Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
ConditionNonalcoholic Steatohepatitis (NASH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPolaris Group
About this trial
Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
Eligibility criteria
Qualifiers
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.
Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).
Body mass index (BMI) > 23 kg/m2
Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.
Disqualifiers
Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
Type 1 and insulin-dependent Type 2 diabetes.
Poorly controlled hypertension (blood pressure [BP] > 160/100 mmHg).
Prior history of decompensated liver disease including ascites, hepatic encephalopathy (HE), or variceal bleeding.
Trial design
Treatments tested in this trial
- ADI-PEG20
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov