Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial) (IMPACT)
Non-Alcoholic Steatohepatitis (NASH)
About this trial
This is an interventional treatment trial for Non-Alcoholic Steatohepatitis (NASH)
Eligibility Criteria
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
Sites / Locations
- Altimmune Clinical Study SiteRecruiting
- Altimmune Clinical Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Pemvidutide 1.2 mg (n=38)
Pemvidutide 1.8 mg (n=76)
Placebo (n=76)