sperm count at least 90 days following the procedure) b. OR practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable) OR c. OR agree to use a birth control method during the study from the time of Screening until 30 days after the last dose of study drug administration. - Male patients must agree not to donate sperm for a period of 30 days after the last dose of study drug administration."}
  • {"criterion_text":"- 5. Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials, Noureddin 2020; Historic Biopsy, Tissue available A. On study centrally read as F4, historic biopsy is consistent with NASH cirrhosis i) Continue in screening B. On study centrally read as consistent with NASH with significant fibrosis i) Biopsy must have been obtained six months or greater prior to prescreening date (to allow time for clinical progression to occur) and patient must now be presenting with clinical cirrhosis ii) If screening FibroScan ≥ 15 kPa, must also have one of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 iii) If screening FibroScan < 15 kPa, must also have two of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 • Historic Biopsy, Tissue not available A. Historical read as F4. If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if an NAS is not provided. i) Continue in screening B. Historical read as consistent with NASH with significant fibrosis i) Biopsy must have been obtained six months or greater prior to prescreening date (to allow time for clinical progression to occur) and patient must now be presenting with clinical cirrhosis ii) If screening FibroScan ≥ 15 kPa, must also have one of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 iii) If screening FibroScan < 15 kPa, must also have two of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 per mL • No Biopsy – subject must be presenting with clinical cirrhosis i) If screening FibroScan ≥ 15 kPa, must also have one of the following results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 ii) If screening FibroScan <15 kPa, must also have two of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 • On study (not historic) biopsy (only obtained in rare instances and with preapproval from the Sponsor), or the biopsy was obtained less than six months prior to the screening date A. On study (not historic) centrally read as F4, biopsy is consistent with NASH cirrhosis i) Continue in screening B. On study centrally read as consistent with NASH with significant fibrosis i) Need screening FibroScan ≥ 15 kPa ii) Must also have all of the following screening results: (1) MRE ≥4.2 kPa (2) ELF ≥10.25 (3) Fib-4 ≥3 (4) Platelet count <140,000 mm3 − NOTE: When possible, historical biopsies that are used for eligibility will be reviewed and confirmed as consistent with NASH cirrhosis by a central pathologist − In the event of a conflicting read between historical biopsy report and central biopsy read, the central report will be used."}
  • {"criterion_text":"- 6. Well-compensated Child-Pugh A (score of 5–6) cirrhosis at Screening and Baseline AND no history of a hepatic decompensation event."}

