Background

The Gelesis Loss Of Weight (GLOW; NCT02307279), a pivotal weight-loss study, demonstrated that Gelesis100 offers an important new approach in the management of overweight and obesity given its safety and efficacy profile.

Methods

The GLOW study assessed the effects of Gelesis100 in subjects with a body mass index (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 with a BMI below 35 kg/m2. Co-primary efficacy endpoints were body weight (BW) and BW responders at 5% (≥ 5% BW loss). Additional efficacy endpoints included BW responders at 10%, estimated excess BW (EEBW), and waist circumference (WC). Data were analyzed using analysis of covariance and Logit models with multiple imputation.

Results

The subanalysis included 284 subjects (56% females, mean age 48.4 years, mean BMI 31.9 kg/m2, 25% prediabetics, 10% type 2 diabetics). Mean +/- SD BW losses were 6.7 +/- 6.1% vs 4.5 +/- 5.3% (P < 0.005), for Gelesis100 vs placebo, respectively. BW responders at 5% were 59% vs 45% (P < 0.05), and at 10% were 28% vs 13% (P < 0.01), for Gelesis100 vs placebo, respectively. In the Gelesis100 arm, decreases in EEBW and WC were 34 +/- 33% and 7.0 +/- 5.6 cm, respectively (statistically significant vs placebo). In the Gelesis100 arm, other than a 14% increase of the incidence of the overall gastrointestinal adverse events (AEs) and an 8% increase of the incidence of abdominal distension, the majority being of mild intensity, there were no differences in the incidence and severity of AEs with the placebo arm. No serious AEs were observed with Gelesis100.

Conclusions

Gelesis100 profile could allow shifting the focus of weight-loss therapy to subjects with lower BMI.