An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-01-31

Brief Summary

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This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investigators with respect to identification of appropriate subjects for metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy data following metreleptin treatment in this population

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Detailed Description

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Conditions

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Lipodystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

metreleptin

Intervention Type DRUG

metreleptin injection

Interventions

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metreleptin

metreleptin injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is male or female ≥5 years old
* If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

1. Not breastfeeding
2. Negative pregnancy test result
3. Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
* Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
* Has been diagnosed with at least one of the following 2 metabolic disorders:

1. Diabetes Mellitus
2. Hypertriglyceridemia as defined by fasting triglyceride concentrations \>200 mg/dL
* If ≥18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements
* If \<18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child.

Exclusion Criteria

* Has been diagnosed with HIV infection
* Has known infectious liver disease
* Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No