{"id":47655,"date":"2022-08-25T13:02:22","date_gmt":"2022-08-25T11:02:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/clinical-data-from-the-light-up-study-presented-at-the-international-congress-of-endocrinology-suggests-new-gelesis-oral-hydrogel-may-improve-insulin-sensitivity-and-favorably-impact-metabolic-syndrom\/"},"modified":"2022-08-25T13:02:22","modified_gmt":"2022-08-25T11:02:22","slug":"clinical-data-from-the-light-up-study-presented-at-the-international-congress-of-endocrinology-suggests-new-gelesis-oral-hydrogel-may-improve-insulin-sensitivity-and-favorably-impact-metabolic-syndrom","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/clinical-data-from-the-light-up-study-presented-at-the-international-congress-of-endocrinology-suggests-new-gelesis-oral-hydrogel-may-improve-insulin-sensitivity-and-favorably-impact-metabolic-syndrom\/","title":{"rendered":"Clinical Data from the LIGHT-UP Study Presented at the International Congress of Endocrinology Suggests New Gelesis Oral Hydrogel May Improve Insulin Sensitivity and Favorably Impact Metabolic Syndrome"},"content":{"rendered":"
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\nThe 25-week weight loss study which achieved its previously reported primary endpoints also examined the effects of GS200 on insulin resistance<\/i>\n<\/p>\n

BOSTON–(BUSINESS WIRE)–Gelesis Holdings Inc. (NYSE: GLS) (\u201cGelesis\u201d or the \u201cCompany\u201d) 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).\n<\/p>\n

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\nThe 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 \u201csuper responders,\u201d 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.\n<\/p>\n

\n\u201cIn previous studies we observed better weight loss response for individuals with prediabetes. 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\u201d said Frank L. Greenway, MD, Medical Director and Professor at the Pennington Biomedical Research Center, Louisiana State University<\/a> and one of the study\u2019s lead investigators. \u201cThese 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.\u201d\n<\/p>\n

\nThe study also investigated meal-time insulin release in people with prediabetes using a two-hour oral glucose tolerance test. Participants with prediabetes 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 47.3\u03bcU\/mL, P=0.03.\n<\/p>\n

\n\u201cThese 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,\u201d said Elaine Chiquette, Gelesis Chief Scientific Officer. \u201cThese are exciting results, and we continue to investigate how GS200 affects insulin response and weight loss in people with prediabetes and type 2 diabetes.\u201d\n<\/p>\n

\nAbout Gelesis<\/b>\n<\/p>\n

\nGelesis Holdings Inc. (NYSE: GLS) (\u201cGelesis\u201d) is a consumer-centered biotherapeutics company and the maker of Plenity\u00ae<\/sup>, which is inspired by nature and FDA cleared to aid in weight management. Our first-of-their-kind non-systemic superabsorbent hydrogels are made entirely from naturally derived building blocks. They are inspired by the composition and mechanical properties of raw vegetables, taken by capsule, and act locally in the digestive system, so people feel satisfied with smaller portions. Our portfolio includes Plenity\u00ae<\/sup> and potential therapies in development for patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)\/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation. For more information, visit gelesis.com<\/a>, or connect with us on Twitter @GelesisInc. Plenity\u00ae<\/sup> is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25\u201340 kg\/m\u00b2, when used in conjunction with diet and exercise.\n<\/p>\n

\nAbout Gelesis\u2019 LIGHT-UP Clinical Study<\/b>\n<\/p>\n

\nThe multicenter, double-blind, randomized, 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. The study met both of its primary endpoints: the proportion of participants who achieved at least 5% body weight loss and the change in body weight after six months of therapy.\n<\/p>\n

\nA highly binary effect was observed with the GS200 treatment group, with a clear separation between responders and non-responders as early as after 6 weeks of treatment. Among the adults who completed the study protocol requirements (PP population), 64% of GS200-treated adults were Responders vs. 41% in the placebo group (p=0.001). In the analysis which also included data from the participants who didn\u2019t fully complete the study (ITT-MI), 55% of GS200-treated adults were Responders vs. 34% in the placebo group (p=0.0004). 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.\n<\/p>\n

\nWith 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.\n<\/p>\n

\nGS200 demonstrated a highly favorable 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.\n<\/p>\n

\nImportant Safety Information about Plenity<\/b>\n<\/p>\n