Background

In the US, less than 2% of subjects with overweight or obesity receive anti-obesity therapy. While there are numerous reasons for this extreme degree of undertreatment, concerns about the safety of existing therapies clearly play a role. There is an urgent need for therapies that result in meaningful weight loss with no increased safety risk.

Methods

The Gelesis Loss Of Weight (GLOW; NCT02307279) study assessed the effects of Gelesis100 in subjects with a body mass index (BMI) of 27-40 kg/m2. 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 presentation provides a comprehensive analysis of the safety data of the GLOW study. The safety and tolerability were assessed by recording adverse events (AEs) and serious AEs (SAEs), and monitoring results from physical examination, vital signs, and fasting laboratory tests, including hematology, blood chemistry, and serum vitamins.

Results

The randomized population included 436 subjects (56% females, mean age 48.0 years, mean BMI 33.8 kg/m2, 30% prediabetics, 11% type 2 diabetics, 223 on Gelesis100). In the Gelesis100 arm, other than a 9% increase of the incidence of the overall gastrointestinal AEs (with a trend for more abdominal distension, diarrhea, infrequent bowel movements, and flatulence), the majority being of mild intensity, there were no differences in the incidence and severity of AEs between the 2 arms. No SAEs were observed with Gelesis100. No relevant differences in physical examination and vital signs findings were observed between the 2 arms. There were no differences in the changes in hematology, blood chemistry (including serum sodium, potassium, calcium, and magnesium), and serum vitamins (vitamins A, B1, B2, B6, B9, B12, D, and E) between the 2 arms.

Conclusions

Gelesis100 is a safe and well-tolerated therapy to aid in weight management of subjects with overweight or obesity.