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ARTICLE | Clinical News

Subcutaneous beloranib: Phase IIb data

February 22, 2016 8:00 AM UTC

Data from 66 evaluable Type II diabetics with severe obesity in the double-blind, Australian Phase IIb ZAF-203 trial showed that twice-weekly 1.2 and 1.8 mg subcutaneous beloranib for 6 months each met the primary endpoint of reducing body weight vs. placebo (reductions of 13.5% and 12.7%, respectively, vs. a reduction of 3.1%, p<0.0001 for both). Additionally, 92% and 95% of patients receiving low- and high-dose beloranib, respectively, achieved a 5% reduction in body weight vs. 27% of patients receiving placebo (p<0.0001 for both). Furthermore, 64% and 74% of patients receiving low- and high-dose beloranib, respectively, achieved a 10% reduction in body weight vs. 5% of patients receiving placebo (p<0.0001 for both).

Both low- and high-dose beloranib also met the secondary endpoint of a greater absolute reduction in HbA1c from baseline to week 26 vs. placebo (reductions of 2% for both vs. a reduction of 0.6%, p<0.0001 for both). Additionally, 72% and 74% of patients receiving low- and high-dose beloranib, respectively, achieved an HbA1c of <7% at 6 months vs. 23% of patients receiving placebo (p<0.0.01 for both). Furthermore, 68% and 63% of patients receiving low- and high-dose beloranib, respectively, achieved an HbA1c of <=6.5% at 6 months vs. 18% of patients receiving placebo (p<0.01 for both). The most common adverse events reported were upper respiratory tract infection, diarrhea and injection-site bruising. Ten patients receiving beloranib withdrew due to adverse events vs. 2 patients in the placebo arm. There were 7 serious adverse events in patients receiving beloranib vs. 2 in patients receiving placebo. One of the serious adverse events was a pulmonary embolism in a patient receiving low-dose beloranib. Patients in the trial also followed a diet and exercise regimen. ...