Amylin Pharmaceuticals on June 3rd presented early-stage results of a trial of their drug pramlintide that showed obese people lost an average of 7.7 pounds more than those taking a placebo, with no evidence that they were hitting a plateau at the end of the 16-week trial period.

Pramlintide is a synthetic analog of human amylin, a hormone known to play a role in the regulation of appetite and food intake.

It is same drug as Symlin, which the U.S. Food and Drug Administration earlier this year gave Amylin approval to sell as a therapy for people with type 1 and type 2 diabetes. Symlin helps people taking insulin better control their blood sugar.

The patients taking pramlintide for the obesity study were given about twice the dose of the people who take it in the form of Symlin, a company spokesperson said.

Researchers reported at the European Congress on Obesity (ECO) in Athens, Greece, that participants in the obesity trial also showed a significant and progressive reduction in their waist circumference, a recognized measure of abdominal obesity and cardiovascular risk.

Participants in this study included 204 obese subjects, 160 without diabetes and 44 with non-insulin-treated type 2 diabetes, who received pramlintide or a placebo three times a day before meals for 16 weeks and were asked to maintain their usual diet and exercise routines.

Researchers said body weight reduction with pramlintide was most pronounced in the most obese participants -- those with a body mass index (BMI) of between 30 and 35, who experienced an average weight loss of approximately 5 percent at 16 weeks.

Pramlintide was generally well tolerated. The most common adverse event for pramlintide compared to a placebo was mild, transient nausea, experienced by a minority of subjects, the researchers said.

"It is clear that islet hormones can have important effects on satiety and food intake," said Dr. Jeffrey Friedman, a researcher at the Howard Hughes Medical Institute.

Amylin submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration for the pramlintide obesity program earlier this year.

The company has begun enrolling about 400 obese, non-diabetic subjects for a 16-week Phase 2 dose-ranging study that will evaluate three doses ranging up to 360 micrograms with participants taking the drug either twice or three times a day. In addition to receiving either pramlintide or placebo, all participants will take part in a lifestyle intervention program.

Data from this study is expected to be available in the first half of 2006.ylin.co