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A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-001 | Experimental | K-877-ER and CSG452 Once daily (QD) |
|
| K-877-ER | Experimental | K-877-ER and CSG452 Placebo QD |
|
| CSG452 | Experimental | CSG452 and K-877-ER Placebo QD |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877-ER | Drug | K-877-ER tablet |
| |
| CSG452 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in disease activity and no worsening of liver fibrosis (Yes/No) | The improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥2 points. The worsening of fibrosis is defined as any numerical increase in the stage. | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (AE) | Time frame is 52 weeks unless an unresolved AE is still being followed | 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shona Pendse, MD, MMSc | Kowa Research Institute, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | United States | ||
| Arizona Liver Health |
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| Drug |
CSG452 tablet |
|
| Placebo | Drug | Placebo tablet |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Arcare Center for Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| United Clinical Research Institute | Los Alamitos | California | 90720 | United States |
| Velocity Clinical Research | Los Angeles | California | 90057 | United States |
| Alliance Clinical Research | Poway | California | 92064 | United States |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | United States |
| ENCORE Borland Groover Clinical Research | Jacksonville | Florida | 32256 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| Ocala GI Research | Ocala | Florida | 34471 | United States |
| Sensible Healthcare Clinical Research, LLC | Ocoee | Florida | 34761 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | United States |
| Mid-Atlantic GI Research, LLC | Greenbelt | Maryland | 20770 | United States |
| Boston Medical Center Boston University Chobanian & Avedisian School of Medicine | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| GI Alliance Research | Flowood | Mississippi | 39232 | United States |
| GI Associates Research, LLC | Columbia | Missouri | 65201 | United States |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | United States |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | United States |
| DSI Research Northridge, LLC | Dayton | Ohio | 45414 | United States |
| Penn State Health/Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| GI Alliance Research | Cedar Park | Texas | 78613 | United States |
| GI Alliance Research | Dallas | Texas | 75246 | United States |
| GI Alliance Research | Garland | Texas | 75044 | United States |
| GLRI McAllen Research | Pharr | Texas | 78577 | United States |
| Northeast Clinical Rsearch of San Antonio | San Antonio | Texas | 78233 | United States |
| Endeavor Clinical Trials | San Antonio | Texas | 78240 | United States |
| Impact Research Institute | Waco | Texas | 76710 | United States |
| Digestive Health Research of Central Texas, LLC | Waco | Texas | 76712 | United States |
| North Richmond Health Research | Richmond | Virginia | 23229 | United States |
| GI Select Health Research | Richmond | Virginia | 23236 | United States |
| Centricity | Suffolk | Virginia | 23435 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| Hospital Italiano de Buenos Aires | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1199 | Argentina |
| CINME - Centro De Investigaciones Metabolicas | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1056ABJ | Argentina |
| Hospital Italiano de La Plata | La Plata | Buenos Aires | 1900 | Argentina |
| Instituto de Investigaciones Clinicas de Mar del Plata | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Hospital Universitario Austra | Pilar | Buenos Aires | B1629ODT | Argentina |
| Hospital Provincial del Centenario | Santa Fe | Rosario | S2002KDS | Argentina |
| Clínica de Endocrinologia e Metabologia Ltda | Brasília | Brasilia DF | 71625-009 | Brazil |
| Hospital Alianca Rede D 'Or | Salvador | Estado de Bahia | 41920-900 | Brazil |
| Hospital Universitário João de Barros Barreto | Belém | Pará | 66073-000 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Porto Alegre RS | 90035-903 | Brazil |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| Fujita Health University Hospital | Toyoake | Aichi-ken | 470-1192 | Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Fukui-ken Saiseikai Hospital | Fukui-shi | Fukui | 918-8503 | Japan |
| Ogaki Municipal Hospital | Ōgaki | Gifu | 503-8502 | Japan |
| NHO Takasaki General Medical Center | Takasaki Shi | Gumna | 370-0829 | Japan |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima | Hiroshima | 730-8619 | Japan |
| NHO Kure Medical Center and Chugoku Cancer Center | Kure Shi | Hiroshima | 737-0023 | Japan |
| Asahikawa Medical University Hospital | Asahikawa | Hokkaido | 078-8510 | Japan |
| JCHO Hokkaido Hospital | Sapporo | Hokkaido | 062-8618 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| SHIN-YURIGAOKA General Hospital | Kawasaki | Kanagawa | 215-0026 | Japan |
| St. Marianna University School of Medicine | Kawasaki | Kanagawa | 216-8511 | Japan |
| Yokohama City University Hospital | Yokohama | Kanagawa | 236-0004 | Japan |
| Tohoku Rosai Hospital | Sendai | Miyagi | 981-8563 | Japan |
| Shinshu University Hospital | Matsumoto Shi | Nagano | 390-8621 | Japan |
| Nagano municipal Hospital | Nagano | Nagano | 381-0006 | Japan |
| Saiseikai Niigata Hospital | Niigata | Niigata | 950-1104 | Japan |
| Kawasaki Medical School General Medical Center | Okayama | Okayama-ken | 700-8505 | Japan |
| Saga University Hospital | Saga | Saga-ken | 849-8501 | Japan |
| Japanese Red Cross Musashino Hospital | Musashino | Tokyo | 180-8610 | Japan |
| Nippon Medical School Hospital | Bunkyō City | Toyko | 113-8603 | Japan |
| Oita Cardiovascular Hospital | Ōita | 870-0837 | Japan |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complejo Hospitalario Universitario A Coruna | A Coruña | 15001 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Puerta De Hierro | Madrid | 28222 | Spain |
| ID | Term |
|---|---|
| C575086 | 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol |
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