AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of
improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research
network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Subjects from Part 1
will continue into Part 2 and additional subjects will be newly randomized in Part 2 to
determine long-term clinical outcomes composed of histopathologic progression to cirrhosis,
liver-related clinical outcomes, and all-cause mortality.

Inclusion Criteria:

1. Male and female subjects aged between 18-75 years

2. Ability to understand and sign a written informed consent form (ICF)

3. Histological evidence of NASH based on central reading of the Screening biopsy

4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on
central reading of the Screening biopsy slides

5. Females of childbearing potential and males participating in the study must agree to
use at least 2 approved methods of contraception throughout the duration of the study
and for 30 days after stopping study drug. Females who are postmenopausal must have
documentation of cessation of menses for ≥ 12 months and serum follicle-stimulating
hormone (FSH) ≥ 30 mU/mL at Screening.

Exclusion Criteria:

1. Inability to undergo a liver biopsy

2. Hepatitis B surface antigen (HBsAg) positive

3. Hepatitis C antibody (HCVAb) positive

4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection

5. Prior or planned liver transplantation

6. Other known causes of chronic liver disease

7. History or presence of cirrhosis and/or hepatic decompensation including ascites,
hepatic encephalopathy or variceal bleeding

8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females

9. AST > 200 IU/L in males and females at Screening

10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening

11. HbA1c > 10% at Screening

12. Serum albumin < 3.5 g/dL

13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the
Modification of Diet in Renal Disease (MDRD) equation

14. Platelet count < 100,000/mm3

15. Total bilirubin > 1.5 mg/dL

16. International normalized ratio (INR) > 1.3

17. Model of end stage liver disease (MELD) score > 12

18. Weight reduction through bariatric surgery in the past 5 years or planned during the
conduct of the study (including gastric banding)

19. History of malignancy within the past 5 years or ongoing malignancy other than basal
cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma

20. Active, serious infections that require parenteral antibiotic or antifungal therapy
within 30 days prior to Screening Visit

21. Clinically significant cardiovascular or cerebrovascular disease within the past 3
months

22. Females who are pregnant or breastfeeding

23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic
agents and immunomodulating agents

24. Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4
(DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a
thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the
Screening liver biopsy