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

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 and females 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)\^2 according 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 (including gastric banding and sleeve surgery)
• •History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
• •Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
• •Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
• •Females who are pregnant or breastfeeding
• •Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents 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-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 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 on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).