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BMS-963272 for Non-alcoholic Fatty Liver Disease
Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 15, day 29, day 57, and day 84
Awards & highlights
Summary
This trial is testing a new drug called BMS-963272 to see if it is safe and well-tolerated in people with severe liver disease. The study focuses on those with nonalcoholic fatty liver disease (NAFLD) and a high chance of advanced fibrosis.
Eligible Conditions
- Non-alcoholic Fatty Liver Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 15, day 29, day 57, and day 84
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 15, day 29, day 57, and day 84
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
+12 moreSecondary outcome measures
Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax)
Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment (BMS-963272) Dosing Regimen 2Experimental Treatment1 Intervention
Group II: Active Treatment (BMS-963272) Dosing Regimen 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-963272
2019
Completed Phase 1
~160
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,740 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
895 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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