For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria apply
Recruiting
