MYALEPT delivered substantial reductions in fasting triglycerides, Hba1c and fasting glucose as early as 4 months, and sustained these results over 12 months

 

 

a Study design: An open-label, single-arm study evaluated MYALEPT treatment in 48 patients. Patients had to have congenital generalized lipodystrophy (CGL) or acquired generalized lipodystrophy (AGL) and diabetes mellitus, hypertriglyceridemia, and/or increased fasting insulin. Of the 48 patients enrolled, 32 (67%) had CGL, 16 (33%) had AGL, 36 (75%) were female, 22 (46%) were Caucasian, 10 (21%) were Hispanic, and 9 (19%) were Black. The median age at baseline was 15 years (range: 1-68 years), with 35 (73%) patients less than 18 years of age. The median fasting leptin concentration at basline was 0.7 ng/mL in males (range: 0.3-3.3 ng/mL) and 1.0 ng/mL in females (range: 0.3-3.3 ng/mL). The median duration of MYALEPT treatment was 2.7 years (range: 3.6 months-10.9 years).

b The n numbers across the 3 metabolic parameters—fasting tiglycerides (n=36), HbA1c (n=35/36) and fasting glucose (n=37)—differ from the total N number (N=48) because not all patients were able to contribute data to each parameter (fasting triglycerides, HbA1c and fasting glucose) and/or each time point (baseline and month 12).

c Fasting triglycerides: mg/dL (quartile 1, quartile 3); HbA1c: % ± standard deviation (SD); fasting glucose: mg/dL ± SD

d Mean reduction from baseline to month 12 was based on data from 35 patients. Absolute value at month 12 included an additional patient whose data at baseline were not captured. 

MYALEPT has been studied for over 10 years

The median duration of exposure in the clinical trial was 2.7 years with a range of 3.6 months to 10.9 years. Learn more about the safety of MYALEPT