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

Inclusion Criteria:

1. Written informed consent

2. Male or female 18-75 years

3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on centralpathology evaluation of a liver biopsy during screening

4. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on eachsubcomponent score based on central pathology evaluation (steatosis [0-3],lobular inflammation [0-3], and hepatocyte ballooning [0-2])

5. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis stagingsystem based on central pathology evaluation

6. Subject agrees to have a liver biopsy performed during the screening period (if nobiopsy within the preceding 6 months is available) and at 24 weeks of treatment

7. BMI ≥ 27.0 kg/m2

8. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimenfor their T2D for at least 90 days prior to screening

9. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American HeartAssociation 2005)

10. Liver fat content by MRI-PDFF ≥ 8%

Exclusion Criteria:

1. Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6months prior to screening

2. History or clinical evidence of Type 1 diabetes mellitus

3. Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia

4. Liver conditions:

5. History of cirrhosis or complications of cirrhosis, including but not limitedto variceal bleeding, encephalopathy, or ascites

6. Documented causes of chronic liver disease other than NASH

7. ALT or AST laboratory values > 5 × ULN