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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04766476
• Other study ID #: MB006-025
• Status: Terminated
• Phase: Phase 1
• Start date: February 24, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Drug:
• BMS-963272
Specified dose on specified days

Other:
• Placebo matching BMS-963272
Specified dose on specified days

Locations

Country	Name	City	State
United States	Pinnacle Clinical Research - Austin	Austin	Texas
United States	Local Institution	Bastrop	Louisiana
United States	Local Institution	Biloxi	Mississippi
United States	Local Institution	Boca Raton	Florida
United States	RecioMed Clinical Research Network	Boynton Beach	Florida
United States	Local Institution	Chandler	Arizona
United States	Local Institution	Chattanooga	Tennessee
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Local Institution	Edinburg	Texas
United States	Local Institution	Germantown	Tennessee
United States	Local Institution	Kansas City	Missouri
United States	Local Institution	McAllen	Texas
United States	Advanced Pharma - Miami	Miami	Florida
United States	Local Institution	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Local Institution	Port Orange	Florida
United States	Local Institution	San Antonio	Texas
United States	Local Institution	San Antonio	Texas
United States	Arizona Liver Health - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		Up to 166 days
Primary	Incidence of serious adverse events (SAEs)		Up to 166 days
Primary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 166 days
Primary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 166 days
Primary	Incidence of clinically significant changes in physical examination findings		Up to 166 days
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval: The time from the onset of the P wave to the start of the QRS complex	Up to 166 days
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval	QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Up to 166 days
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	QT interval: Measured from the beginning of the QRS complex to the end of the T wave	Up to 166 days
Primary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval	QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	Up to 166 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test		Up to 166 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 166 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Coagulation tests		Up to 166 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 46 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Liver function tests		Up to 166 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests		Up to 166 days
Secondary	Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax)		Day 1 and Day 84
Secondary	Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax)		Day 1 and Day 84
Secondary	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
Secondary	Trough observed plasma concentration (Ctrough)		Day 1, Day 15, Day 29, Day 57, and Day 84

External Links

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