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

NCT03400163 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MB130-045 A
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Non-Alcoholic Steatohepatitis

Keywords

First Line Therapy; NASH

Outcome Measures

Primary Outcomes (11)

• Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16

  The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.

  From Day 1 to Day 112

• Number of Participants With Adverse Events (AEs)

  The number of participants with on-study AEs was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Serious Adverse Events (SAEs)

  The number of participants with on-study SAEs was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Injection Site Reactions

  The number of participants with on-study injection site reactions was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Adverse Events Leading to Discontinuation

  The number of participants with on-study AEs leading to discontinuation was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Deaths

  The number of deaths was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Marked Laboratory Abnormalities

  The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Vital Sign Abnormalities

  The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Electrocardiogram (ECG) Abnormalities

  The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.

  From first dose to date of last dose plus 30 days

• Number of Participants With Physical Examination Abnormalities

  The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.

  From first dose to date of last dose plus 30 days

• Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)

  The mean percent change in bone mineral density from baseline to day 112 reported for each arm.

  From Day 1 to Day 112

Secondary Outcomes (3)

• Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112

  From Day 1 to Day 112

• Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142

  From Day 1 to Day 142

• Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142

  From Day 1 to Day 142

Study Arms (2)

Treatment Group D:

EXPERIMENTAL

Administered as specified on specified days

Drug: BMS-986036

Treatment Group E:

PLACEBO COMPARATOR

Administered as specified on specified days

Drug: Placebo

Interventions

BMS-986036 DRUG

BMS-986036 20 mg QD

Treatment Group D:

Placebo DRUG

Placebo QD

Treatment Group E:

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Pegbelfermin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 17, 2018
• Study Start: May 8, 2015
• Primary Completion: January 18, 2017
• Study Completion: June 19, 2017
• Last Updated: February 26, 2021
• Results First Posted: February 19, 2020

Record last verified: 2021-02

Locations

US (2)