A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
Phase 1
Terminated
- Conditions
- Nonalcoholic Fatty Liver Disease
- Interventions
- Other: Placebo matching BMS-963272
- Registration Number
- NCT04766476
- Lead Sponsor
- Bristol-Myers Squibb
- 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 of advanced fibrosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo matching BMS-963272 - Active Treatment (BMS-963272) Dosing Regimen 1 BMS-963272 - Active Treatment (BMS-963272) Dosing Regimen 2 BMS-963272 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 166 days Incidence of serious adverse events (SAEs) Up to 166 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 166 days Incidence of clinically significant changes in vital signs: Heart rate Up to 166 days Incidence of clinically significant changes in physical examination findings Up to 166 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 166 days PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval Up to 166 days QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 166 days QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval Up to 166 days QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test Up to 166 days Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 166 days Incidence of clinically significant changes in clinical laboratory results: Coagulation tests Up to 166 days Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 46 days Incidence of clinically significant changes in clinical laboratory results: Liver function tests Up to 166 days Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests Up to 166 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) Day 1 and Day 84 Trough observed plasma concentration (Ctrough) Day 1, Day 15, Day 29, Day 57, and Day 84 Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax) Day 1 and Day 84 Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax) Day 1 and Day 84
Trial Locations
- Locations (7)
Arizona Liver Health - Tucson
🇺🇸Tucson, Arizona, United States
Pinnacle Clinical Research - Austin
🇺🇸Austin, Texas, United States
Local Institution
🇺🇸San Antonio, Texas, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Advanced Pharma - Miami
🇺🇸Miami, Florida, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
RecioMed Clinical Research Network
🇺🇸Boynton Beach, Florida, United States