MAESTRO-NASH: A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Study Details
Study Description
Brief Summary
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Matching Placebo Placebo Daily |
Drug: Placebo
Matching Tablets
|
Active Comparator: 80 mg MGL-3196 80 mg daily |
Drug: MGL-3196
Tablet
Other Names:
|
Active Comparator: 100 mg MGL-3196 100 mg daily |
Drug: MGL-3196
Tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis [Measurements at Baseline and 52 weeks]
Assessment will be in the first 900 patients, at least 450 F3, and be based on the proportion of MGL-3196 80 mg or 100 mg treated patients relative to placebo achieving NASH resolution (NASH Activity Score (NAS), ballooning =0; lobular inflammation =0,1) with at least a 2 point reduction in NAS and no worsening of fibrosis.
- Composite long-term outcome events composed of all-cause mortality, cirrhosis, and other significant liver-related events [Time frame to accrue a prespecified number of adjudicated events; up to 54 months]
To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo on composite long-term outcome measured by the number of patients with the onset of any of the adjudicated events, composed of cirrhosis, all-cause mortality and liver-related clinical outcomes.
Secondary Outcome Measures
- To determine the effect of once-daily, oral administration of MGL-3196 80 or 100 mg versus matching placebo on the percent change from Baseline at 24 weeks in low-density lipoprotein cholesterol (LDL-C) [Measurements at Baseline and 24 weeks]
Assess the effect of MGL-3196 80 mg or 100 mg compared to placebo on LDL-C measured by percent change from Baseline at 24 weeks.
- To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve improvement in fibrosis on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis [Measurements at Baseline and 52 weeks]
Assessment will be in the first 900 patients, at least 450 F3, and be based on the proportion of MGL-3196 80 mg or 100 mg treated patients relative to placebo achieving at least a 1-point improvement in fibrosis (NASH Clinical Research Network system) by liver biopsy with no worsening of NAS.
Other Outcome Measures
- To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with Stage 1 fibrosis [Measurements at Baseline and 52 weeks]
Assessment will be in Stage 1 fibrosis patients and be based on the proportion of MGL-3196 80 mg or 100 mg treated patients relative to placebo achieving NASH resolution (NASH Activity Score (NAS), ballooning =0; lobular inflammation =0,1) with at least a 2 point reduction in NAS and no worsening of fibrosis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must be willing to participate in the study and provide written informed consent.
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Male and female adults ≥ 18 years of age.
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Suspected or confirmed diagnosis of NASH
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Metabolic risk factors and AST > 20 U/L
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Criteria consistent with liver fibrosis as defined as one of the following:
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Biochemical test for fibrosis OR
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Fibroscan test OR
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Historical liver biopsy with diagnosis of NASH with fibrosis Stage 2 or 3
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MRI-PDFF with increased fat fraction
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Biopsy-proven NASH (Baseline liver biopsy) based on a liver biopsy obtained within 24 weeks before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A, 1B, 2, or 3 on liver biopsy and NAS of ≥ 4 with a score of at least 1 in each of the following NAS components:
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Steatosis (scored 0 to 3)
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Ballooning degeneration (scored 0 to 2)
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Lobular inflammation (scored 0 to 3)
Exclusion Criteria:
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History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
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Regular use of drugs historically associated with NAFLD
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History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
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Recent significant weight gain or loss
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HbA1c ≥ 9.0%.
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Glucagon-like peptide 1 [GLP-1] agonist , high dose Vitamin E (> 400 IU/day) or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
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Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
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Diagnosis of hepatocellular carcinoma (HCC).
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MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
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Hepatic decompensation
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Chronic liver diseases other than NASH
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Active autoimmune disease
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Serum ALT > 250 U/L.
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Active, serious medical disease with a likely life expectancy < 2 years.
