Gelesis100 is indicated to aid in weight management in overweight and obese adults with a body mass index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise.
The Gelesis Loss Of Weight (GLOW; NCT02307279) study assessed the effects of Gelesis100 in subjects with a BMI of 27-40 kg/m2. Four hundred thirty-six subjects were randomized to 2.25 g of Gelesis100 or placebo in capsules taken with 500 mL (16 oz) of water before lunch and dinner while on a hypocaloric diet (-300 kcal/day) for 24 weeks. This subanalysis assessed subjects who reached a BMI below 27 kg/m2 during the course of the study.
Of the 223 subjects randomized to Gelesis100, 22 subjects (55% females, 46% overweight, 36% prediabetics, 18% type 2 diabetics) reached a BMI below 27 kg/m2 after a mean treatment period of 106 days. These subjects continued to be exposed to Gelesis100 for an additional mean period of 61 days. The rate of weight loss tapered after reaching the BMI threshold of 27 kg/m2. The weight loss was 11.1% before versus 3.3% after reaching this threshold. In subjects reaching a BMI < 27 kg/m2, there was no increased safety risk compared to Gelesis100-treated subjects who never reached that threshold or compared to placebo-treated subjects who reached a BMI < 27 kg/m2. No serious adverse events were observed with Gelesis100.
Gelesis100 demonstrated favorable safety and tolerability profile when administered in overweight subjects with a BMI < 27 kg/m2 while maintaining the weight loss benefit.