CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
r-metHuLeptin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Healthy lean women with BMI < 25 kg/m²
  • ✓Overweight otherwise healthy men with BMI > 27 kg/m²
  • ✓Overweight otherwise healthy women with BMI > 27 kg/m²
Key exclusion· 3
  • ✕History of illness affecting hormone concentrations: infectious diseases, renal or hepatic failure, type 1 or type 2 diabetes, cancer or lymphoma, hypogonadism, malabsorption or malnourishment, hypo- or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, anemia, or eating disorder
  • ✕Use of medications known to affect measured hormones: glucocorticoids, anti-seizure medications, and thyroid hormones
  • ✕Known history of anaphylaxis, anaphylactoid-like reactions, or hypersensitivity to E. coli–derived proteins

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

Search/NCT00140231
NCT00140231Phase 2Completed
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Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans

Beth Israel Deaconess Medical Center·interventional·Posted Sep 1, 2005·Updated Jun 7, 2017

In Brief

A Phase 2 clinical trial evaluating r-metHuLeptin and placebo for Fasting. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFasting
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR), Amgen

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartOct 1, 2002
Primary CompletionMar 1, 2011
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 20.8 years ago

Interventions

r-metHuLeptindrug

recombinant human leptin

placeboother

placebo (no active drug)