Oral Administration of Gelesis100, a Novel Hydrogel, Significantly Decreases Body Weight in Overweight and Obese Subjects

Program: Abstracts - Orals, Poster Preview Presentations, and Posters
Session: SUN 0891-0905-Human Obesity: Targets and Therapies
Sunday, June 22, 2014: 1:00 PM-3:00 PM
Hall F (McCormick Place West Building)

Poster Board SUN-0897
Arne Astrup, MD1, Mette Kristensen, PhD1, Lucio Gnessi, MD, PhD2, Mikiko Watanabe, MD, PhD2, Stepan Svacina, MD3, Martin Matoulek, MD, PhD3, Pavol Hlubik, MD4, Hana Stritecka, PhD5, Franco Contaldo, MD, PhD6, Fabrizio Pasanisi, MD, PhD6, Hassan M Heshmati, MD7, Yishai Zohar7, Eyal S Ron, PhD7, Alessandro Sannino, PhD8, Christian Demitri, PhD8 and Cosimo Saponaro8
1University of Copenhagen, Frederiksberg C, Denmark, 2Policlinico Umberto I, Rome, Italy, 3General Hospital in Prague, Prague, Czech Republic, 4Nutrition Disorder Center, Hradec Kralove, Czech Republic, 5Faculty of Military Health Sciences, Hradec Kralove, Czech Republic, 6Federico II University Hospital, Naples, Italy, 7Gelesis, Boston, MA, 8Gelesis, Lecce, Italy
The effect on body weight of chronic oral administration of Gelesis100, a novel hydrogel, was assessed in 128 non-diabetic overweight and obese subjects randomized to two Gelesis100 arms (2.25 g twice daily, n = 43 and 3.75 g twice daily, n = 42) and a placebo arm (n = 43). Treatment was administered in capsules with 500 mL of water before lunch and dinner, in a double-blind, parallel-group fashion, over 12 weeks, in subjects on hypocaloric diet (-600 kcal/day). Statistical analysis used analysis of covariance model with baseline weight, gender, and body mass index (BMI) as covariates, comparing Gelesis100 arms to placebo arm. One hundred twenty-five subjects had at least one post-baseline body weight assessment (intention-to-treat “ITT” population). The ITT population included 40 males and 85 females, with a mean age ± standard deviation (SD) of 44 ± 12 years and a mean BMI ± SD of 31.7 ± 2.4. One hundred ten subjects completed the treatment. Dropout rates were 5%, 24%, and 21%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. One hundred twenty-six subjects provided safety data. In the ITT population, the mean ± SD body weight percent changes from baseline to the end of treatment were -6.1 ± 5.1%, -4.5 ± 4.5%, and -4.1 ± 4.4%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. Weight loss was statistically significant with Gelesis100 2.25 g (P = 0.026). Lower tolerability and compliance may explain the observed efficacy result with Gelesis100 3.75 g. The extent of weight loss was more pronounced in subjects on Gelesis100 2.25 g with high fasting glucose (> median, 5.15 mmol/L) at baseline (-8.2 ± 5.3%; P = 0.006), especially in those with impaired fasting glucose at baseline (-10.9 ± 4.3%; P = 0.019). There was a significant negative correlation between fasting glucose at baseline and change in body weight in Gelesis100 2.25 g arm (r = -0.50; P < 0.001) contrasting with a lack of correlation in placebo arm (r = -0.06; P = 0.708). The most common adverse events (AEs) were bloating, flatulence, abdominal pain, and diarrhea, with lower prevalence in Gelesis100 2.25 g arm compared to placebo and Gelesis100 3.75 g arms. Serious AEs were observed in 3 subjects on placebo (gallstone and abdominal pain). In conclusion, chronic administration of Gelesis100 (2.25 g twice daily) to overweight and obese subjects significantly decreases the body weight, especially in subjects with impaired fasting glucose at baseline. The treatment is safe and well tolerated. Gelesis100 can be considered as a promising new therapy for obesity and a tool for weight management. If confirmed in subsequent studies, Gelesis100 has also the potential to induce dramatic weight loss in overweight and obese subjects with type 2 diabetes.

Disclosure: AA: , Gelesis. HMH: Consultant, Gelesis. YZ: Founder, Gelesis. ESR: Management Position, Gelesis. AS: Researcher, Gelesis. CD: Researcher, Gelesis. CS: Management Position, Gelesis. Nothing to Disclose: MK, LG, MW, SS, MM, PH, HS, FC, FP

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