AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria:

• Male and female participants aged between 18-75 years
• Ability to understand and sign a written informed consent form (ICF)
• Histological evidence of NASH based on central reading of the Screening biopsy
• Participants included in Part 1 must have histopathological evidence of Stage 2 or 3liver fibrosis per the NASH CRN System based on central reading of the Screeningbiopsy slides. Participants newly randomized in Part 2 must have histological evidenceof Stage 3 liver fibrosis per the NASH CRN System, based on central reading of theScreening period biopsy slides. Historical biopsy can be used, provided the criterialisted on Item 3a above are fulfilled.
• Females of childbearing potential and males participating in the study must agree touse at least 2 approved methods of contraception throughout the duration of the studyand for 30 days after stopping study drug. Females who are postmenopausal must havedocumentation of cessation of menses for ≥12 months and serum follicle-stimulatinghormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.

Exclusion Criteria:

• Inability to undergo a liver biopsy
• Hepatitis B surface antigen (HBsAg) positive
• Hepatitis C antibody (HCVAb) positive
• Human immunodeficiency virus (HIV)-1 or HIV-2 infection
• Prior or planned liver transplantation
• Other known causes of chronic liver disease
• History or presence of cirrhosis and/or hepatic decompensation including ascites,hepatic encephalopathy or variceal bleeding
• Alcohol consumption greater than 21 units/week for males or 14 units/week for females
• Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males andfemales at Screening
• Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
• Hemoglobin A1c (HbA1c) >10% at Screening
• Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
• Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2according to the Modification of Diet in Renal Disease (MDRD) equation
• Platelet count <100,000/millimeter (mm)^3
• Total bilirubin >1.5 milligram (mg)/dL
• International normalized ratio (INR) >1.3
• Model of end stage liver disease (MELD) score >12
• Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (includinggastric banding and sleeve surgery)
• History of malignancy within the past 5 years or ongoing malignancy other than basalcell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
• Active, serious infections that require parenteral antibiotic or antifungal therapywithin 30 days prior to Screening Visit
• Clinically significant cardiovascular or cerebrovascular disease within the past 3months
• Females who are pregnant or breastfeeding
• Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeuticagents and immunomodulating agents (eg, interleukins, interferons, cyclosporine,tacrolimus) except for vaccines or short-term corticosteroids
• Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucosecotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 monthsprior to the Screening period liver biopsy. Participants on a stable therapy with aGLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for atleast 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be onstable therapy for at least 6 months prior to the day historical liver biopsy wasperformed).