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

Kowa

Status and phase: Enrolling; Phase 2

Conditions: NASH

Treatments: Drug: K-877-ER; Drug: Placebo; Drug: CSG452

Study type: Interventional

Funder types: Industry

Identifiers

NCT05327127

K-001-201

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

K-001

Experimental group

Description:

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

Treatment:

Drug: CSG452

Drug: K-877-ER

K-877-ER

Experimental group

Description:

K-877-ER and CSG452 Placebo QD

Treatment:

Drug: Placebo

Drug: K-877-ER

CSG452

Experimental group

Description:

CSG452 and K-877-ER Placebo QD

Treatment:

Drug: CSG452

Drug: Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo