CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Leptin +1 moredrug
Likely dose
Leptin 0.03mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00896298
NCT00896298Phase 3Completed

Double-Blind, Placebo-Controlled Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

University of Texas Southwestern Medical Center·interventional·Posted May 11, 2009·Updated Mar 27, 2024

In Brief

A Phase 3 clinical trial evaluating Leptin and Placebo for Hypoleptinemia and 3 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2009
Enrollment StartApr 1, 2006
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 17.1 years ago

Interventions

Leptindrug

Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.

Placebodrug

Sugar pill