Clinical trial NCT02413372: A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Steatohepatitis
Keywords: First Line Therapy
NASH
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16
timeFrame: From Day 1 to Day 112
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Injection Site Reactions
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Deaths
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose to date of last dose plus 30 days
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: From first dose to date of last dose plus 30 days
measure: Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)
timeFrame: From Day 1 to Day 112
Secondary outcomes:
measure: Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
timeFrame: From Day 1 to Day 112
measure: Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142
timeFrame: From Day 1 to Day 142
measure: Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
timeFrame: From Day 1 to Day 142
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: University Of California, San Diego
state: California
city: Indianapolis
country: United States
facility: Indiana University Health - University Hospital
state: Indiana
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Chapel Hill
country: United States
facility: Unc Hospitals And Clinics
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc Center For Liver Diseases
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research PLLC
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sanyal A, Charles ED, Neuschwander-Tetri BA, Loomba R, Harrison SA, Abdelmalek MF, Lawitz EJ, Halegoua-DeMarzio D, Kundu S, Noviello S, Luo Y, Christian R. Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet. 2019 Dec 22;392(10165):2705-2717. doi: 10.1016/S0140-6736(18)31785-9. Epub 2018 Dec 13.