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Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
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Any other 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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | East Valley Family Physicians | Chandler | Arizona | United States | 85224 |
2 | The Institute for Liver Health - Chandler | Chandler | Arizona | United States | 85224 |
3 | The Institute for Liver Health - Glendale | Glendale | Arizona | United States | 85306 |
4 | Desert Clinical Research | Mesa | Arizona | United States | 85213 |
5 | Adobe Gastroenterology | Tucson | Arizona | United States | 85712 |
6 | The Institute for Liver Health - Tucson | Tucson | Arizona | United States | 85712 |
7 | Arkansas Gastroenterology | North Little Rock | Arkansas | United States | 72117 |
8 | Fresno Clinical Research Center | Fresno | California | United States | 93720 |
9 | National Research Institute - Huntington Park | Huntington Park | California | United States | 90255 |
10 | University of California San Diego | La Jolla | California | United States | 92037 |
11 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
12 | National Research Institute - Los Angeles | Los Angeles | California | United States | 90057 |
13 | Ruane Clinical Research | Los Angeles | California | United States | 90057 |
14 | National Research Institute - Panorama City | Panorama City | California | United States | 91402 |
15 | Alliance Clinical Research | Poway | California | United States | 92064 |
16 | San Fernando Valley Health Institute | Van Nuys | California | United States | 91405 |
17 | Colorado Springs Family Practice | Colorado Springs | Colorado | United States | 80909 |
18 | South Denver Gastroenterology - Swedish Medical Center Office | Englewood | Colorado | United States | 80113 |
19 | Excel Medical Clinical Trials | Boca Raton | Florida | United States | 33434 |
20 | University of Florida Hepatology Research at CTRB | Gainesville | Florida | United States | 32610 |
21 | Nature Coast Clinical Research | Inverness | Florida | United States | 34452 |
22 | Florida Research Institute | Lakewood Ranch | Florida | United States | 34211 |
23 | Miami Dade Medical Research Institute | Miami | Florida | United States | 33176 |
24 | Bioclinica Research - Orlando | Orlando | Florida | United States | 32806 |
25 | Progressive Medical Research | Port Orange | Florida | United States | 32127 |
26 | Covenant Research | Sarasota | Florida | United States | 34240 |
27 | Bioclinica Research - The Villages | The Villages | Florida | United States | 32162 |
28 | GI Specialists of Georgia | Marietta | Georgia | United States | 30060 |
29 | Clinical Research - Chicago | Chicago | Illinois | United States | 60602 |
30 | Northwestern Medical Faculty Foundation | Chicago | Illinois | United States | 60611 |
31 | The University of Chicago Medicine | Chicago | Illinois | United States | 60637 |
32 | University of Kansas Medical Center Research Institute | Fairway | Kansas | United States | 66205 |
33 | Kansas Medical Clinic - Gastroenterology | Topeka | Kansas | United States | 66606 |
34 | Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge | Baton Rouge | Louisiana | United States | 70809 |
35 | Tandem Clinical Research | Marrero | Louisiana | United States | 70072 |
36 | Ochsner Medical Center | New Orleans | Louisiana | United States | 70121 |
37 | Clinical Trials of America | West Monroe | Louisiana | United States | 71291 |
38 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889 |
39 | Gastrointestinal Associates and Endoscopy Center - Madison | Flowood | Mississippi | United States | 39232 |
40 | Southern Therapy and Advanced Research | Jackson | Mississippi | United States | 39216 |
41 | Kansas City Research Institute | Kansas City | Missouri | United States | 64131 |
42 | Saint Louis University | Saint Louis | Missouri | United States | 63104 |
43 | Clinical Research US - Henderson | Henderson | Nevada | United States | 89052 |
44 | Mt. Sinai Medical Center | New York | New York | United States | 10029 |
45 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
46 | Cumberland Research Associates | Fayetteville | North Carolina | United States | 28304 |
47 | Lucas Research | Morehead City | North Carolina | United States | 28557 |
48 | Consultants for Clinical Research | Cincinnati | Ohio | United States | 45249 |
49 | Aventiv Research - Columbus | Columbus | Ohio | United States | 43213 |
50 | Awasty Research Network | Marion | Ohio | United States | 43302 |
51 | Premier Medical Group - Clarksville | Clarksville | Tennessee | United States | 37040 |
52 | Gastro One - Germantown - Centre Oak Way | Germantown | Tennessee | United States | 38138 |
53 | Associates in Gastroenterology | Hermitage | Tennessee | United States | 37076 |
54 | Gastrointestinal Associates - Knoxville | Knoxville | Tennessee | United States | 37909 |
55 | Dallas Research Center | Dallas | Texas | United States | 75234 |
56 | Liver Center of Texas | Dallas | Texas | United States | 75234 |
57 | Texas Digestive Disease Consultants - Dallas | Dallas | Texas | United States | 75234 |
58 | The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | United States | 75234 |
59 | South Texas Research Institute | Edinburg | Texas | United States | 78539 |
60 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
61 | Texas Digestive Disease Consultants - Fort Worth | Fort Worth | Texas | United States | 76104 |
62 | Liver Associates of Texas | Houston | Texas | United States | 77030 |
63 | Doctor's Hospital at Renaissance | McAllen | Texas | United States | 78504 |
64 | Plano Research Center | Plano | Texas | United States | 75093 |
65 | Pinnacle Clinical Research - Austin | Rollingwood | Texas | United States | 78746 |
66 | Pinnacle Clinical Research | San Antonio | Texas | United States | 78229 |
67 | San Antonio Research Center | San Antonio | Texas | United States | 78229 |
68 | The Texas Liver Institute | San Antonio | Texas | United States | 78229 |
69 | Texas Digestive Disease Consultants - San Marcos | San Marcos | Texas | United States | 78666 |
70 | Texas Digestive Disease Consultants - Bay Area Gastroenterology | Webster | Texas | United States | 77598 |
71 | Wasatch Peak Family Practice | Layton | Utah | United States | 84041 |
72 | Salt Lake City Research Center | Murray | Utah | United States | 84123 |
73 | University of Virginia Health System | Charlottesville | Virginia | United States | 22903 |
74 | Bon Secours St. Mary's Hospital of Richmond | Richmond | Virginia | United States | 23226 |
75 | Hunter Holmes McGuire Veterans Administration Medical Center | Richmond | Virginia | United States | 23249 |
76 | Virginia Commonwealth University | Richmond | Virginia | United States | 23249 |
77 | Liver Institute Northwest | Seattle | Washington | United States | 98105 |
78 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
79 | Saint Vincent's Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
80 | Nepean Hospital | Kingswood | New South Wales | Australia | 2747 |
81 | John Hunter Hospital | New Lambton | New South Wales | Australia | 2305 |
82 | Westmead Hospital | Westmead | New South Wales | Australia | 2145 |
83 | Royal Brisbane and Women's Hospital | Herston | Queensland | Australia | 4029 |
84 | Mater Misericordiae | South Brisbane | Queensland | Australia | 4101 |
85 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
86 | Monash Medical Centre | Clayton | Victoria | Australia | 3168 |
87 | Austin Health | Heidelberg | Victoria | Australia | 3084 |
88 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
89 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
90 | Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia | 6009 |
91 | Royal Perth Hospital | Perth | Western Australia | Australia | 6000 |
92 | Klinikum Klagenfurt Am Wörthersee | Klagenfurt | Carinthia | Austria | |
93 | Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | Upper Austria | Austria | |
94 | Krankenanstalt Rudolfstiftung | Wien | Vienna | Austria | |
95 | Landesklinik St. Veit | Salzburg | Austria | ||
96 | Medizinische Universität Wien | Vienna | Austria | ||
97 | Klinikum Wels-Grieskirchen | Wels | Austria | ||
98 | Universitair Ziekenhuis Antwerpen | Edegem | Antwerpen | Belgium | |
99 | Hôpital Erasme | Bruxelles | Brussels | Belgium | |
100 | Universitair Ziekenhuis Leuven | Leuven | Flemish Brabant | Belgium | |
101 | Ziekenhuis Oost-Limburg' | Genk | Limburg | Belgium | |
102 | Algemeen Ziekenhuis Maria Middelares | Gent | Oost-Vlaanderen | Belgium | |
103 | Universitair Ziekenhuis Gent | Gent | Oost-Vlaanderen | Belgium | |
104 | AZ Delta Campus Wilgenstraat | Roeselare | West-Vlaanderen | Belgium | |
105 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | ||
106 | Centre Hospitalier Universitaire Brugmann | Laeken | Belgium | ||
