Cholic Acid for Hepatic Steatosis in Lipodystrophy

Phase 2 Completed 18 enrolled University of Texas Southwestern Medical Center FDA Office of Orphan Products Development · collab

RandomizedCrossoverTriple-blindTreatment

Summary

To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.

Timeline

Start: 2006-04
Primary completion: 2011-04
Completion: 2011-04

Publications

Results Ahmad Z, Subramanyam L, Szczepaniak L, Simha V, Adams-Huet B, Garg A. Cholic acid for hepatic steatosis in patients with lipodystrophy: a randomized, controlled trial. Eur J Endocrinol. 2013 Apr 15;168(5):771-8. doi: 10.1530/EJE-12-0969. Print 2013 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cholic Acid	Small molecule	15 mg/kg	Oral

Cholic Acid for Hepatic Steatosis in Lipodystrophy

Summary

Timeline

Publications

Drugs

Indications