Exclusion criteria

  • {"criterion_text":"- 1. Chronic liver diseases other than NASH cirrhosis: a. Primary biliary cholangitis b. Primary sclerosing cholangitis c. Hepatitis B positive (as defined in Appendix 2) d. Hepatitis C (as defined in Appendix 3) 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. History or 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 confirmed liver cancer"}
  • {"criterion_text":"- 10. History of biliary diversion"}
  • {"criterion_text":"- 11. Uncontrolled hypertension (either treated or untreated), defined as systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg at Screening"}
  • {"criterion_text":"- 12. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction <30%"}
  • {"criterion_text":"- 13. Uncontrolled cardiac arrhythmia"}
  • {"criterion_text":"- 14. Screening ECG shows uncontrolled cardiac arrythmia, or not previously diagnosed."}
  • {"criterion_text":"- 2. MELD score ≥12, due to liver disease at either screening OR baseline. - NOTE: MELD of ≥12 as the result of liver disease is exclusionary, NOT including isolated lab abnormalities such as elevated creatinine due to chronic kidney disease, INR abnormality secondary to anticoagulants or lab error, or bilirubin elevation due to Gilbert's syndrome. UGT1A1 allele testing to be performed at Screening on all patients (where permitted)."}
  • {"criterion_text":"- 3. History of hepatic decompensation or impairment at either screening or baseline, defined as presence of any of the following: a. History of variceal bleeding (NOTE: small to medium (Grade I-II) nonbleeding varices are allowed) b. Ascites due to cirrhosis. Screening MRI or CT shows at least a 2 cm pocket of fluid in at least 2 of 5 abdominal stations, including the four abdominal quadrants and pelvis. NOTE: in situations where both MRI and CT are contraindicated, ultrasound is acceptable for evaluation of ascites. c. Overt hepatic encephalopathy, lactulose treatment, or other treatment for hepatic encephalopathy d. Serum albumin <3.5 g/dL, except as explained by non-hepatic causes e. INR >1.4 unless due to therapeutic anticoagulants or laboratory error (NOTE: If laboratory error is suspected, retest to confirm INR ≤1.4 is required) f. Total bilirubin ≥2 mg/dL - NOTE: Patients with genetically confirmed Gilbert's syndrome are eligible with a total bilirubin ≥2 mg/dL if reticulocyte count is within normal limits, hemoglobin is within normal limits unless due to chronic anemia and unrelated to hemolysis, and direct bilirubin is <20% of total bilirubin."}
  • {"criterion_text":"- 4. Diagnosis of hepatocellular carcinoma (HCC) at Screening or historically"}
  • {"criterion_text":"- 5. Liver Imaging Reporting and Data System (LI-RADS) score ≥4 at Screening. NOTE: in situations where both MRI and CT are contraindicated, ultrasound is acceptable for evaluation of hepatocellular cancer."}
  • {"criterion_text":"- 6. Thyroid diseases, as defined by the following conditions: a. Active hyperthyroidism. - NOTE: Patients with a history of hyperthyroidism are eligible to participate. b. Untreated clinical hypothyroidism defined by: - Thyroid stimulating hormone (TSH) ≥7 IU/L with symptoms of hypothyroidism, or - TSH ≥10 IU/L without symptoms • NOTE: TSH may be repeated once during Screening, and if still does not meet entry criteria, patients will be considered screen failures. Patients with clinical hypothyroidism newly treated with thyroxine may be rescreened once thyroxine dose is stabilized."}
  • {"criterion_text":"- 7. Has an active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease, or autoimmune hepatitis that requires systemic treatment within the past 12 weeks or a documented history of clinically severe autoimmune disease, including autoimmune liver disease, or a syndrome that requires systemic steroids or immunosuppressive agents. • NOTE: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators, topical, inhaled, or intranasal corticosteroids, or local steroid injections are not excluded from the study. • NOTE: Patients with autoimmune diseases such as rheumatoid arthritis who are on systemic therapies may be eligible on a case-by-case basis as long as the systemic therapy for the autoimmune disease is not specifically excluded (ie, steroids or immunosuppressive agents)."}
  • {"criterion_text":"- 8. Alcohol consumption of any type, frequency or amount is not allowed during the Screening or Treatment phase of the study"}
  • {"criterion_text":"- 9. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the effect of once-daily, oral administration of resmetirom versus matching placebo on NASH CP-A patients, as measured by the time to a confirmed adjudicated Composite Clinical Outcome event. The composite clinical outcome event is composed of liver-related or CV mortality, liver transplant, significant hepatic events including hepatic decompensation events and confirmed increase of MELD score from <12 to ≥15.","definition_or_measurement_approach":"Time-to-event analysis measuring time to first adjudicated Composite Clinical Outcome event. The composite event is defined as liver-related or cardiovascular mortality, liver transplant, significant hepatic events including hepatic decompensation events (ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage) and confirmed increase of MELD score from <12 to ≥15. Events are adjudicated and analysis is event-driven (until required number of events achieved, ~3 years)."}

Secondary endpoints

  • {"endpoint_text":"- 1. Percent change from baseline in LDL-C at Week 28","definition_or_measurement_approach":"Percent change from baseline in low density lipoprotein cholesterol (LDL-C) measured at Week 28 compared to baseline laboratory values."}
  • {"endpoint_text":"- 2. Percent change from Baseline to Week 52 in hepatic fat fraction by MRI-PDFF in patients with baseline MRI-PDFF >=5%.","definition_or_measurement_approach":"Percent change from baseline to Week 52 in hepatic fat fraction assessed by MRI-PDFF in the subgroup of patients with baseline MRI-PDFF ≥5%."}

Recruitment

Planned Sample Size
697
Recruitment Window Months
35
Consent Approach
Written informed consent is required from all participants prior to any study procedures. Subject information sheets and ICFs are provided; country-specific ICFs are available (examples in dossier: German, French, Spanish, Italian, Dutch, English). Specific ICFs/materials exist for pregnancy, pregnant partner, and optional pharmacogenomic testing. Participants are adults (≥18) so parental consent/assent is not applicable.

