drugset / Trial / NCT01094158
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Phase 2
Completed
60 enrolled
Galmed Medical Reserch
Beilinson Hospital, Petach Tikva,Israel · collabHadassah Medical Organization · collabHillel Yaffe Medical Center · collabHoly Family Hospital, Nazareth, Israel · collabKaplan Hospital ,Rehovot,Israel · collabMeir Medical Center · collabRambam Health Care Campus · collabSoroka Hospital,Beer Sheva,Israel · collabTel-Aviv Sourasky Medical Center · collabThe Lady Davis Carmel Medical Center · collabZiv Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment. Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-11
- Completion
- 2012-01
Publications
- Background Leikin-Frenkel A, Goldiner I, Leikin-Gobbi D, Rosenberg R, Bonen H, Litvak A, Bernheim J, Konikoff FM, Gilat T. Treatment of preestablished diet-induced fatty liver by oral fatty acid-bile acid conjugates in rodents. Eur J Gastroenterol Hepatol. 2008 Dec;20(12):1205-13. doi: 10.1097/MEG.0b013e3282fc9743.
- Background Gilat T, Leikin-Frenkel A, Goldiner I, Juhel C, Lafont H, Gobbi D, Konikoff FM. Prevention of diet-induced fatty liver in experimental animals by the oral administration of a fatty acid bile acid conjugate (FABAC). Hepatology. 2003 Aug;38(2):436-42. doi: 10.1053/jhep.2003.50348.
- Safadi R, Konikoff FM, Mahamid M, Zelber-Sagi S, Halpern M, Gilat T, Oren R; FLORA Group. The fatty acid-bile acid conjugate Aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2085-91.e1. doi: 10.1016/j.cgh.2014.04.038. Epub 2014 May 9.