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

• Sponsor: Kowa Research Institute, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05327127
• Collaborator: (none)
• Enrollment: 400
• Locations: 6
• Arms: 4
• Anticipated Duration (Months): 24
• Patients Per Site: 66.7
• Patients Per Site Per Month: 2.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
NASH	Drug: K-877-ER; Drug: CSG452; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improvement in disease activity and no worsening of liver fibrosis (Yes/No) [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) [52 Weeks]

   Time frame is 52 weeks unless an unresolved AE is still being followed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Clinical Research Institute	Los Alamitos	California	United States	90720
2	Velocity Research	Los Angeles	California	United States	90057
3	Nature Coast Clinical Research	Inverness	Florida	United States	34452
4	ENCORE Borland Groover Clinical Research	Jacksonville	Florida	United States	32256
5	University of Michigan	Ann Arbor	Michigan	United States	48109
6	Lucas Research	Morehead City	North Carolina	United States	28557

Sponsors and Collaborators

• Kowa Research Institute, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kowa Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT05327127
• Other Study ID Numbers: K-001-201
• First Posted: Apr 14, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Study Results

No Results Posted as of Aug 18, 2022