Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
| Condition(s) | Nonalcoholic Steatohepatitis (NASH) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH |
| Who can participate | Inclusion Criteria: 1. Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F4 (compensated cirrhosis, Child-Pugh A, score ≤6) NASH. Limit F1 fibrosis to ≤ 20% of total subject population. 2. Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A). 3. Body mass index (BMI) \> 23 kg/m2 4. Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening. 5. Biopsy-proven NASH confirmed by a central pathologist. Must have had a liver biopsy either during the screening period or a historical biopsy conducted within the last 6 months prior to pre-screening with fibrosis stage 1 to 4 (F score, F1-F4) and a non-alcoholic fatty liver disease (NAFLD) activity score |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Polaris Group |
| Locations | Chiayi City, Taiwan, Taiwan; Kaohsiung, Taiwan, Taiwan; Kaohsiung, Taiwan, Taiwan; Kaohsiung, Taiwan, Taiwan; Keelung, Taiwan, Taiwan; Tainan, Taiwan, Taiwan (+4 more sites) |
| Start date | 2023-09-13 |
| NCT ID | NCT05842512 |
| Official listing | https://clinicaltrials.gov/study/NCT05842512 |