Gelesis, a biotechnology company, has enrolled the first patient from the US in its Gelesis Loss Of Weight (GLOW) study, which will evaluate the long-term safety and efficacy of Gelesis100.
Gelesis100 is a new oral capsule designed to achieve weight loss in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes.
Started in 2014, GLOW is currently being conducted at nine clinical trial sites across four European countries, where 125 patients have completed treatment.
GLOW is a randomised, double-blind, placebo-controlled, parallel-group study of 460 adults who are overweight or have obesity between the ages of 22 to 65 years, including those with pre-diabetes and type 2 diabetes.
Its primary endpoints are placebo-adjusted change in total body weight from baseline to end of treatment, and percent of individuals with at least 5% weight loss.
The study's secondary endpoints include changes in key glycemic control parametres.
Gelesis said that its Gelesis100 capsule includes 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 encourage weight loss and improve glycemic control.
In a three-month proof-of-concept study, Gelesis100 showed statistically significant weight loss and improvement of glycemic control in adults who are overweight or have obesity, especially in those with prediabetes.
GLOW will also study the impact of Gelesis100 in achieving weight loss and glycemic control over a period of six months and in a broader patient population, including those who have type 2 diabetes, across 32 sites in the US, Canada and Europe.
Last July, the US Food and Drug Administration (FDA) awarded a Non-Significant Risk (NSR) medical device study designation to Gelesis' GLOW study, allowing the company to expand the study to the US.
Gelesis chief medical officer Hassan Heshmati said: "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 US Patent and Trademark Office (USPTO) has recently granted a composition of matter patent to Gelesis' technology.
Gelesis currently owns two more patent families with granted or allowed patents in the US, Europe, Canada, Australia, Japan, Russia, Mexico, China and Hong Kong, with several other patent families are in different stages of prosecution.