Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ADI-PEG20

    Drug

    Treatment for NASH

  • Placebo

    Other intervention

    Treatment for NASH

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Drug: ADI-PEG 20Experimental treatment 1 intervention
Group B: Drug: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Determine Efficacy of ADI-PEG 20 vs Placebo in the treatment of fatty liver as assessed by change in hepatic fat fraction

Evaluate absolute change from baseline in hepatic fat fraction assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 24

Time frame
24 Weeks

Secondary outcomes

1

Assess the Efficacy of ADI-PEG 20 vs Placebo reflected in the percent change from baseline in hepatic fat fraction at week 24

Evaluate percent change from baseline in hepatic fat fraction assessed by MRI-PDFF at Week 24

Time frame
24 Weeks
2

Assess the safety of ADI-PEG 20 in subjects with NASH

Evaluate the change from baseline in ALT at Weeks 12 and 24.

Time frame
24 Weeks
3

Assess the safety and tolerability of ADI-PEG 20 in subjects with NASH

Laboratory tests and clinical adverse events

Time frame
24 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Polaris Group

Lead sponsor

Source ClinicalTrials.gov
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