Status:
COMPLETED
The Effects of Metreleptin in Congenital Leptin Deficiency
Lead Sponsor:
Northwestern University
Conditions:
Congenital Leptin Deficiency (Disorder)
Eligibility:
All Genders
18+ years
Brief Summary
This study has been designed to 1) provide access to metreleptin to the only two individuals in the US known to have congenital leptin deficiency (CLD) and 2) explore a variety of unanswered questions...
Detailed Description
Congenital leptin deficiency (CLD) is a rare autosomal recessive condition caused by a mutation in the leptin gene (LEP). This mutation leads to a severe deficiency in leptin, a hormone secreted prima...
Eligibility Criteria
Inclusion
- Diagnosis of congenital leptin deficiency
- Age 18 years or older
- Must agree to use contraception for the duration of treatment with metreleptin and for 6 months post-treatment completion.
Exclusion
- Presence of a clinically significant medical condition that could significantly affect the risk/benefit ratio for metreleptin treatment, as judged by the PI
- Known allergies to E. coli-derived proteins or hypersensitivity to any component of metreleptin treatment
Key Trial Info
Start Date :
June 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04063488
Start Date
June 20 2019
End Date
August 13 2021
Last Update
December 30 2021
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611