CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
r-metHuLeptindrug
Likely dose
r-metreleptin in 3 different doses (specific doses not stated)AI-extracted
Key inclusion· 4
  • ✓Healthy men with BMI <25 kg/m²
  • ✓Overweight otherwise healthy men with BMI >27 kg/m²
  • ✓Healthy lean women with BMI <25 kg/m²
  • ✓Overweight otherwise healthy women with BMI >27 kg/m²
Key exclusion· 6
  • ✕History of anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, or hypogonadism
  • ✕History of malabsorption, malnourishment, hypo- or hyperthyroidism, hypercortisolism
  • ✕History of alcoholism or drug abuse, or eating disorders
  • ✕On medications known to affect hormone levels (glucocorticoids, anti-seizure medications, thyroid hormones)

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

Search/NCT00140205
NCT00140205Phase 1Completed
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Pharmacokinetics of Leptin Administration During Fasting

Beth Israel Deaconess Medical Center·interventional·Posted Sep 1, 2005·Updated Nov 2, 2018

In Brief

A Phase 1 clinical trial evaluating r-metHuLeptin for Energy Deficiency Due to Short-term Fasting. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnergy Deficiency Due to Short-term Fasting
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 1CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartFeb 1, 2001
Primary CompletionJun 1, 2004
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

r-metHuLeptindrug

r-metreleptin was given in 3 different dose in fed and fasting states