drugset / Trial / NCT00896298

Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

NCT00896298

Phase 2/3 Completed 25 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

Timeline

Start
2006-04
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leptin Protein / enzyme biologic 0.02 mg/kg Subcutaneous
Comparator Leptin Protein / enzyme biologic 0.03 mg/kg Subcutaneous
Comparator Leptin Protein / enzyme biologic 0.04 mg/kg Subcutaneous