Amylin says diabetes drug helps obese shed weight
Amylin Pharmaceuticals Inc. said on Friday that a high dose of its diabetes drug Symlin, given three times a day by injection, helped obese patients shed weight in a mid-stage clinical trial.
A phase II trial of 204 obese subjects found they lost 3.6 percent of their weight after 16 weeks of treatment, the company said.
The results, to be presented at medical meetings in Athens, Greece and San Diego, also showed that the weight loss was progressive and did not show signs of a plateau, said Dan Bradbury, chief operating officer, at San Diego-based Amylin.
Trial participants were told to continue their usual diet and exercise habits.
Bradbury said the results were most pronounced in people with a body mass index of 30 to 35—the lower end of the study’s range of 30 to 45. This group—31 percent of the study participants—lost 5 percent of their weight.
Symlin was approved in March by the U.S. Food and Drug Administration for use with insulin in patients with both type 1, or juvenile, and type 2 diabetes. The drug is a synthetic version of the hormone amylin, another substance that is reduced in diabetics and used by the body to help control blood sugar levels.
Symlin carries a boxed warning about the risks of severe hypoglycemia, a dangerous drop in blood sugar, when used in combination with insulin, but that warning would not apply to non-diabetics, Bradbury said.
The drug’s most common side effect is nausea.
By the end of the obesity trial, most patients were getting 240 micrograms of Symlin three times daily, compared with the 120 micrograms people with type 2 diabetes typically receive before meals, he said.
Amylin is conducting another phase II trial which will test a dose of up to 360 mcg in 400 people. In this trial, participants will also be encouraged to diet and exercise.
Bradbury said “our rationale is that, even with injectable products, there is a huge unmet need for obesity treatments.”
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