Geography

Total Number Of Sites
38
Total Number Of Participants
148

Belgium

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
18-08-2025
Processing Time Days
490
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Az Maria Middelares Gent
Department Name
Gastroenterology
Contact Person Name
Christophe Van Steenkiste
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology
Contact Person Name
Anja Geerts
Contact Person Email
Anja.geerts@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Gastroenterology
Contact Person Name
Nicolas Lanthier
Contact Person Email
Nicolas.lanthier@uclouvain.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Gastroenterology
Contact Person Name
Charlotte De Vloo
Contact Person Email
Charlotte.devloo@azdelta.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Gastroenterology
Contact Person Name
Sven Francque
Contact Person Email
sven.francque@uza.be
Site Name
Hopital Erasme
Department Name
Gastroenterology
Contact Person Name
Christophe Moreno

France

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
491
Number Of Sites
12
Number Of Participants
62

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service Hepato-Gastro-Enterologie
Contact Person Name
Jerome BOURSIER
Contact Person Email
jeboursier@chu-angers.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Départemet d'Hépatologie
Contact Person Name
Vlad Ratziu
Contact Person Email
vlad.ratziu@inserm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Departement d'Hepatologie
Contact Person Name
Anne-Cecile VARAUT
Contact Person Email
anne.varaut@aphp.fr
Site Name
Hopital Paul Brousse
Department Name
Centre Hepato-Biliaire
Contact Person Name
Audrey COILLY
Contact Person Email
audrey.coilly@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d hepatologie
Contact Person Name
Christophe BUREAU
Contact Person Email
bureau.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pole de Reference Hepato Gastro-enterologie et Oncologie Digestive – niveau 5A
Contact Person Name
Albert TRAN
Contact Person Email
tran.a@chu-nice.fr
Site Name
Hopital Beaujon
Department Name
Service d'Hépatologie
Contact Person Name
Laurent Castera
Contact Person Email
laurent.castera@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies de l Appareil Digestif et de la Nutrition (MADN), 1er etage aile Est
Contact Person Name
Philippe MATHURIN
Contact Person Email
philippe.mathurin@chu-lille.fr
Site Name
Hopital De La Croix-Rousse
Department Name
Service d'Hépato Gastro Entérologie
Contact Person Name
Marianne Maynard-Muet
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service Hepato-gastroenterologie
Contact Person Name
Lawrence SERFATY
Site Name
CHRU De Nancy
Department Name
Service Hépato-Gastro-Entérologie
Contact Person Name
Jean-Pierre Bronowicki
Contact Person Email
jp.bronowicki@chru-nancy.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Medicine Digestive et Hepatobiliaire
Contact Person Name
Armando ABERGEL

Germany

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
492
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Innere Medizin II
Contact Person Name
Jörn Schattenberg
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Section of Hepatology
Contact Person Name
Johannes Wiegand
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
CVK Medizinische Klinik m. S. Hepatologie und Gastroenterologie
Contact Person Name
Münevver Demir
Contact Person Email
muenevver.demir@charite.de
Site Name
Eugastro GmbH
Department Name
Gastroenterology and Hepatology
Contact Person Name
Ingolf Schiefke
Contact Person Email
Ingolf.Schiefke@eugastro.de

Italy

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
491
Number Of Sites
8
Number Of Participants
29

