A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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