Outcomes from the LIGHT-UP study that evaluated the safety and efficacy of GS200, an investigational oral hydrogel, has concluded the hydrogel may improve insulin sensitivity and positively impact metabolic syndrome. The findings were presented at the International Congress of Endocrinology in Singapore.
The multicentre, double-blind, randomised, placebo-controlled study enrolled 254 subjects and was designed to assess the change in body weight in adults with overweight or obesity, who have prediabetes or diabetes, after 25 weeks of treatment with a new oral superabsorbent hydrogel (GS200) or placebo.
It met its primary endpoints and GS200 reported a highly favourable 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% (~30lbs), or seven inches off their waist circumference in only 25 weeks.
The average body weight loss of the Responders was 11% (approximately 23 pounds) and their waist circumference was reduced by 5.5 inches on average. Importantly, Gelesis treated individuals had 2.8 higher odds compared with placebo to become Responders (adjusted odds ratio = 2.83, p=0.0004), achieving the first primary endpoint of the study.
With respect to average total weight loss, the complete GS200 treatment group (including both Responders and Non-Responders) demonstrated superiority over placebo after 25 weeks of treatment (body weight loss of 7.1% vs. 4.6%, P=0.0029 in the PP population or 6.9% vs. 4.3%, p=0.0011 in the ITT population), thereby achieving the second primary endpoint.
GS200 also demonstrated a highly favourable safety and tolerability profile as the overall incidence of adverse events (AEs) in adults treated with GSP200 was similar to the incidence of AEs in the placebo group.
“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 Dr Frank L Greenway, 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.”