Amylin Pharmaceuticals Inc. (AMLN) announced findings from an ongoing clinical study or expanded access protocol that shows treatment with metreleptin, an investigational medication under evaluation for the treatment of diabetes and/or hypertriglyceridemia, or high levels of triglycerides in the bloodstream, in patients with rare forms of inherited or acquired lipodystrophy, reduced blood glucose and triglyceride levels.
The company said that the findings were presented in two separate posters at the Endocrine Society's 94th Annual Meeting and Expo (ENDO) in Houston, Texas.
The company noted that the findings from the first poster included data from an ongoing expanded access protocol of metreleptin administration in patients with rare forms of inherited or acquired lipodystrophy. The analysis included 19 patients with diabetes and/or high triglyceride levels who were diagnosed clinically with FPL, one of the major subtypes of lipodystrophy, without using a threshold leptin level as an eligibility criterion.
In patients with A1C =7% (14/19), A1C decreased by 0.4±0.6% at six months (n=10) and 1.0±0.7% at 12 months (n=7). In patients with triglyceride levels =200 mg/dL at baseline (12/19), triglyceride levels decreased by 31±28 mg/dL at six months (n=6) and 184±127 mg/dL at 12 months (n=5).
Fat tissue is a major endocrine organ producing important metabolic hormones such as leptin. People with lipodystrophy lack the required fat tissue for normal metabolic function. This can be partial, affecting select areas of the body, or generalized, affecting nearly the entire body. A lack of fat tissue can lead to relative deficiency of leptin.
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