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

NCT04766476 | Terminated Phase 1 FDA Drug

• 1 other identifier: MB006-025
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 19

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.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

BMS-963272; Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH); Phase 1b

Outcome Measures

Primary Outcomes (15)

• 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

  PR interval: The time from the onset of the P wave to the start of the QRS complex

  Up to 166 days

• 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

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

Study Arms (3)

Active Treatment (BMS-963272) Dosing Regimen 1

EXPERIMENTAL

Drug: BMS-963272

Active Treatment (BMS-963272) Dosing Regimen 2

EXPERIMENTAL

Drug: BMS-963272

Placebo

PLACEBO COMPARATOR

Other: Placebo matching BMS-963272

Interventions

BMS-963272 DRUG

Specified dose on specified days

Active Treatment (BMS-963272) Dosing Regimen 1; Active Treatment (BMS-963272) Dosing Regimen 2

Placebo matching BMS-963272 OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (19)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Local Institution

Chandler, Arizona, 85224, United States

Location

Arizona Liver Health - Tucson

Tucson, Arizona, 85712, United States

Location

Local Institution

Boca Raton, Florida, 33434, United States

Location

RecioMed Clinical Research Network

Boynton Beach, Florida, 33472, United States

Location

Local Institution

Miami, Florida, 33014, United States

Location

Advanced Pharma - Miami

Miami, Florida, 33147, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Local Institution

Port Orange, Florida, 32127, United States

Location

Local Institution

Bastrop, Louisiana, 71220, United States

Location

Local Institution

Biloxi, Mississippi, 39532, United States

Location

Local Institution

Kansas City, Missouri, 64131, United States

Location

Local Institution

Chattanooga, Tennessee, 37421, United States

Location

Local Institution

Germantown, Tennessee, 38138, United States

Location

Pinnacle Clinical Research - Austin

Austin, Texas, 78757, United States

Location

Local Institution

Edinburg, Texas, 78539, United States

Location

Local Institution

McAllen, Texas, 78504, United States

Location

Local Institution

San Antonio, Texas, 78215, United States

Location

Local Institution

San Antonio, Texas, 78229, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: February 24, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

US (19)