A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-08

Study Completion Date

2017-06-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

NCT02413372

Non-Alcoholic Steatohepatitis

COMPLETED PHASE2

Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

NCT04267393

Nonalcoholic Steatohepatitis (NASH)

TERMINATED PHASE2

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

NCT03486899

Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis

COMPLETED PHASE2

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

NCT03486912

Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) +1 more

COMPLETED PHASE2

A Study of Experimental Medication BMS-986036 Given to Healthy Participants

NCT03445208

Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Alcoholic Steatohepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group D:

Administered as specified on specified days

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

BMS-986036 20 mg QD

Treatment Group E:

Administered as specified on specified days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986036

BMS-986036 20 mg QD

Intervention Type DRUG

Placebo

Placebo QD

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female between 21 and 75 years old
* Body Mass Index (BMI) of 25 or more

Exclusion Criteria

* Chronic Liver disease other than NASH
* Uncontrolled diabetes
* Any major surgery within 6 weeks of screening
* Unable to self-administer under the skin injections
* Any bone trauma, fracture or bone surgery within 8 weeks of screening

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No