Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Low Dose | Experimental | 1 tablet of ASC41 (2 mg) for 52 weeks |
|
| Cohort 2 High Dose | Experimental | 2 tablet of ASC41 (4 mg) for 52 weeks |
|
| Placebo tablet | Placebo Comparator | Placebo tablet for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2mg of ASC41 | Drug | ASC41 tablet administered orally once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change. | 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. ) | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Change from baseline in hepatic fat fraction assessed by MRI-PDFF | 24 and 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang | 310000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4mg of ASC41 (2 tablets of 2 mg ASC41) |
| Drug |
ASC41 tablets administered orally once daily. |
|
| Placebo | Drug | Placebo tablets administered orally once daily. |
|
| 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 |
| Plasma pharmacokinetics - Peak Plasma Concentration (Cmax) | Measured after administration | 1 and 15 Days |
| 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 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided