Status:
ACTIVE_NOT_RECRUITING
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Lipodystrophy
Diabetes
Eligibility:
All Genders
6-98 years
Phase:
PHASE3
Brief Summary
Background: \- Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metrelept...
Detailed Description
Leptin is an adipocyte-derived hormone that can be thought of as a signal from adipose tissue to the rest of the body conveying information about long-term nutritional status. Patients with the very r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 6 months.
- Generalized lipodystrophy (either congenital or acquired).
- Those who cannot obtain metreleptin through approved or compassionate use mechanisms in their home country.
- EXCLUSION CRITERIA:
- Availability of metreleptin to the patient either as an approved drug, or through local compassionate use or expanded access programs.
- Known HIV infection or HIV-associated lipodystrophy.
- Any medical condition or medication that will increase risk to the subject.
- Current alcohol or substance abuse.
- Subjects who have a known hypersensitivity to E. coli derived proteins (as leptin is derived from such proteins).
Exclusion
Key Trial Info
Start Date :
October 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02262832
Start Date
October 9 2014
End Date
July 31 2027
Last Update
December 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892