Study of ADI-PEG 20 Versus Placebo in Subjects With NASH

Sponsor
Polaris Group
Study ID
NCT05842512
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI-PEG20 — DRUG
    Treatment for NASH
  • Placebo — OTHER
    Treatment for NASH

Study Details

Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH

Key Dates

Start date
Sep 13, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: ADI-PEG 20
    Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)
  • Placebo Comparator: Drug: Placebo
    Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)

Primary Outcome Measure

Determine Efficacy of ADI-PEG 20 vs Placebo in the treatment of fatty liver as assessed by change in hepatic fat fraction [ Time Frame: 24 Weeks ]

Central Contacts

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