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Department of Gastroenterology
Contact Person Name
Elisabetta Bugianesi
Contact Person Email
elisabetta.bugianesi@unito.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and Hepatology Division
Contact Person Name
Pietro Lampertico
Contact Person Email
pietro.lampertico@unimi.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Hepatology Department
Contact Person Name
Alessandra Mangia
Contact Person Email
a.mangia@tin.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Department of Internal medicine and Hepatology
Contact Person Name
Alessio Aghemo
Contact Person Email
alessio.aghemo@hunimed.eu
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and Clinical Medicine
Contact Person Name
Fabio Marra
Contact Person Email
fabio.marra@unifi.it
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Dpt Scienze Mediche e Chirurgiche
Contact Person Name
Luca Miele
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
Diabetic and pancreatic transplantation unit
Contact Person Name
Alessandro Mattina
Contact Person Email
amattina@ismett.edu
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Hepatology Department
Contact Person Name
Maurizia Rossana Brunetto
Contact Person Email
maurizia.brunetto@unipi.it

Spain

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
491
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Gastroenterology and Hepatology
Contact Person Name
Isabel Conde Amiel
Contact Person Email
icondemiel@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Gastroenterology
Contact Person Name
Rocio Aller de la Fuente
Contact Person Email
rallerf@saludcastillayleon.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Liver Unit
Contact Person Name
Juan Manuel Pericas
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Gastroenterology and Hepatology
Contact Person Name
Jose Luis Calleja Panero
Contact Person Email
jlcallejap@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Hepatology and Liver transplantation
Contact Person Name
Antonio Olveira Martín
Contact Person Email
aolveiram@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Liver transplantation
Contact Person Name
Pere Ginés Gibert
Contact Person Email
pgines@clinic.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology Unit
Contact Person Name
Manuel Romero Gómez
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hepatology and Liver transplantation
Contact Person Name
Luis Ibañez Samaniego
Contact Person Email
luisamaniego@gmail.com

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
Trial Master file maintenance; Medical image analysis/review - MRI-PDFF, MRE, MRI, Ultrasound, etc.; multiple operational roles
Name
Syneos Health Inc.
Responsibilities
Operational CRO responsibilities (codes: 10;5;6;7)
Name
Suvoda LLC
Responsibilities
eClinical services (code 3)
Name
WCG Clinical Inc.
Responsibilities
EAC and DMC services
Name
Summit Clinical Research LLC
Responsibilities
Site management organization

Third parties

  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"code 14; EU QP release","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Xerimis B.V.","duties_or_roles":"QP certification of IMP including placebo; packaging, labelling and IMP management.","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":"United States","full_name":"Inotiv Inc.","duties_or_roles":"Biopsy slide processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Summit Clinical Research LLC","duties_or_roles":"Site management organization","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Echosens","duties_or_roles":"Fibroscan","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes: 10;5;6;7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Trial Master file maintenance; Medical image analysis/review - MRI-PDFF, MRE, MRI, Ultrasound, etc.; codes: 1;12;13;15;2;5;8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"EAC and DMC services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Duke Clinical Research Institute","duties_or_roles":"Imaging central reader","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Excilone","duties_or_roles":"Digitalization and management of biopsy slides","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO Device for QoLs; codes: 6;7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Liverpat","duties_or_roles":"Central reader for interpretation of biopsy slides","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"ECG analysis/ review","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Novasco","duties_or_roles":"Patient Reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Clinical chemistry; Clinical haematology; code 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
MGL-3196 100 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
Authorised
Starting Dose
100 mg
Dose Levels
100 mg
Frequency
Once daily (morning)
Maximum Dose
100 mg
Dose Escalation Increase
Initial 100 mg (no higher escalation specified); for 80 mg cohort the protocol allows increase to 100 mg.
Investigational Product Name
MGL-3196 80 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
Authorised
Starting Dose
80 mg
Dose Levels
60 mg, 80 mg, 100 mg
Frequency
Once daily (morning)
Maximum Dose
100 mg
Dose Escalation Increase
Initial 80 mg -> may be increased to 100 mg or decreased to 60 mg based on protocol criteria
Investigational Product Name
MGL-3196 60 mg oral
Active Substance
RESMETIROM
Modality
Small molecule
Routes Of Administration
Oral use
Route
Oral
Authorisation Status
Authorised
Starting Dose
60 mg
Dose Levels
40 mg, 60 mg, 80 mg
Frequency
Once daily (morning)
Maximum Dose
80 mg
Dose Escalation Increase
Initial 60 mg -> may be increased to 80 mg or decreased to 40 mg based on protocol criteria

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