Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction. LIPO-102 was well-tolerated when administered weekly for 8 weeks into the subcutaneous abdominal fat of healthy subjects. LIPO-102 injections in the anterior abdomen produced dose- and time-related reductions in mean abdominal circumference and volume of -1.2 cm (versus -0.1 cm for placebo;>
"Meaningful clinical changes in abdominal circumference have now been observed with LIPO-102 in 3 consecutive studies, including the most recent randomized, placebo-controlled, double-blind study," said John Dobak, M.D., Chief Executive Officer of Lithera. "The data from these clinical trials have helped us optimize dose parameters for the treatment of abdominal adiposity and symptomatic exophthalmos."
Sixty healthy adult, male and female subjects aged 18-65 with a body mass index (BMI) greater than or equal to 18.5 kg/m2 and <28 kg/m2 were enrolled in this double-blind, placebo-controlled study. Subjects were randomized to receive injections of placebo or one of two different doses of LIPO-102 into their anterior abdomen once weekly for 8 weeks. Safety and efficacy were evaluated weekly for 8 weeks and at 1, 6 and 12 weeks post-treatment. Abdominal circumference and volume were measured as a change from baseline using a 3-D photographic imaging system.
LIPO-102 was well-tolerated when administered into subcutaneous abdominal fat; there were no systemic effects of note, and locally there was no inflammation, nodularity or skin atrophy observed on physical examination of the injected sites. LIPO-102 was associated with reductions in abdominal circumference and volume when administered once weekly for 8 weeks with positive results seen in some individuals after 4 weeks of treatment and with the greatest changes observed at 1 and 6 weeks post-treatment.