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

Primary Purpose

NASH

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
K-877-ER
CSG452
Placebo
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 12 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 12 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 significant 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

Sites / Locations

  • Birmingham Digestive Health Research, Inc.Recruiting
  • Arcare Center for Clinical ResearchRecruiting
  • Arcare Center for Clinical ResearchRecruiting
  • Velocity Clinical ResearchRecruiting
  • Clinical Trials ResearchRecruiting
  • United Clinical Research InstituteRecruiting
  • Velocity Clinical ResearchRecruiting
  • FOMAT Medical ResearchRecruiting
  • Nature Coast Clinical Research, LLCRecruiting
  • ENCORE Borland Groover Clinical ResearchRecruiting
  • Sensible Healthcare Clinical ResearchRecruiting
  • Pensacola GI Research CenterRecruiting
  • Tampa General Medical GroupRecruiting
  • Centricity ResearchRecruiting
  • Gastrointestinal Specialists of GeorgiaRecruiting
  • Iowa Digestive Disease CenterRecruiting
  • Tandem Clinical ResearchRecruiting
  • University of MichiganRecruiting
  • GI Alliance ResearchRecruiting
  • Southern Therapy and Advanced Research, LLCRecruiting
  • GI Associates Research, LLCRecruiting
  • Jefferson City Medical GroupRecruiting
  • JAVARA, Inc. / Tryon Medical Partners, PLLCRecruiting
  • Lucas Research, Inc.Recruiting
  • DSI Research Northridge, LLCRecruiting
  • GI Alliance ResearchRecruiting
  • GI Alliance ResearchRecruiting
  • GI Alliance ResearchRecruiting
  • Diabetes and Glandular Disease Clinic, P.A.Recruiting
  • Northeast Cliical Research of San Antonio, LLCRecruiting
  • Endeavor Clinical TrialsRecruiting
  • GI Alliance ResearchRecruiting
  • Impact Clinical ResearchRecruiting
  • Digestive Health Research of Central Texas, LLCRecruiting
  • GI Select Health ResearchRecruiting
  • CentricityRecruiting
  • Acibadem City Clinic Toku da University HospitalRecruiting
  • DCC AlexandrovskaRecruiting
  • Acibadem City Clinic Cancer CenterRecruiting
  • University of CalgaryRecruiting
  • Ecogene-21Recruiting
  • Diex Recherche Quebec Inc.Recruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Abente Y Lago ComplejoRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

K-001

K-877-ER

CSG452

Placebo

Arm Description

K-877-ER and CSG452 Once daily (QD)

K-877-ER and CSG452 Placebo QD

CSG452 and K-877-ER Placebo QD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Treatment-Related Adverse Events (AE)
Time frame is 52 weeks unless an unresolved AE is still being followed

Full Information

First Posted
March 2, 2022
Last Updated
June 1, 2023
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05327127
Brief Title
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
K-001
Arm Type
Experimental
Arm Description
K-877-ER and CSG452 Once daily (QD)
Arm Title
K-877-ER
Arm Type
Experimental
Arm Description
K-877-ER and CSG452 Placebo QD
Arm Title
CSG452
Arm Type
Experimental
Arm Description
CSG452 and K-877-ER Placebo QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
K-877-ER
Intervention Description
K-877-ER tablet
Intervention Type
Drug
Intervention Name(s)
CSG452
Intervention Description
CSG452 tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Improvement in disease activity and no worsening of liver fibrosis (Yes/No)
Description
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.
Time Frame
Baseline to Week 48
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events (AE)
Description
Time frame is 52 weeks unless an unresolved AE is still being followed
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director, Clinical Operations
Phone
919-433-1600
Email
Clinical@KowaUS.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shona Pendse, MD, MMSc
Organizational Affiliation
Kowa Research Institute, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Digestive Health Research, Inc.
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Arcare Center for Clinical Research
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72032
Country
United States
Individual Site Status
Recruiting
Facility Name
Arcare Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Individual Site Status
Recruiting
Facility Name
United Clinical Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
FOMAT Medical Research
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Individual Site Status
Recruiting
Facility Name
Nature Coast Clinical Research, LLC
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Name
ENCORE Borland Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Sensible Healthcare Clinical Research
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Pensacola GI Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
36606
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Therapy and Advanced Research, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Associates Research, LLC
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
Jefferson City Medical Group
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Individual Site Status
Recruiting
Facility Name
JAVARA, Inc. / Tryon Medical Partners, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28287
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
DSI Research Northridge, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Individual Site Status
Recruiting
Facility Name
Diabetes and Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Northeast Cliical Research of San Antonio, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Individual Site Status
Recruiting
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Alliance Research
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Name
Impact Clinical Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Research of Central Texas, LLC
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Select Health Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic Toku da University Hospital
City
Sofia
State/Province
Nikola
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Alexandrovska
City
Sofia
State/Province
Nikola
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic Cancer Center
City
Sofia
State/Province
Nikola
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Diex Recherche Quebec Inc.
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cabtabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Abente Y Lago Complejo
City
Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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