(HealthDay News) — Beloranib appears to be effective and safe for weight loss in patients with obesity, according to a phase 2 study published in Diabetes, Obesity and Metabolism.
Dennis D. Kim, MBA, from Zafgen Inc. in Cambridge, Massachusetts, and colleagues examined the efficacy, safety and tolerability of beloranib for treatment of obesity. One hundred forty-seven participants were randomly assigned to beloranib suspension (0.6 mg, 1.2 mg and 2.4 mg) or placebo, administrated subcutaneously for 12 weeks.
No diet or exercise advice was given to the participants.
Beloranib resulted in dose-dependent progressive weight loss of −5.5 kg for 0.6 mg, −6.9 kg for 1.2 mg and −10.9 kg for 2.4 mg doses, compared with −0.4 kg with placebo (all P<.0001 vs. placebo), the researchers found.
However, compared with placebo, beloranib treatment was associated with more frequent sleep disturbance and gastrointestinal adverse events, although these were generally mild to moderate, transient and dose-related, according to the researchers. As a result, there were more early study withdrawals in participants in the highest-dose beloranib group.
“In this 12-week phase 2 study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors,” the researchers wrote. “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.