SCHOOL OF MEDICINE

Department of Medicine

IU Liver Research

Non-alcoholic fatty liver disease

 

Naga Chalasani, MD
Raj Vuppalanchi, MD

Relevant Investigators

 

Non-alcoholic fatty liver disease team


Non-alcoholic fatty liver disease (Galectin Studies) team

Non-alcoholic fatty liver disease is the buildup of fat in the liver that is NOT caused by drinking too much alcohol. People who have it do not have a history of heavy drinking. NAFLD is closely related to being overweight.


Current studies:

Bristom-Myers Squibb NASH Study
Enrolling: Yes
Duration: 1 year; 16 weeks on treatment
Primary Outcomes measured: Change in percent hepatic fat fraction (%) by Magnetic Resonance Imaging
Drug(s): BMS-986036, daily subcutaneous injection

Contact information:
Rachel Lee
317-278-6266
Lee352@iu.edu


NuSirt Non-alcoholic fatty liver disease
Enrolling: Yes
Duration: 18 weeks total
Primary Outcomes measured: Change in hepatic fat
Drug(s): Fixed-dose Leucine, Metformin, Sildenafil Cominations (NS-0200) or placebo, capsules twice a day

Contact information:
Rachel Lee
317-278-6266
Lee352@iu.edu


Intercept 303 NASH Study
Enrolling: No
Duration: Up to 6 years
Primary Outcomes measured: Change in hepatic fat
Drug(s): To evaluate the effect of Obeticholic Acid compated to placebo on liver histology in non-cirrhotic nonalcoholic steatohepatitis (NASH) subjects with stage 2 or 3 fibrosis by assessing:

  • Proportion of Obeticholic Aced treated patients relative to placebo achieving at least one state of liver fibrosis improvement  with no worsening of NASH
  • Proportion of Obeticholic Acid treated patients relative to placebo achieving NASH resolution with no worsening of liver fibrosis.

Contact information:
Rachel Lee
317-278-6266
Lee352@iu.edu


Gilead GS-US-384-1497 NASH Study
Enrolling: No
Duration: 36 weeks
Primary Outcomes measured: Adverse event profile:

  • Incidence of treatment-emergent serious adverse events
  • Incidence of worsening of treatment-emergent liver laboratory abnormalities for alanine aminotransferase (ALT) and aspartate aminotransferase (AST), defined as at least 1 toxicity grade increase from baseline\

Drug(s): GS-4997 alone or in combination with Simtuzumab

Contact information:
Sherrie Cummings
317-278-2481
shcummin@iu.edu


Galectin GT_026 The NASH-CX Trial
Enrolling: No
Duration: 67 weeks
Primary Outcomes measured: Evaluate the efficacy of GR MD 02 on reducing hepatic venous pressure gradient (HVPG) as a measure of portal pressure compared to placebo
Drug(s): GR-MD-02 in 2mg/kg body weight or 8 mg/kg body weight or placebo

Contact information:
Nina Garret
317-278-9245
Ninagarr@iu.edu


A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hyperension
Enrolling: Yes
Duration: 32 weeks; screening period of 6 weeks, double-blind treatment period of 24 weeks, follow-up period of 2 weeks
Primary Outcomes measured:
Drug(s): Emricasan tablet - 5mg, 25mg, 50mg or placebo

Contact information:
Charlene Jones
317-278-9215
Jones572@iu.edu

Nina Garrett
317-278-8245
ninagarr@iu.edu


Fibroscan with CAP
Enrolling: Yes
Duration: 1 visit

Contact information:
Regina Weber
317-278-3584
reginaw@iu.edu