A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis
This is a Phase 2 study in which JKB-122 is given once daily for 52 weeks to subjects with Nonalcoholic steatohepatitis (NASH) with Fibrosis who have biopsy reading more than NAS 4 with a fibrosis reading more than 1 and no cirrhosis. Subjects will be at least 18 years of age, either male or female.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
To evaluate the effect of JKB-122 compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving NASH resolution with at least a 2 point reduction in NAS and no worsening of fibrosis
Time frame: 52 weeks
To evaluate the effect of JKB-122 compared to placebo to achieve a ≥ 1 stage fibrosis improvement on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving at least a 1 stage improvement in fibrosis (NASH Clinical Research Network system) by liver biopsy with no worsening of NAS.
Time frame: 52 weeks
Evaluate the changes of hepatic fat content
The changes of fatty liver content (%) will be measured by MRI-PDFF.
Time frame: 52 weeks
Evaluate the changes of fibrosis score
The changes of fibrosis score (kPa) will be measured by FibroScan.
Time frame: 52 weeks
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