Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery

Inclusion Criteria

• Age ≥18 years
• Undergoing bariatric surgery (Roux-en-Y or gastric sleeve only) as part of clinical care.
• Negative human chorionic gonadotropin (hCG) level (female participants who become pregnant during the study will be withdrawn)
• For nonalcoholic steatohepatitis (NASH) participants - FibroScan: Controlled Attenuation Parameter (CAP) 290 db/m and Vibration-Controlled Transient Elastography (VCTE) 8 kilopascal (kPa). For participants who meet FibroScan criteria, inclusion will require MRI-PDFF ≥8%; MRE: ≥2.7 kPa.
• For NAFLD or normal participants - FibroScan: No requirement for minimum CAP level and VCTE 12; Histological presence of cirrhosis on a prior biopsy.
• Human Immunodeficiency Virus (HIV) infection, defined as presence of HIV antibody
• Diagnosis of type 1 diabetes mellitus
• Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
• Use of drugs historically associated with non-alcoholic fatty liver disease (NAFLD) for 1 month in the previous year prior to Visit 3 (day of Surgery); examples include: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins
• Subjects with history of severe claustrophobia impacting ability to perform MRI during the study without mild sedation/treatment with an anxiolytic
• Subjects who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos
• Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and 500-pound weight limit) based on Investigator's judgment at screening
• Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images without mild sedation/treatment with an anxiolytic
• Subjects with any anatomical or pathological abnormality that would either preclude or tend to confound the analysis of study data, including any clinically significant abnormal findings on the MRI obtained at Screening Visit 2.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening Visit 1 (participants may not donate blood any time during the study, through the final study visit)
• Known history or suspected hypersensitivity to human serum albumin, or its preparations.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study