Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, NASH, ASC41, Phase II, THR-β
Brief summary
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
Interventions
DRUG2mg of ASC41
ASC41 tablet administered orally once daily.
DRUG4mg of ASC41 (2 tablets of 2 mg ASC41)
ASC41 tablets administered orally once daily.
DRUGPlacebo
Placebo tablets administered orally once daily.
Sponsors
Gannex Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 80 years old at screening. * Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit. * HbA1c ≤ 9.5%. * Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m\^2
Exclusion criteria
* Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma. * History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings. * Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of \> 9.5% within 60 days prior to enrollment. * Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change. | Baseline and Week 52 | A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in hepatic fat fraction assessed by MRI-PDFF | 24 and 52 weeks | — |
| To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL) | 12, 24 and 52 weeks | — |
| The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo | 24 and 52 weeks | — |
| Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞) | 1 and 15 Days | — |
| Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax) | 1 and 15 Days | — |
| Plasma pharmacokinetics - Peak Plasma Concentration (Cmax) | 1 and 15 Days | Measured after administration |
Countries
China
Outcome results
None listed