Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Clinical diagnosis of FPL plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia.
- Diagnosis of FLP is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (≤ 10 mm) and women (≤ 22 mm), and at least 1 of the following:
- Genetic diagnosis of familial PL (e.g., mutations in LMNA, PPAR-γ, AKT2, CIDEC, PLIN1 genes)
-Family history of FPL or family history of abnormal and similar fat distribution plus 1 Minor Criteria
-2 Minor Criteria (In the absence of FPL-associated genetic variant or family history) and BMI< 35 kg/m2
- Requirement for high doses of insulin, e.g., requiring ≥ 200 U/day, ≥ 2 U/kg/day, or currently taking U-500 insulin
- Presence of acanthosis nigricans on physical examination
- Evidence/history of polycystic ovary syndrome (PCOS) or PCOS-like symptoms (hirsutism, oligomenorrhea, and/or polycystic ovaries)
- History of pancreatitis associated with hypertriglyceridemia
- Evidence of non-alcoholic fatty liver disease
- Hepatomegaly and/or elevated transaminases in the absence of a known cause of liver disease or radiographic evidence of hepatic steatosis (e.g., on ultrasound or CT)
- Diagnosis of Type 2 diabetes mellitus as defined by the American Diabetes Association Standards of Medical Care in Diabetes 2015) made at least 12 weeks prior to the Screening visit, and 2 of the following:
- on standard-of-care anti-diabetic therapy, and
- HbA1c ≥ 7% to ≤ 10% at Screening.
- Hypertriglyceridemia is defined as Fasting TG levels ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening and Qualification visit.
- If the fasting TG value at Screening and/or Qualification visit is < 500 mg/dL (< 5.7 mmol/L) but ≥ 350 mg/dL (≥ 4.0 mmol/L) up to 2 additional tests may be performed in order to qualify
- A diagnosis of generalized lipodystrophy
- A diagnosis of acquired partial lipodystrophy
- Acute pancreatitis within 4 weeks of Screening
- History within 6 months of Screening of acute or unstable cardiac ischemia (myocardial infarction, acute coronary syndrome, new onset angina), stroke, transient ischemic attack, or unstable congestive heart failure requiring a change in medication
- Major surgery within 3 months of Screening
- Treatment with Metreleptin within the last 3 months prior to Screening
- Previous treatment with ISIS-APOCIIIRx