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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05327127
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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).

Condition or disease Intervention/treatment Phase
NASH Drug: K-877-ER Drug: CSG452 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025


Arm Intervention/treatment
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: K-877-ER
K-877-ER tablet

Drug: Placebo
Placebo tablet

Experimental: CSG452
CSG452 and K-877-ER Placebo QD
Drug: CSG452
CSG452 tablet

Drug: Placebo
Placebo tablet

Placebo Comparator: Placebo Drug: Placebo
Placebo tablet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327127


Contacts
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Contact: Director, Clinical Operations 919-433-1600 Clinical@KowaUS.com

Locations
Show Show 32 study locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Chair: Shona Pendse, MD, MMSc Kowa Research Institute, Inc.
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT05327127    
Other Study ID Numbers: K-001-201
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: December 5, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs