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

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