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Recruiting

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease - MB006-025

Actualizada: 21 mayo, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-75

    Rango de edad

  • 20

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Active Treatment (BMS-963272) Dosing Regimen 1
Drug: BMS-963272
Experimental: Active Treatment (BMS-963272) Dosing Regimen 2
Drug: BMS-963272
Placebo Comparator: Placebo
Other: Placebo matching BMS-963272

Criterios clave de elegibilidad

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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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