CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Leptin +1 moredrug
Likely dose
Not stated in 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/NCT01155180
NCT01155180Phase 2Completed

Leptin in the Maintenance of Reduced Body Weight

Beth Israel Deaconess Medical Center·interventional·Posted Jul 1, 2010·Updated Apr 7, 2017

In Brief

A Phase 2 clinical trial evaluating Leptin and Placebo for Obesity. Completed, enrolled 24 participants across 1 site.

Detailed Summary

You are invited to take part in a research study about the role of leptin (a fat cell hormone that normally circulates in the blood) on maintaining a reduced body weight. This study will also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used at rest), autonomic nervous function (the part of your brain that controls your heart rate and breathing), changes in body composition and your sense of appetite. Under normal conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and regulate energy usage and hormone levels. When obese individuals lose weight, their leptin levels go down, which may cause them to later regain the weight. This study will provide leptin as an investigational medication (not yet approved by the Food and Drug Administration) to increase the levels of the leptin hormone that normally circulates in your blood back to a normal range. We will see if this can help you to maintain your reduced body weight and improve your hormonal and metabolic function.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2010
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.0 years ago

Interventions

Leptindrug

Hormone - daily self injections for 6 months

Placebodrug

Placebo