A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
NCT03486912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2022-10-13
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 liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).
Conditions
- Hepatic Cirrhosis
- 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
- 2018-06-12
- Primary Completion
- 2020-10-08
- Completion
- 2021-09-14
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
More Related Trials
-
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
-
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT02912260 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
6-week Safety and PD Study in Adults With NAFLD
NCT03256526 ·Status: COMPLETED ·Phase: PHASE2
-
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
NCT03611101 ·Status: COMPLETED
-
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
NCT04906421 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2a Study of HPG1860 in Subjects With NASH
NCT05338034 ·Status: UNKNOWN ·Phase: PHASE2
-
2-Week Study In People With Nonalcoholic Fatty Liver Disease
NCT03513588 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
NCT04483947 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
NCT03674476 ·Status: COMPLETED ·Phase: PHASE1
-
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
-
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02443116 ·Status: COMPLETED ·Phase: PHASE2
-
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT04321343 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Healthy Adults Evaluating PF-07202954
NCT04857437 ·Status: COMPLETED ·Phase: PHASE1
-
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
NCT03061721 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
NCT06920043 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate MET642 in Patients With NASH
NCT04773964 ·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
-
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
NCT03912532 ·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
-
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
NCT04583423 ·Status: TERMINATED ·Phase: PHASE2