CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
Recombinant methionyl human leptindrug
Likely dose
Recombinant methionyl human leptin 0.04 mg/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/NCT00659828
NCT00659828Phase 2Completed
CompareCT.gov

Effects of Leptin Replacement in Children

University of Miami·interventional·Posted Apr 16, 2008·Updated Feb 13, 2020

In Brief

A Phase 2 clinical trial evaluating Recombinant methionyl human leptin for Obesity and 2 related conditions. Completed, enrolled 1 participant across 1 site.

Detailed Summary

To assess the endocrine and immune effects of leptin replacement in leptin-deficient children, from a consanguineous family. The hypothesis is that leptin replacement will have significant effects on endocrine function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Metabolic Syndrome, Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 16, 2008
Enrollment StartJun 1, 2005
Primary CompletionApr 16, 2010
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.2 years ago

Interventions

Recombinant methionyl human leptindrug

Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.