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Keep this study
Lead
Bristol-Myers Squibb
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Body mass index (BMI) ≥ 30 kg/m\^2
Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 10% as evaluated by central review
FibroScan-based transient elastography ≥ 9.9 kPa
Alanine aminotransferase (ALT): \> 30 U/L
If available, historical diagnosis of non-alcoholic steatohepatitis (NASH) according to NASH Clinical Research Network classification by liver biopsy within 6 months before screening will be recorded
Must agree to follow specific methods of contraception, if applicable
You may not be if
Women who are breastfeeding
Inability to tolerate the mixed meal or the testing conditions, oral medication, venipuncture and/or inadequate venous access
History or current diagnosis of cirrhosis, hepatocellular carcinoma (HCC), or hepatic decompensation
Recent history (within 2 years before screening) of drug or alcohol abuse or excessive alcohol intake, defined as 30 g/day (men) or 20 g/day (women)
Use of lipase inhibitors such as orlistat within 4 weeks before screening or during screening
Use of glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks before screening or during screening
Uncontrolled hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) during screening, unless discussed with the Medical Monitor
Glycated hemoglobin (HbA1c) ≥ 9.5%
NASH-modifying therapies including investigational therapies (e.g., obeticholic acid, ursodeoxycholic acid) within 90 days before screening or during screening
Medications for obesity within 12 weeks before screening, or during screening
If taking vitamin E at a dose ≥ 800 mg/day, the dose must be stable beginning at least 6 months before screening and should remain stable during screening
If taking a thiazolidinedione, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening
If taking a dipeptidyl peptidase (DPP)-4 inhibitor or other medications for diabetes, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening
If taking insulin, the dose may be altered by up to 10% within 12 weeks before screening and during the screening period
If taking a statin or other prescription or over-the-counter lipid-lowering drug, the dose must be stable beginning at least 6 weeks before screening and should remain stable during screening
Clareo Health | A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
