In January 2003, Amylin completed the acquisition from Restoragen, Inc. of rights to a Phase 2 program utilizing continuous infusion of glucagon-like peptide 1, or GLP-1, targeted for the treatment of congestive heart failure (CHF) in patients ineligible for transplant. GLP-1 is a naturally occurring hormone produced in the intestines in response to food intake.

Results were reported from an initial Phase 2 exploratory study in July 2003. This open-label study included 14 subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure, all of whom received study medication. Subjects showed general improvement in a composite score designed to quantify quality of life and cardiac function while receiving study medication. The score returned to baseline when medication was discontinued. The severity of heart failure, as indicated by NYHA class, also improved during AC2592 administration. The most common adverse event was mild to moderate nausea.

In late 2004, Amylin submitted an Investigational New Drug application (IND) to the FDA and initiated an additional Phase 2 study in subjects with NYHA Class III and IV congestive heart failure.