107 | Universitair Ziekenhuis Leuven | Leuven | Belgium | ||
108 | University of Calgary Liver Unit | Calgary | Alberta | Canada | |
109 | University of Alberta | Edmonton | Alberta | Canada | |
110 | South Shore Medical Arts | Bridgewater | Nova Scotia | Canada | |
111 | LMC/ Manna Research - Brampton | Brampton | Ontario | Canada | |
112 | William Osler Health System | Brampton | Ontario | Canada | |
113 | McMaster University | Hamilton | Ontario | Canada | |
114 | Toronto General Hospital - Clinical Trials Pharmacy | Toronto | Ontario | Canada | |
115 | Toronto Liver Center | Toronto | Ontario | Canada | |
116 | GI Research Institute | Vancouver | Canada | ||
117 | Nouvel Hôpital Civil | Strasbourg Cedex | Alsace | France | |
118 | Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre | Strasbourg | Alsace | France | |
119 | Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | Auvergne | France | |
120 | Centre Hospitalier Universitaire de Rennes | Rennes Cedex 9 | Bretagne | France | |
121 | Hôpital Jean-Minjoz | Besançon | Franche-Comte | France | |
122 | Hôpital Avicenne | Bobigny Cedex | Ile-de-France | France | |
123 | Centre Hospitalier Universitaire Henri Mondor | Créteil Cedex | Ile-de-France | France | |
124 | Assistance Publique-Hôpitaux de Paris Hôpital Cochin | Paris Cedex 14 | Ile-de-France | France | |
125 | Centre Hospitalier Universitaire de Montpellier | Montpellier Cedex 5 | Languedoc-Roussillon | France | |
126 | Hôpital Dupuytren | Limoges | Limousin | France | |
127 | Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil | Toulouse Cedex | Midi-Pyrenees | France | |
128 | Centre Hospitalier Régional Universitaire de Lille | Lille | Nord Pas-de-Calais | France | |
129 | Center Hospitalier Universitaire d'Angers | Angers | Pays De La Loire | France | |
130 | Centre Hospitalier Universitaire de Nice Hôpital l'Archet | Nice Cedex 3 | Provence Alpes Cote D'Azur | France | |
131 | Hôpital de la Croix Rousse | Lyon Cedex 04 | Rhone-Alpes | France | |
132 | Centre Hospitalier Universitaire Amiens-Picardie | Amiens | France | ||
133 | Hôpital Beaujon | Clichy | France | ||
134 | Hôpital Universitaire Pitié Salpêtrière | Paris Cedex 13 | France | ||
135 | Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois | Vandœuvre-lès-Nancy | France | ||
136 | Berlin Clinical Research Center | Berlin | Germany | ||
137 | Charité Universitätsmedizin Berlin - Campus Mitte | Berlin | Germany | ||
138 | Charité Universitätsmedizin Berlin | Berlin | Germany | ||
139 | EPIMED | Berlin | Germany | ||
140 | Zentrum für Infektiologie Berlin Prenzlauer Berg | Berlin | Germany | ||
141 | Frankfurt Clinical Research Center | Frankfurt am main | Germany | ||
142 | Universitätsklinikum Frankfurt | Frankfurt am main | Germany | ||
143 | Universitätsklinikum des Saarlandes | Homburg | Germany | ||
144 | EUGASTRO | Leipzig | Germany | ||
145 | Leipzig Research Center | Leipzig | Germany | ||
146 | SIBAmed Studienzentrum | Leipzig | Germany | ||
147 | Universitätsklinikum Würzburg | Würzburg | Germany | ||
148 | Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház | Békéscsaba | Bekes | Hungary | |
149 | Magyarország Egészségügyi Szolgáltató - Gyula | Gyula | Bekes | Hungary | |
150 | Debreceni Egyetem Kenézy Gyula Egyetemi Kórház | Debrecen | Hajdu-Bihar | Hungary | |
151 | Magyarország Research Center | Debrecen | Hajdu-Bihar | Hungary | |
152 | Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház | Nyíregyháza | Szabolcs-Szatmar-Bereg | Hungary | |
153 | Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet | Budapest | Hungary | ||
154 | Magyarország Research Center | Budapest | Hungary | ||
155 | The Chaim Sheba Medical Center | Ramat Gan | Tel Aviv | Israel | |
156 | Emek Medical Center | Afula | Israel | ||
157 | Soroka University Medical Center | Be'er Sheva | Israel | ||
158 | Rambam Health Care Campus - Rambam Medical Center | Haifa | Israel | ||
159 | The Lady Davis Carmel Medical Center | Haifa | Israel | ||
160 | Hadassah University Hospital Ein Kerem | Jerusalem | Israel | ||
161 | Shaare Zedek Medical Center | Jerusalem | Israel | ||
162 | Western Galilee Hospital-Nahariya | Nahariya | Israel | ||
163 | Holy Family Hospital | Nazareth | Israel | ||
164 | Rabin Medical Center | Petah Tikva | Israel | ||
165 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | ||
166 | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | ||
