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Gelesis100 trial

Gelesis enrols first US patient in GLOW Gelesis100 trial

Company granted US composition of matter patent for Gelesis’ technology

Gelesis has announced the first patient enrolled from the United States in its pivotal GLOW (Gelesis Loss Of Weight) study. GLOW will assess the long-term safety and efficacy of Gelesis100, a novel oral capsulated device designed to achieve weight loss in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes. GLOW was initiated in November 2014 and has been ongoing at nine clinical trial sites across four European countries, where 125 patients have completed treatment.

The Gelesis100 capsule contains small hydrogel particles that, when taken with water ahead of a meal, is designed to employ multiple mechanisms of action along the gastrointestinal (GI) tract to induce weight loss and improve glycaemic control. In a three-month proof-of-concept study, Gelesis100 demonstrated statistically significant weight loss and improvement of glycaemic control in adults who are overweight or have obesity, especially in those with prediabetes.

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.

GLOW will study the impact of Gelesis100 in achieving weight loss and glycaemic control over a six-month time period and in a broader patient population, including those who have type 2 diabetes, across 32 sites in the US, Canada and Europe.

GLOW is a randomised, double-blind, placebo-controlled, parallel-group study of 460 adults who are overweight or have obesity (BMI 27-40) between the ages of 22 to 65 years, including those with prediabetes and type 2 diabetes. The study’s primary endpoints are placebo-adjusted change in total body weight from baseline to end of treatment, and percent of individuals with at least five percent weight loss. The secondary endpoints include changes in key glycaemic control parameters.

“There is a great need for new, safe therapeutic options that facilitate both weight loss and glycemic control, especially in people with prediabetes," said Gelesis Scientific Advisory Board member, Dr Caroline Apovian, Professor of Medicine and Pediatrics at Boston University School of Medicine. “We are excited to study the Gelesis product in the U.S. with some of the top clinicians in this field.”

Gelesis received positive confirmation from the FDA in July 2015 that GLOW received a Non-Significant Risk (NSR) medical device study designation, which allowed the company to expand the study to the US. The FDA's NSR designation applies to devices that are generally considered to be low risk based on their intended use in the study. Examples of NSR devices include daily wear contact lenses, dental filling materials and jaundice monitors for infants.

“Enrolling our first patient in the US is an important milestone as we advance this novel therapeutic as a potentially effective, non-invasive weight-loss treatment for adults who are overweight or have obesity,” said Dr Hassan Heshmati, Chief Medical Officer of Gelesis. “More than two-thirds of US adults are overweight or obese, so there is a critical need for new approaches that can help these individuals achieve and maintain a healthy weight.”

The company also announced the allowance of a composition of matter patent from the US Patent and Trademark Office (USPTO) for Gelesis’ technology through 2032.

Gelesis already owns two additional patent families with granted or allowed patents in the US, Europe, Canada, Australia, Japan, Russia, Mexico, China and Hong Kong. 

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