IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)

A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

Inclusion criteria

• Written informed consent
• Male or female 18-75 years
• Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening

• A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])
• NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation
• Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
• BMI ≥ 27.0 kg/m2
• Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
• Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)
• Liver fat content by MRI-PDFF ≥ 8%

Exclusion criteria

• Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening
• History or clinical evidence of Type 1 diabetes mellitus
• Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia
• Liver conditions:

• History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites
• Documented causes of chronic liver disease other than NASH
• ALT or AST laboratory values > 5 × ULN