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

February 29, 2024 updated by: Kowa Research Institute, Inc.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
    • Nikola
      • Sofia, Nikola, Bulgaria, 1407
        • Recruiting
        • Acibadem City Clinic Toku da University Hospital
      • Sofia, Nikola, Bulgaria, 1431
        • Recruiting
        • DCC Alexandrovska
      • Sofia, Nikola, Bulgaria, 1784
        • Recruiting
        • Acibadem City Clinic Cancer Center
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Recruiting
        • Ecogene-21
      • Quebec City, Quebec, Canada, G1V 4T3
        • Recruiting
        • Diex Recherche Quebec Inc.
  • Japan
      • Asahikawa, Japan
        • Recruiting
        • Asahikawa Medical University Hospital
      • Fukui, Japan
        • Recruiting
        • Fukui-ken Saiseikai Hospital
      • Kawasaki, Japan
        • Recruiting
        • Shin-yurigaoka General Hospital
      • Kurume, Japan
        • Recruiting
        • Kurume University Hospital
      • Matsumoto, Japan
        • Recruiting
        • Shinshu University Hospital
      • Musashino, Japan
        • Recruiting
        • Japanese Red Cross Musashino Hospital
      • Nagano, Japan
        • Recruiting
        • Nagano Municipal Hospital
      • Niigata, Japan
        • Recruiting
        • Saiseikai Niigata Hospital
      • Okayama, Japan
        • Recruiting
        • Kawasaki Medical School General Medical Center
      • Saga, Japan
        • Recruiting
        • Saga University Hospital
      • Sapporo, Japan
        • Recruiting
        • JCHO Hokkaido Hospital
      • Tokyo, Japan
        • Recruiting
        • Nippon Medical School Hospital
      • Tōon, Japan
        • Recruiting
        • Ehime University Hospital
      • Yokohama, Japan
        • Recruiting
        • Yokohama City University Hospital
      • Ōgaki, Japan
        • Recruiting
        • Ogaki Municipal Hospital
  • Spain
      • Coruna, Spain, 15006
        • Recruiting
        • Hospital Abente Y Lago Complejo
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
    • Cabtabria
      • Santander, Cabtabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Birmingham Digestive Health Research, Inc.
    • Arkansas
      • Conway, Arkansas, United States, 72032
        • Recruiting
        • ARcare Center for Clinical Research
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • ARcare Center for Clinical Research
    • California
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Velocity Clinical Research
      • Lincoln, California, United States, 95648
        • Recruiting
        • Clinical Trials Research
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • United Clinical Research Institute
      • Los Angeles, California, United States, 90057
        • Recruiting
        • Velocity Clinical Research
      • Oxnard, California, United States, 93030
        • Recruiting
        • FOMAT Medical Research
    • Florida
      • Inverness, Florida, United States, 34452
        • Recruiting
        • Nature Coast Clinical Research, LLC
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • ENCORE Borland Groover Clinical Research
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Sensible Healthcare Clinical Research
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Pensacola GI Research Center
      • Tampa, Florida, United States, 36606
        • Recruiting
        • Tampa General Medical Group
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Centricity Research
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Gastrointestinal Specialists of Georgia
    • Iowa
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Iowa Digestive Disease Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • GI Alliance Research
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Southern Therapy and Advanced Research, LLC
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • GI Associates Research, LLC
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Jefferson City Medical Group
    • North Carolina
      • Charlotte, North Carolina, United States, 28287
        • Recruiting
        • JAVARA, Inc. / Tryon Medical Partners, PLLC
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research, Inc.
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Recruiting
        • DSI Research Northridge, LLC
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • GI Alliance Research
      • Dallas, Texas, United States, 75246
        • Recruiting
        • GI Alliance Research
      • Garland, Texas, United States, 75044
        • Recruiting
        • GI Alliance Research
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Endeavor Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Diabetes and Glandular Disease Clinic, P.A.
      • San Antonio, Texas, United States, 78233
        • Recruiting
        • Northeast Cliical Research of San Antonio, LLC
      • San Marcos, Texas, United States, 78666
        • Recruiting
        • GI Alliance Research
      • Waco, Texas, United States, 76712
        • Recruiting
        • Digestive Health Research of Central Texas, LLC
      • Waco, Texas, United States, 76710
        • Recruiting
        • Impact Clinical Research
    • Virginia
      • Richmond, Virginia, United States, 23236
        • Recruiting
        • GI Select Health Research
      • Suffolk, Virginia, United States, 23435
        • Recruiting
        • Centricity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet
Experimental: K-001
K-877-ER and CSG452 Once daily (QD)
Drug: K-877-ER
K-877-ER tablet
Drug: CSG452
CSG452 tablet
Experimental: K-877-ER
K-877-ER and CSG452 Placebo QD
Drug: Placebo
Placebo tablet
Drug: K-877-ER
K-877-ER tablet
Experimental: CSG452
CSG452 and K-877-ER Placebo QD
Drug: Placebo
Placebo tablet
Drug: CSG452
CSG452 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
Time Frame: Baseline to Week 48
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Related Adverse Events (AE)
Time Frame: 52 Weeks
Time frame is 52 weeks unless an unresolved AE is still being followed
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kowa Research Institute, Inc.

Investigators

  • Study Chair: Shona Pendse, MD, MMSc, Kowa Research Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-001-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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