Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis. (TANDEM)

Inclusion Criteria:

Written informed consent Male and female patients 18 years or older (at the time of the
screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440
lb) to participate in the study.

Able to communicate well with the investigator, to understand and comply with the
requirements of the study.

Adequate liver biopsy sample for evaluation by Central Reader. Presence of NASH as
demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3,
demonstrated on liver biopsy during the screening period. Alternatively, a historical
biopsy can be used if performed within 6 months prior to screening.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of enrollment or within 30 days
whichever is longer.

History of hypersensitivity to any of the study drugs or its excipients or to drugs of
similar chemical classes.

Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or other
FXR agonist.

Participated in a clinical trial and treated with any investigational product being
evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening.

Patients taking medications prohibited by the protocol. History of treated or untreated
malignancy of any organ system, other than localized basal cell carcinoma of the skin or
treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether
there is evidence of local recurrence or metastases .

Pregnant or nursing (lactating) women. Women of child-bearing potential. Current or history
of significant alcohol consumption for a period of more than 3 consecutive months within 1
year prior to screening (significant alcohol consumption is defined as more than 20 g/day
in females and more than 30 g/day in males, on average) and/or a score on the modified
AUDIT questionnaire ≥ 8.

Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug
abuse, within the last 6 months prior to randomization.

Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as
HbA1c ≥ 9% at screening Clinical evidence of hepatic decompensation or severe liver
impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR
less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver
transplantation or planned liver transplant. Known positivity for HIV. History or current
diagnosis of ECG abnormalities indicating significant risk of safety for the patient to
participate.

History of inflammatory bowel disease. Patients who are not candidates for liver biopsy.
Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients
with an abnormal platelet count (referring to reference ranges from the central lab).