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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Other: Placebo matching BMS-963272; Drug: BMS-963272

Study type: Interventional

Funder types: Industry

Identifiers

NCT04766476

MB006-025

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 3 patient groups, including a placebo group

Active Treatment (BMS-963272) Dosing Regimen 1

Experimental group

Treatment:

Drug: BMS-963272

Active Treatment (BMS-963272) Dosing Regimen 2

Experimental group

Treatment:

Drug: BMS-963272

Placebo

Placebo Comparator group

Treatment:

Other: Placebo matching BMS-963272