167 | Azienda Ospedaliero - Universitaria Careggi | Firenze | Italy | ||
168 | Azienda Ospedaliera Universitaria Policlinico Gaetano Martino | Messina | Italy | ||
169 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | ||
170 | Polo Universitario - L'Azienda Ospedaliera Luigi Sacco | Milano | Italy | ||
171 | Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara | Novara | Italy | ||
172 | Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo | Italy | ||
173 | Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) | Palermo | Italy | ||
174 | Fondazione Policlinico Universitario Agostino Gemelli | Roma | Italy | ||
175 | Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma | Roma | Italy | ||
176 | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | ||
177 | Polska Oddział w Częstochowie | Częstochowa | Poland | ||
178 | Polska Oddział w Gdansk | Gdańsk | Poland | ||
179 | Polska Oddział w Gdyni | Gdynia | Poland | ||
180 | Polska Oddział w Katowicach | Katowice | Poland | ||
181 | Polska Oddział w Poznaniu | Poznań | Poland | ||
182 | Polska Oddział w Warszawie | Warszawa | Poland | ||
183 | Polska Oddział w Wrocław | Wrocław | Poland | ||
184 | Polska Oddział w Łodz | Łódź | Poland | ||
185 | Fundación De Investigación De Diego | San Juan | Puerto Rico | ||
186 | Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid | Spain | |
187 | Complejo Hospitalario Torrecárdenas | Almeria | Spain | ||
188 | Hospital de la Santa Creu i de Sant Pau | Barcelona | Spain | ||
189 | Hospital del Mar - Parc de Salut Mar | Barcelona | Spain | ||
190 | Hospital Universitari Vall d'Hebrón | Barcelona | Spain | ||
191 | Hospital General Universitario Gregorio Marañón | Madrid | Spain | ||
192 | Hospital Universitario Ramón Y Cajal | Madrid | Spain | ||
193 | Complejo Hospitalario de Pontevedra | Pontevedra | Spain | ||
194 | Hospital Universitario Marqués de Valdecilla | Santander | Spain | ||
195 | Hospital Universitario Virgen del Rocio | Sevilla | Spain | ||
196 | Consorci Hospital General Universitari de València | Valencia | Spain | ||
197 | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Spain | ||
198 | Universitatsspital Bern | Bern | Switzerland | ||
199 | Fondazione Epatocentro Ticino | Lugano | Switzerland | ||
200 | Universitatsspital Zurich | Zürich | Switzerland | ||
201 | Midlands Clinical Research Centre | Birmingham | England | United Kingdom | |
202 | University Hospitals Birmingham NHS Foundation Trust | Birmingham | England | United Kingdom | |
203 | Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | United Kingdom | |
204 | Lancashire Clinical Research Centre | Chorley | England | United Kingdom | |
205 | North Teesside Clinical Research Centre | Hardwick | England | United Kingdom | |
206 | Merseyside Clinical Research Centre | Liverpool | England | United Kingdom | |
207 | Barts Health NHS Trust | London | England | United Kingdom | |
208 | Chelsea and Westminster Hospital NHS Foundation Trust | London | England | United Kingdom | |
209 | Imperial College Healthcare NHS Trust | London | England | United Kingdom | |
210 | Royal Free London NHS Foundation Trust | London | England | United Kingdom | |
211 | Manchester Clinical Research Centre | Manchester | England | United Kingdom | |
212 | The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | England | United Kingdom | |
213 | Norfolk and Norwich University Hospital | Norwich | England | United Kingdom | |
214 | Nottingham University Hospitals NHS Trust | Nottingham | England | United Kingdom | |
215 | Thames Valley Dedicated Research Centre | Reading | England | United Kingdom | |
216 | Belfast Health and Social Care Trust | Belfast | Northern Ireland | United Kingdom | |
217 | The Hexham Clinic | Hexham | Northumberland, England | United Kingdom | |
218 | The Wales Clinic | Cardiff | Wales | United Kingdom | |
219 | Abertawe Bro Morgannwg University Health Board | Swansea | Wales | United Kingdom | |
220 | Aintree University Hospitals NHS Foundation Trust | Liverpool | United Kingdom | ||
221 | Saint George's University Hospitals NHS Foundation Trust | London | United Kingdom | ||
222 | Plymouth Hospitals NHS Trust | Plymouth | United Kingdom | ||
223 | Portsmouth Hospitals NHS Trust | Portsmouth | United Kingdom |
Sponsors and Collaborators
- Madrigal Pharmaceuticals, Inc.
Investigators
- Study Director: Rebecca Taub, MD, Madrigal Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MGL-3196-11