CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
leptindrug
Likely dose
leptin 0.01mg/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/NCT01275053
NCT01275053Phase 1Completed

In Vivo Leptin Signaling in Humans After Acute Leptin Administration

Beth Israel Deaconess Medical Center·interventional·Posted Jan 12, 2011·Updated Oct 17, 2017

In Brief

A Phase 1 clinical trial evaluating leptin for Lean and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this research study is to help us to better understand how leptin regulates blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells. Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an investigational drug and has not yet been approved by the Food and Drug Administration (FDA), will be administered to participants in this study. The expected duration of your participation is 3 study visits, which will be spread over 3-4 weeks. This study involves having fat and muscle biopsies after receiving leptin under local anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or Endocrinology exam room at the Beth Israel Deaconess Medical Center.

Study Details

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

Timeline

Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2011
Enrollment StartJul 1, 2002
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11.4 yearsPosted 15.5 years ago

Interventions

leptindrug

0.01mg/kg