Amylin's pramlintide produces more weight loss than diet and exercise alone, study says

By Angela McDaniels

Seattle, Feb. 9 - Amylin Pharmaceuticals Inc. said that obese participants who received the company's pramlintide lost more weight than those who received a placebo during a 16-week, randomized, double-blind, dose-ranging phase 2 study.

Average weight loss across the pramlintide treatment groups ranged from 8.4 to 13.4 pounds, compared with 6.2 pounds for the placebo group.

Both twice-daily and three-times-a-day regimens demonstrated clear efficacy, the company said, and weight loss experienced with pramlintide was progressive through 16 weeks.

Pramlintide was well tolerated and no new safety signals were observed in this study, which included higher doses than those previously studied.

Consistent with the company's previous observations, the most common adverse event with pramlintide was mild nausea. Weight loss for subjects experiencing nausea was similar to that for subjects not experiencing nausea.

The trial included 408 obese subjects with an average body mass index of 38 kg per m2. All study volunteers participated in a structured lifestyle intervention program that included diet, exercise and behavioral counseling.

After a one-week placebo lead-in period, subjects were randomized to 16 weeks of treatment with either a placebo or pramlintide at one of 6 dosage regimens (120, 240, or 360 micrograms, given either two or three times a day before meals).

"Peptide therapeutics affecting satiety and metabolism represent an innovative, promising approach to obesity drug development," Eric Ravussin of Pennington Biomedical Research Center in Baton Rouge, La., and a member of Amylin's scientific advisory board, said in a company news release.

"The finding that pramlintide given two or three times daily can elicit progressive weight loss beyond that achieved with a comprehensive lifestyle intervention program adds to the existing efficacy and safety information with this compound."

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

Amylin is a biopharmaceutical company based in San Diego.

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