Leptin to Treat Lipodystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00005905
• Date of registration: 09/06/2000
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Leptin to Treat Lipodystrophy
• Scientific title: Efficacy of Leptin Replacement in Treatment of Lipodystrophy
• Date of first enrolment: June 2000
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00005905
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

All ethnic groups

Males and females

Age greater than 14 years

Clinically-significant lipodystrophy, identified by the study physician during the
physical examination as an absence of fat outside the range of normal variation and/or
identified as a disfiguring factor by the patient.

Circulating leptin levels less than 4.0 ng/ml in females and less than 3.0 ng/ml in males
as measured by Linco assay on at least 2 occasions.

Presence of at least one of the following metabolic abnormalities:

Presence of diabetes as defined by the 1997 ADA criteria: a) fasting plasma glucose
greater than or equal to 126 mg/dL, or b) 2 hour plasma glucose greater than or equal to
200 mg/dL following a 75 gram oral glucose load, or c) diabetic symptoms with a random
plasma glucose greater than or equal to 200 mg/dL.

Fasting insulin greater than 30 micrograms/ml;

Fasting hypertriglyceridemia greater than 200 mg/dl.

EXCLUSION

General: Pregnant women, women in their reproductive years who do not use an effective
method of birth control, women currently nursing or lactating within 6 weeks of having
completed nursing, and persons who are unable to provide informed consent will be excluded
from the study.

Exclusions for underlying disease likely to increase side effects or to hinder objective
data collection:

Known liver disease due to causes other than non-alcoholic steatohepatitis

Current alcohol or substance abuse

Psychiatric disorder impeding competence or compliance

Active tuberculosis

Use of anorexiogenic drugs

Other condition which in the opinion of the clinical investigators would impede completion
of the study

Subjects who have a known hypersensitivity to E. Coli derived proteins



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lipodystrophy

Intervention(s)

Drug: hu Leptin (A-100)

Secondary ID(s)

000146

00-DK-0146

Source(s) of Monetary Support

Please refer to primary and secondary sponsors