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Zafgen Announces New Weight Loss and Safety Data from Phase 2 Study of Beloranib in Obesity at Obesity Week 2013
Date:11/15/2013

were allowed to eat normally and were not counseled to change their diet or exercise habits.

Results from this study showed that after 12 weeks of treatment, subjects on 0.6 mg, 1.2 mg, or 2.4 mg of beloranib lost on average (+/- standard error of mean) -5.5 +/- 0.5 kg, -6.9 +/- 0.6 kg, and -10.9 +/- 1.1 kg, respectively vs. -0.4 +/- 0.4 kg for those on placebo (all p<0.0001 vs. placebo).  The study also showed that weight loss with beloranib was progressive and continuing at week 12, reduced sense of hunger, improved cardiometabolic risk markers, and was generally well-tolerated.  In addition to confirming the findings from previous studies that showed improvements in LDL-cholesterol, HDL-cholesterol and triglycerides, this study also demonstrated beloranib's effects to lower blood pressure.  Using 24-hour Ambulatory Blood Pressure Monitoring, clinically and statistically significant improvements in systolic blood pressure were observed for the 1.2 mg and 2.4 mg doses, showing reductions of 7.6 mmHg and 12.0 mmHg, respectively.

There were no serious adverse events (AEs) deemed to be related to the study drug and no clinically significant abnormal laboratory measures, vital signs, or electrocardiography (ECG) findings.  The most common adverse events with a higher incidence rate in those taking beloranib vs. placebo were nausea, diarrhea, headache, injection site bruising, and insomnia.  These adverse events were generally mild, transient and self-limiting in nature.

"These full Phase 2 results are an exciting prospect for the treatment of severely obese patients," said Louis Aronne, M.D., Clinical Professor of Medicine at Weill Cornell Medical College.1 "Beloranib continues to demonstrate a unique ability to deliver rapid and significant weight loss as well as meaningful improvements in key cardiometabolic risk markers.  Based on this supporting data, beloranib has the
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SOURCE Zafgen, Inc.
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