Current partner codePEPTIDESDE
NCT00677313·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

41

Locations

5

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

metreleptin

metreleptin injection

Timeline

From registration to results.

  1. First posted

    May 14, 2008

  2. Study start

    Mar 2009

  3. Primary completion

    Jan 2015

  4. Study completion

    Jan 2015

  5. Results posted

    Not reported

  6. Registry updated

    Apr 30, 2015

Outcomes

What the study measures.

Primary outcomes

To provide metreleptin, an investigational medication, under a treatment protocol to subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia

Time frame · open ended

Secondary outcomes

To monitor the safety and tolerability of metreleptin in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia

Time frame · open ended

Information on the efficacy of metreleptin as assessed by its effects on fasting triglyceride concentrations, HbA1c, and fasting glucose concentrations in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia

Time frame · open ended

Eligibility

Who can take part.

Minimum age
5 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

5 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Santa Barbara, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Ann Arbor, Michigan, United States

Local Institution

Reno, Nevada, United States

Research Site

Greenville, North Carolina, United States

Related trials

More studies on Metreleptin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.