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GLOW Gelesis100 study

Gelesis initiates six-month GLOW Gelesis100 study

The study will assess the effect of repeated administration of Gelesis100 over six months on body weight and glycemic control parameters in 168 overweight and obese patients

Gelesis has initiated the Gelesis Loss Of Weight (GLOW) study, a six-month, randomised, double-blind, placebo-controlled, parallel-group study designed to further assess the effect of Gelesis100 on body weight and glycaemic control parameters in overweight and obese subjects, including pre-diabetics and type 2 diabetics. The study will assess the effect of repeated administration of Gelesis100 over six months on body weight and glycemic control parameters in 168 overweight and obese patients.

The study will be conducted in ten sites in Europe and the US. The primary endpoints for the GLOW study are change in total body weight from baseline to end of randomised treatment and percent of patients with at least five percent weight loss. The secondary endpoints include changes in key glycaemic control parameters.

Gelesis100 is a non-systemic, orally administered capsule designed to induce weight loss. Each capsule contains thousands of proprietary, biocompatible hydrogel particles synthesized with starting materials that are Generally Recognized as Safe (GRAS) by the FDA. Gelesis100 capsules are taken prior to a meal with water, after which the small particles within the capsules hydrate and expand in the stomach and small intestine, triggering several important satiety and glycaemic control mechanisms. 

Gelesis Investigators Meeting for the GLOW study

Gelesis100 has several built in safety features: a) the volume it creates is limited by the amount of water consumed, b) the hydrated particles, which are 2mm in size, do not cluster or stick together and have similar elasticity (rigidity) as ingested food, and c) the particles partially degrade in the colon, releasing absorbed water.

The particles absorb the water and swell to 100 times their original size in the stomach, mixing with food to create greater volume. After the particles travel through the small intestine, enzymes in the large intestine degrade them, and they release the water and are excreted.

“We designed the GLOW study to assess the safety and efficacy of Gelesis100 over a longer period of time on a broader patient population, including type 2 diabetics, as compared to the First Loss Of Weight (FLOW) study,” said Hassan Heshmati, CMO of Gelesis. “We are eager to further build upon the FLOW study, which resulted in statistically significant weight loss over three months in overweight and obese patients.”

Please click here to read more about the FLOW study.

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