Axokine, a modified ciliary neurotrophic factor, appears to promote weight loss in overweight and obese patients with type 2 diabetes, according to the findings of a 12-week randomized trial. It is more difficult to achieve weight loss in diabetics compared to nondiabetics,” said lead author Alan Glicklich, MD, from Regeneron Pharmaceuticals, Inc., in Tarrytown, New York. “Some of the drugs that diabetics take promote weight gain, and these patients may also have a more difficult time losing weight due to insulin resistance and other factors,” he told Medscape in a phone interview.
Dr. Glicklich and colleagues presented their findings in an oral presentation today at the North American Association for the Study of Obesity annual meeting in Ft. Lauderdale, Florida.
The researchers conducted a 24-center, placebo-controlled 12-week safety and efficacy study. A total of 160 patients were randomized in a 1:1:1 ratio to receive Axokine, 1.0 µg/kg/day, 0.5 mcg/kg/day, or placebo.
Mean baseline body weight of the patients was 106.0 kg. All patients were receiving medication for diabetes: metformin, 82% of patients; sulfonylureas, 67%; and thiazolidinediones, 26%. Patients receiving meglitinides or insulin were excluded from the study.
A total of 157 patients were included in the modified intention-to-treat analysis, and 142 patients completed the study.
Compared with the placebo group, mean change from baseline in body weight at week 12 was significant for the 1.0-µg/kg/day group in patients receiving metformin (weight loss of 3.17 kg vs. 1.14 kg; P = .004), thiazolidinediones (3.34 kg vs. 0.24 kg; P = .021), and/or sulfonylureas (3.24 kg vs. 0.87 kg; P = .001).
In contrast, for the group taking 0.5-µg/kg/day, weight loss was not significant compared with placebo: patients receiving metformin lost 2.69 kg (P = .060); thiazolidinediones, 2.47 kg (P = .124); and sulfonylureas, 2.04 kg (P = .160).
“These data demonstrate that treatment with Axokine promoted statistically significant weight loss versus placebo in overweight and obese patients treated with a variety of classes of oral anti-diabetes medications,” the authors conclude in their abstract.
According to Dr. Glicklich, while the study did not compare diabetic patients with nondiabetics, the magnitude of weight loss at 12 weeks was similar to that seen in other studies with nondiabetics.
“Axokine appears to act in the brain, specifically in the hypothalamus — the part of the brain that regulates appetite,” Dr. Glicklich said. “We believe, from preclinical data, that it operates through a pathway similar to that of leptin,” he added.
The study was funded by Regeneron Pharmaceuticals, Inc., the manufacturer of Axokine. The drug is currently in phase III clinical trials, according to a company press release.
NAASO 2003 Annual Meeting: Abstract 100-OR. Presented Oct. 13, 2003.