Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327127
• Other study ID #: K-001-201
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Kowa Research Institute, Inc.
• Contact: Director, Clinical Operations
• Phone: 919-433-1600
• Email: Clinical[@]KowaUS.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Liver Cirrhosis
• NASH

Intervention

Drug:
• K-877-ER
K-877-ER tablet
• CSG452
CSG452 tablet
• Placebo
Placebo tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Japan,  Spain, 

Outcome

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