Status:
TERMINATED
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Nonalcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04766476
Start Date
February 24 2021
End Date
August 12 2021
Last Update
June 9 2022
Active Locations (19)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
Local Institution
Chandler, Arizona, United States, 85224
3
Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712
4
Local Institution
Boca Raton, Florida, United States, 33434