A 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: BMS-986036; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02413372

MB130-045

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).

Enrollment: 184 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

---

184 participants in 3 patient groups, including a placebo group

Treatment Group A: BMS-986036

Experimental group

Description:

Administered as specified on specified days

Treatment:

Drug: BMS-986036

Drug: BMS-986036

Treatment Group B: BMS-986036

Experimental group

Description:

Administered as specified on specified days

Treatment:

Drug: BMS-986036

Drug: BMS-986036

Treatment Group C: Placebo

Placebo Comparator group

Description:

Administered as specified on specified days

Treatment:

Drug: Placebo