Data from a 16-week Phase II study showed that Pramlintide reduces body weight in obese subjects.

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

The study showed statistically significant, progressive weight loss of 3.6 percent ( 3.5 kilograms ) compared to placebo, 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.

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.

Pramlintide was generally 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, Rockefeller University and investigator, Howard Hughes Medical Institute.

Symlin ( Pramlintide ) injection was approved by the U.S. Food and Drug Administration ( FDA ) on March 16, 2005.
Symlin is given at mealtime and is indicated for:

- Type 2 diabetes, as an adjunct treatment in patients who use mealtime Insulin therapy and have failed to achieve desired glucose control despite optimal Insulin therapy, with or without a concurrent sulfonylurea agent and/or Metformin;
- Type 1 diabetes, as an adjunct treatment in patients who use mealtime Insulin therapy and who have failed to achieve desired glucose control despite optimal Insulin therapy.


Source: European Congress on Obesity ( ECO ), 2005


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