Phase 2
N=3
Effects of Human Leptin Replacement
Obesity · Metabolic Syndrome · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00657605 ↗Enrolled (actual)
3
Serious AEs
—
Results posted
Feb 2020
Primary outcome: Primary: Change in Weight — NA lbs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant methionyl human leptin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
NA | — |
| SECONDARY Change in Glucose Levels |
NA | — |
Summary
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.
Eligibility Criteria
Inclusion Criteria
- Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).
Exclusion Criteria
- Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception.
- Subjects with hemoglobin levels below 12 g/dl.
- Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.
Data sourced from ClinicalTrials.gov (NCT00657605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.