Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis” or the “Company”) the maker of Plenity for weight management, today released a poster presentation at the International Congress of Endocrinology in Singapore. The LIGHT-UP study evaluated the safety and efficacy of GS200, an investigational oral hydrogel, which was designed to emulate the properties of ingested raw vegetables, with slightly different mechanical properties compared to Plenity (GS100).
The LIGHT-UP study was conducted over 25 weeks in 254 participants with prediabetes or type 2 diabetes and a BMI of 27-40 kg/m2. It met its primary endpoints and GS200 reported a highly favorable categorial weight loss response and tolerability in a population that often struggles to lose weight and is at high risk for obesity-related complications. One out of three GS200-treated adults were “super responders,” losing at least 10% of their body weight and on average losing 13% (~30 pounds), or 7 inches off their waist circumference in only 25 weeks.
“In previous studies we observed better weight loss response for individuals with pre-diabetes. In this study we wanted to understand if we could replicate this intriguing finding also with people who have type 2 diabetes, since typically weight loss is even more challenging for them” said Frank L. Greenway, MD, Medical Director and Professor at the Pennington Biomedical Research Center, Louisiana State University and one of the study’s lead investigators. “These findings could help us to understand the reason why the hydrogel therapy works better for people with elevated insulin resistance, which is important given the heterogeneity of the mechanisms driving weight gain and obesity.”
The study also investigated meal-time insulin release in people with prediabetes using a two-hour oral glucose tolerance test. Participants with pre-diabetes treated with GS200 had significantly less total mealtime insulin release, compared to placebo, the mean difference was -22.0%, P=0.04. The peak level of mealtime insulin was also significantly lower for people that used GS200 when compared to placebo with a mean difference of 47.3μU/mL, P=0.03.
“These reductions in mealtime insulin release were statistically significant even after controlling for changes in weight loss between GS200 and placebo, indicating that the observed improvements are independent of weight loss, suggesting additional mechanisms involved in the metabolic effects of the oral hydrogel technology,” said Elaine Chiquette, Gelesis Chief Scientific Officer. “These are exciting results, and we continue to investigate how GS200 affects insulin response and weight loss in people with prediabetes and type 2 diabetes.”