Amylin Pharmaceuticals, Inc.

Astrazeneca Pharmaceuticals LP

Leigh MacConell

Mark S Fineman

Kristin Taylor

Methods for reducing body weight, altering body composition, treating diabetes, reducing HbAand reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.

Methods for treating diabetes and reducing body weight

Provided herein are pharmaceutical formulations containing exendins, exendin agonists, or exendin analog agonists that are administered at therapeutic plasma concentration levels over a sustained period of time to lower total cholesterol levels; to lower LDL-cholesterol levels; to lower triglyceride levels; to treat dyslipidemia; to treat and slow the progression of atherosclerosis; and to treat, prevent, and reduce the risk of heart attacks and strokes in patients. In the pharmaceutical formulations and methods of the invention, the exendin may be exendin-4, an exendin-4 agonist, or an exendin-4 analog agonist. The pharmaceutical formulations may be polymer-based pharmaceutical formulations that may be administered once weekly. An exemplary pharmaceutical formulation comprises 5% (w/w) of exenatide, about 2% (w/w) of sucrose, and about 93% (w/w) of a poly(lactide-co-glycolide) polymer, wherein the poly(lactide-co-glycolide) polymer is in the form of microspheres encapsulating the exenatide.

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San Diego, CA, United States of America

Leigh MacConell