studies

1268A AASLD ABSTRACTS HEPATOLOGY, October, 2015
long-term mortality compared to control obese NASH subjects.
Gene expression profiling of hepatic tissue in NASH subjects
revealed the induction of TNF-α /NF-κB and fibrogenic pathways
as potential targets.
Disclosures:
Francesco Negro - Advisory Committees or Review Panels: Bristol-Myers Squibb,
MSD, Gilead, AbbVie; Grant/Research Support: Gilead
Scott L. Friedman - Advisory Committees or Review Panels: Pfizer Pharmaceutical;
Consulting: Conatus Pharm, Exalenz, Genfit, Exalenz Biosciences, Eli Lilly PHarmaceuticals,
Fibrogen, Boehringer Ingelheim, Nitto Corp., Immune Therapeutics,
Synageva, Roche/Genentech Pharmaceuticals, DeuteRx, Abbvie, Novartis,
RuiYi, Kinemed, Sanofi Aventis, Takeda Pharmaceuticals, Nimbus Therapeutics,
Bristol Myers Squibb, Astra Zeneca, Sandhill Medical Devices, Galmed, Northern
Biologics, Enanta Pharmaceuticals, Regado Bioscience, Raptor Pharmaceuticals,
Teva Pharmaceuticals, Zafgen Pharmaceuticals, Merck Pharmaceuticals,
Debio Pharmaceuticals; Grant/Research Support: Galectin Therapeutics, Tobira
Pharm; Stock Shareholder: Angion Biomedica, Intercept Pharma
The following authors have nothing to disclose: Nicolas Goossens, Won-Min
Song, Minoa K. Jung, Philippe Morel, Shigeki Nakagawa, Xiaochen Sun, Anu
Venkatesh, Anna Koh, Jean-Louis Frossard, Laurent Spahr, Laura Rubbia-Brandt,
Emiliano Giostra, Yujin Hoshida
2175
Naltrexone/Bupropion Extended-Release 32 mg/360
mg significantly improves liver enzymes in obese/overweight
individuals with elevated liver enzymes
Allison Winokur 1 , Amy Halseth 2 , Claire Dybala 1 , Hung Lam 3 ,
Steve Chen 1 , Naga P. Chalasani 4 ; 1 Takeda Pharmaceuticals
U.S.A., Inc., Deerfield, IL; 2 Orexigen Therapeutics, Inc., La Jolla,
CA; 3 Takeda Development Center Americas, Inc., Deerfield, IL;
4 Division of Gastroenterology and Hepatology, Indiana University
School of Medicine, Indianapolis, IN
Background: Non-alcoholic fatty liver disease (NAFLD) can be
a consequence of obesity. Alanine aminotransferase (ALT) is
often increased in patients with NAFLD and is used as a measure
of liver dysfunction. NAFLD can improve with weight loss.
Aim: This posthoc analysis examined the effect of extendedrelease
naltrexone/bupropion (NB), approved in the US and
Europe for obesity management, on ALT in non-diabetic, obese
patients. Methods: Subjects from 3 Phase 3 studies who were
randomly assigned to receive NB or placebo (PBO), and who
remained in the trials for 56 weeks were included. NB subjects
had to lose at least 5% of their body weight at week 16 to
be included, consistent with prescribing information. Analyses
by baseline (BL) ALT quartile included change from BL in
ALT, % of subjects achieving a 25% or 50% reduction in ALT,
and % subjects achieving Prati criteria (≤19 IU/L for women;
≤30 IU/L for men) at Week 56. Results: Study population consisted
of 781 NB subjects (mean age 46 years, BMI 36 kg/
m 2 , 85% female, median ALT 22 IU/L) and 663 PBO subjects
(mean age 46 years, BMI 36 kg/m 2 , 84% female, median ALT
22 IU/L). NB responders completing 56 weeks of treatment
experienced significantly greater weight loss vs. PBO (-12.4%
vs. -2.7%, p