Intervention: Cenicriviroc
Trial phase: Phase 3
SMILES: CCCCOCCOc1ccc(-c2ccc3c(c2)/C=C(/C(=O)Nc2ccc([S@@+]([O-])Cc4cncn4CCC)cc2)CCCN3CC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1180
Group description: Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Eligibility criteria:
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 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
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 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 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).