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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

Updated: 21 May, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 21

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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

Key Eligibility 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com