Investigational obesity drug led to weight loss, improved CV risk
CHICAGO — Twelve-week data from an interim analysis of a phase 2 study of beloranib, a novel selective methionine aminopeptidase 2 inhibitor, demonstrate that treatment with the drug resulted in rapid, sustained body weight loss of up to about 10 kg, according to a company press release.
In addition to progressive weight loss, beloranib (Zafgen), which is indicated for the treatment of obesity, improved cardiovascular risk factors and was well-tolerated.
Researchers conducted a double blind, placebo-controlled study in obese men and women to determine beloranib’s safety, tolerability, pharmacokinetics and metabolic effects. Patients were randomly assigned to twice-weekly subcutaneous beloranib or placebo for 12 weeks; there were no diet restrictions and patients were not counseled on exercise habits.
Mean age among patients was 40.3 years; body weight was 101.2 kg and BMI was 37.9 kg/m2. Patients assigned to treatment in the full trial were randomly assigned to 0.6 mg (n=37), 1.2 mg (n=37) or 2.4 mg (n=36) subcutaneous beloranib or placebo (n=38). The current results reflect data for the first 19 patients who completed 12 weeks of treatment with 0.6 mg (n=5), 1.2 mg (n=6) or 2.4 mg (n=3) beloranib or placebo (n=5); these patients are part of a dose-selection cohort that preceded enrollment of the complete phase 2 trial, results of which are expected this summer.

Caroline Apovian
Beloranib was associated with improved weight loss after 12 weeks in all dosing groups: average –3.8 kg in the 0.6-mg group, –6.1 kg in the 1.2-mg group and –9.9 kg in the 2.4-mg group vs. +1.8 kg in the placebo group (P<.005 for all vs. placebo).
What’s more, beloranib improved cardiometabolic risk factors, including reduced triglycerides, LDL cholesterol and C-reactive protein vs. placebo. Treatment was also associated with a significant decrease in hunger.
Adverse events associated with treatment included nausea, vomiting and sleep disturbance, but overall the drug was well-tolerated.
“The need for new options for severely obese patients has never been greater,” Caroline Apovian, MD, FACN, professor of medicine and pediatrics in the section of endocrinology, diabetes and nutrition at Boston University School of Medicine, said in the release. “Beloranib is showing promise as a novel approach in this field, and the dramatic weight loss seen after only 12 weeks is very impressive. – by Stacey L. Adams
For more information:
Kim D. #188-LB. Presented at: ADA Scientific Sessions; June 21-25, 2013; Chicago.
Disclosure: The researchers report no relevant financial disclosures. Apovian serves on the clinical advisory board for Zafgen.