NASH Clinical Trial
Official title:
Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | June 2025 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Able to understand and comply with study procedures and give written informed consent - Age =18 years - NAS =4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization - Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization - Meet all inclusion criteria outlined in clinical study protocol Exclusion Criteria: - Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study - Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol - Evidence of other forms of chronic liver disease as defined in clinical study protocol - Does not meet any other exclusion criteria outlined in clinical study protocol |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Acibadem City Clinic Cancer Center | Sofia | Nikola |
| Bulgaria | Acibadem City Clinic Toku da University Hospital | Sofia | Nikola |
| Bulgaria | DCC Alexandrovska | Sofia | Nikola |
| Canada | University of Calgary | Calgary | Alberta |
| Canada | Ecogene-21 | Chicoutimi | Quebec |
| Canada | Diex Recherche Quebec Inc. | Quebec City | Quebec |
| Japan | Asahikawa Medical University Hospital | Asahikawa | |
| Japan | Fukui-ken Saiseikai Hospital | Fukui | |
| Japan | SHIN-YURIGAOKA General Hospital | Kawasaki | |
| Japan | Kurume University Hospital | Kurume | |
| Japan | Shinshu University Hospital | Matsumoto | |
| Japan | Japanese Red Cross Musashino Hospital | Musashino | |
| Japan | Nagano Japan | Nagano | |
| Japan | Saiseikai Niigata Hospital | Niigata | |
| Japan | Ogaki Municipal Hospital | Ogaki | |
| Japan | Kawasaki Medical School General Medical Center | Okayama | |
| Japan | Saga University Hospital | Saga | |
| Japan | JCHO Hokkaido Hospital | Sapporo | |
| Japan | Nippon Medical School Hospital | Tokyo | |
| Japan | Ehime University Hospital | Toon | |
| Japan | Yokohama City University Hospital | Yokohama | |
| Spain | Hospital Abente Y Lago Complejo | Coruna | |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | Cabtabria |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | GI Alliance Research | Cedar Park | Texas |
| United States | JAVARA, Inc. / Tryon Medical Partners, PLLC | Charlotte | North Carolina |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | GI Associates Research, LLC | Columbia | Missouri |
| United States | Centricity Research | Columbus | Georgia |
| United States | Arcare Center for Clinical Research | Conway | Arkansas |
| United States | GI Alliance Research | Dallas | Texas |
| United States | DSI Research Northridge, LLC | Dayton | Ohio |
| United States | GI Alliance Research | Flowood | Mississippi |
| United States | GI Alliance Research | Garland | Texas |
| United States | Birmingham Digestive Health Research, Inc. | Homewood | Alabama |
| United States | Velocity Clinical Research | Huntington Park | California |
| United States | Nature Coast Clinical Research, LLC | Inverness | Florida |
| United States | Southern Therapy and Advanced Research, LLC | Jackson | Mississippi |
| United States | ENCORE Borland Groover Clinical Research | Jacksonville | Florida |
| United States | Jefferson City Medical Group | Jefferson City | Missouri |
| United States | Clinical Trials Research | Lincoln | California |
| United States | Arcare Center for Clinical Research | Little Rock | Arkansas |
| United States | United Clinical Research Institute | Los Alamitos | California |
| United States | Velocity Clinical Research | Los Angeles | California |
| United States | Gastrointestinal Specialists of Georgia | Marietta | Georgia |
| United States | Tandem Clinical Research | Marrero | Louisiana |
| United States | Lucas Research, Inc. | Morehead City | North Carolina |
| United States | Sensible Healthcare Clinical Research | Ocoee | Florida |
| United States | FOMAT Medical Research | Oxnard | California |
| United States | Pensacola GI Research Center | Pensacola | Florida |
| United States | GI Select Health Research | Richmond | Virginia |
| United States | Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas |
| United States | Endeavor Clinical Trials | San Antonio | Texas |
| United States | Northeast Cliical Research of San Antonio, LLC | San Antonio | Texas |
| United States | GI Alliance Research | San Marcos | Texas |
| United States | Centricity | Suffolk | Virginia |
| United States | Tampa General Medical Group | Tampa | Florida |
| United States | Digestive Health Research of Central Texas, LLC | Waco | Texas |
| United States | Impact Clinical Research | Waco | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Kowa Research Institute, Inc. |
United States, Bulgaria, Canada, Japan, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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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