Study Description

Brief summary:

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

• Condition or Disease:Nonalcoholic Steatohepatitis (NASH)
• Intervention/Treatment: Drug: BMS-986263
  Other: Placebo
• Phase: Phase 2

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 1. Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 2. Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 3. Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 4. Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 5. Change from baseline in collagen proportionate area (CPA) [ Time Frame: At 12 weeks ]
  
• Secondary Outcome Measures: 6. Incidence of Adverse Events (AEs) [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 8. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 9. Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 10. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 11. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 12. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 13. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 14. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 15. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 16. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to week 36 ]
  PR interval: The time from the onset of the P wave to the start of the QRS complex
• Secondary Outcome Measures: 17. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to week 36 ]
  QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
• Secondary Outcome Measures: 18. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to week 36 ]
  QT interval: Measured from the beginning of the QRS complex to the end of the T wave
• Secondary Outcome Measures: 19. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval [ Time Frame: Up to week 36 ]
  QTcB interval: Corrected QT interval using Bazett's formula (QTcB)
• Secondary Outcome Measures: 20. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to week 36 ]
  QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
• Secondary Outcome Measures: 21. Incidence of clinically significant changes in physical examination [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 22. Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan [ Time Frame: Up to week 36 ]
  
• Secondary Outcome Measures: 23. Plasma concentrations of small interfering ribonucleic acid (siRNA) [ Time Frame: Day 1 to week 12 ]
  
• Secondary Outcome Measures: 24. Plasma concentrations of di-retinamide-PEG-di-retinamide (DPD) [ Time Frame: Day 1 to week 12 ]
  
• Secondary Outcome Measures: 25. Plasma Concentrations of ({Bis[2-(tetradecanoyloxy)ethyl] carbamoyl}methyl)-(2-hydroxyethyl) dimethylazanium bromide (HEDC) [ Time Frame: Day 1 to week 12 ]
  
• Secondary Outcome Measures: 26. Plasma concentrations of lipid component (S104) [ Time Frame: Day 1 to week 12 ]
  

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 21 to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04267393 History of Changes
• Other Study ID Numbers: IM025-017, 2019-003932-22, U1111-1241-4762
• First Posted: February 12, 2020 Key Record Dates
• Last Update Posted: October 18, 2021
• Last Verified: October 2021
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Compensated cirrhosis
  NASH Liver Disease
  Nonalcoholic Steatohepatitis
• Additional relevant MeSH terms: Fibrosis
  Non-alcoholic Fatty Liver Disease Fatty Liver
  Liver Cirrhosis