Beloranib Safe Efficacious for Weight Loss in Obesity
Tolerable at doses of 0.6 and 1.2 mg; more adverse events with dose of 2.4 mg
FRIDAY, May 22, 2015 (HealthDay News) -- Beloranib seems efficacious and safe for weight loss in obese patients, according to a study published in the June issue of Diabetes, Obesity and Metabolism.
Dennis D. Kim, M.B.A., from Zafgen Inc. in Cambridge, Mass., and colleagues examined the efficacy, safety, and tolerability of beloranib treatment for obesity. One hundred forty-seven participants were randomized to beloranib suspension (0.6, 1.2, and 2.4 mg) or placebo, administrated subcutaneously for 12 weeks. No diet or exercise advice was given to the participants.
The researchers found that beloranib resulted in dose-dependent progressive weight loss of −5.5 ± 0.5 kg for 0.6 mg, −6.9 ± 0.6 kg for 1.2 mg, and −10.9 ± 1.1 kg for 2.4 mg doses, compared with −0.4 ± 0.4 kg with placebo (all P < 0.0001 versus placebo). Beloranib-linked weight loss correlated with decreases in waist circumference and body fat mass, and with improvements in lipids, high-sensitivity C-reactive protein, and blood pressure. Compared with placebo, beloranib treatment was associated with more frequent sleep disturbance and gastrointestinal adverse events; these were generally mild to moderate, transient, and dose-related. As a result, there were more early study withdrawals in participants in the highest-dose beloranib group.
"In this 12-week phase II study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors," the authors write. "These findings represent a novel mechanism for producing clinically meaningful weight loss."
Several authors disclosed employment or other financial ties to Zafgen, the developer of beloranib.