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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: BMS-986036

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400163

MB130-045 A

Details and patient eligibility

About

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)

Enrollment: 3 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Treatment Group D:

Experimental group

Description:

Administered as specified on specified days

Treatment:

Drug: BMS-986036

Treatment Group E:

Placebo Comparator group

Description:

Administered as specified on specified days

Treatment:

Drug: Placebo