LIPO-202: Phase IIb data
The double-blind, U.S. Phase IIb RESET trial in 514 non-obese, healthy subjects with abdominal bulging in the periumbilical area due to excess subcutaneous fat showed that once-weekly 0.4 ug subcutaneous LIPO-202 injected into the abdomen for 8 weeks significantly improved response rate defined as a composite of a 1-point improvement in P-GAPS score and a 2-point improvement in CPnS score from baseline to week 9 vs. placebo (p<0.05). Lithera said 0.4 ug LIPO-202 also led to a significant improvement compared to placebo when response was defined as the composite of a 2-point improvement in P-GAPS score and a 2-point improvement in CPnS score from baseline to week 9 vs. placebo (p<0.05). Additionally, low-dose LIPO-202 led to a mean improvement of 2 points on a 7-point satisfaction rating scale. Furthermore, low-dose LIPO-202 significantly reduced mean circumference at the umbilicus (1.6 vs. 0.65 cm, p=0.001) and mean abdominal volume in the treatment zone (192 vs. 68 cm 3, p=0.002) from baseline to week 9 vs. placebo. ...