CHICAGO — In a recent proof-of-concept study, a hydrogel capsule created from food-derived ingredients showed great weight loss than placebo, according to a presenter at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.
“Oral administration of Gelesis100, a novel biocompatible hydrogel, significantly decreases body weight in overweight and obese subjects, especially in prediabetic subjects, with an excellent safety profile,” Hassan M. Heshmati, MD, chief medical officer of Gelesis, which manufactures the product, said during a press conference.
Heshmati showed data from a randomized, double-blind, placebo-controlled study that observed 128 participants (68% female; mean age, 44.2±11.7 years) with obesity or overweight (mean BMI, 31.7±2.4 kg/m2) but without diabetes who were also on a hypocaloric diet.
The participants received either placebo (n=42) or one of two doses of Gelesis100 — 2.25 g (n=42) or 3.75 g (n=41) — and, at the end of the study of approximately 90 days, participants receiving Gelesis100 2.25 g had a greater change in body weight (–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; P=.026). In those participants with prediabetes (placebo, n=11; Gelesis100 2.25 g, n=9; Gelesis100 3.75 g, n=9), Heshmati showed a greater difference in body weight with the placebo group losing approximately 4% of body weight while those in the 2.25 g group lost approximately 11% (P=.019).
Additionally, 29% of 2.25 g users converted to normal weight from overweight, as compared to 0% on placebo and 8% on the higher dose, while 78% of those with prediabetes on the higher dose returned to normoglycemia, as compared to 56% on the lower dose and 27% on placebo.
Heshmati said the medication was well tolerated with generally mild gastrointestinal complaints that were less prominent with the lower dose.
For More Information: Heshmati H. Abstract SUN-0897. Presented at: The joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-24, 2014; Chicago.
Disclosures: Heshmati is an employee of Gelesis.