Amylin Pharmaceuticals’ lead diabetes drug, Symlin (pramlintide), helps obese people lose weight, according to Phase II study data from the company.
The 16-week study included 204 obese patients – 160 without diabetes and 44 with non-insulin-treated type 2 diabetes – who received either Symlin or placebo three times a day before meals. Participants were also asked to maintain their usual diet and exercise regimen. Results showed statistically significant, progressive weight loss of 3.6% (3.5kg) 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 recognised marker of abdominal obesity and cardiovascular risk. Subgroup analyses indicated that body weight reduction was most pronounced in subjects with obesity class I – defined as a body mass index of 30 to 35 – who lost around 5% of their body weight.
The company recently began enrolment into a further Phase 2 study in approximately 400 obese, non-diabetic subjects, which will evaluate three doses ranging up to 360mcg with twice and three times a day dosing regimens. Data are expected to be available in the first half of 2006.
Symlin is a synthetic analog of human amylin, a hormone known to play a role in the regulation of appetite and food intake. The product recently won the thumbs up from the US Food and Drug Administration for use together with insulin to treat both type 1 and type 2 diabetes patients who cannot adequately control their blood sugar level with insulin alone [[18/03/05c]].