A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
NCT03486899 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197
Last updated 2022-09-09
Summary
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).
Conditions
- Liver Fibrosis
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Nonalcoholic Steatohepatitis
Interventions
- DRUG
-
BMS-986036
Specified dose on specified days.
- OTHER
-
Placebo
Specified dose on specified days.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-19
- Primary Completion
- 2020-09-14
- Completion
- 2021-08-17
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
More Related Trials
-
A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body
NCT02538874 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
NCT04766476 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
NCT03445208 ·Status: COMPLETED ·Phase: PHASE1
-
6-week Safety and PD Study in Adults With NAFLD
NCT03256526 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT02912260 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2a Study of HPG1860 in Subjects With NASH
NCT05338034 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT05809934 ·Status: COMPLETED ·Phase: PHASE2
-
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
NCT03611101 ·Status: COMPLETED
-
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
NCT04483947 ·Status: COMPLETED ·Phase: PHASE1
-
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
NCT03674476 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT01694849 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT04171765 ·Status: TERMINATED ·Phase: PHASE2
-
2-Week Study In People With Nonalcoholic Fatty Liver Disease
NCT03513588 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
NCT05877547 ·Status: COMPLETED ·Phase: PHASE2
-
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT04321343 ·Status: COMPLETED ·Phase: PHASE2
-
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
NCT04906421 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Healthy Adults Evaluating PF-07202954
NCT04857437 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
NCT04583423 ·Status: TERMINATED ·Phase: PHASE2
-
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
NCT03437720 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02443116 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
NCT04048876 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT02854605 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate MET642 in Patients With NASH
NCT04773964 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT03900429 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3