A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
NCT ID: NCT04766476
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2021-02-24
2021-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment (BMS-963272) Dosing Regimen 1
BMS-963272
Specified dose on specified days
Active Treatment (BMS-963272) Dosing Regimen 2
BMS-963272
Specified dose on specified days
Placebo
Placebo matching BMS-963272
Specified dose on specified days
Interventions
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BMS-963272
Specified dose on specified days
Placebo matching BMS-963272
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
Local Institution
Chandler, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Local Institution
Boca Raton, Florida, United States
RecioMed Clinical Research Network
Boynton Beach, Florida, United States
Local Institution
Miami, Florida, United States
Advanced Pharma - Miami
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Local Institution
Port Orange, Florida, United States
Local Institution
Bastrop, Louisiana, United States
Local Institution
Biloxi, Mississippi, United States
Local Institution
Kansas City, Missouri, United States
Local Institution
Chattanooga, Tennessee, United States
Local Institution
Germantown, Tennessee, United States
Pinnacle Clinical Research - Austin
Austin, Texas, United States
Local Institution
Edinburg, Texas, United States
Local Institution
McAllen, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
San Antonio, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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MB006-025
Identifier Type: -
Identifier Source: org_study_id
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