The study showed statistically significant, progressive weight loss of 3.6 percent (3.5 kilograms) compared to placebo, according to Amylin, with no evidence of a plateau in effect at 16 weeks.

The weight loss was accompanied by a significant, progressive reduction in waist circumference -- a recognized marker of abdominal obesity and cardiovascular risk.

5 Percent Average Weight Loss at 16 Weeks

This blinded, placebo-controlled study included 204 obese subjects, 160 without diabetes and 44 with non-insulin-treated type 2 diabetes.

Study participants received pramlintide or placebo three times a day before meals for 16 weeks and were asked to maintain their usual diet and exercise routines.

Subjects in this study were able to tolerate higher doses of pramlintide than those previously evaluated in long-term diabetes studies, with approximately 90% progressing to 240 micrograms three times a day.

Subgroup analyses indicated that body weight reduction with pramlintide versus placebo was most pronounced in subjects with obesity class I (BMI of 30 to 35 kg/m2), who experienced an average weight loss of approximately 5 percent at 16 weeks.

Lifestyle Intervention Program

Pramlintide generally was well tolerated. The most common adverse event for pramlintide compared to placebo was mild, transient nausea, experienced by a minority of subjects. Weight loss in subjects who did not experience nausea was similar to that seen in those who did experience nausea.

"It is clear that islet hormones can have important effects on satiety and food intake," said Jeffrey Friedman, MD, PhD, Professor, Rockefeller University and Investigator, Howard Hughes Medical Institute.

Amylin submitted an Investigational New Drug application to the US Food and Drug Administration for the pramlintide obesity program earlier this year.

The company recently has begun enrolling a 16-week Phase 2 dose-ranging study in approximately 400 obese, non-diabetic subjects. This placebo-controlled study will evaluate three doses ranging up to 360 micrograms with twice and three times a day dosing regimens.

In addition to receiving either pramlintide or placebo, all subjects will participate in a lifestyle intervention program. Data from this study is expected to be available in the first half of 2006.