-- The GLOW (Gelesis Loss Of Weight) study is a six-month, randomized, double-blind, placebo-controlled, parallel-group study designed to further assess the effect of Gelesis100 on body weight and glycemic control parameters in overweight and obese subjects, including pre-diabetics and type 2 diabetics
BOSTON, Jan. 9, 2015 /PRNewswire/ -- Gelesis, a biotechnology company focused on the development of first-in-class therapeutics to induce weight loss and improve glycemic control, announced today that it has initiated the GLOW study.
The GLOW 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, including prediabetics and type 2 diabetics. The study will be conducted in ten sites in Europe and the United States. The primary endpoints for the GLOW study are change in total body weight from baseline to end of randomized treatment and percent of patients with at least five percent weight loss. The secondary endpoints include changes in key glycemic control parameters.
"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."
Obesity, a serious medical condition that is rapidly growing in prevalence worldwide, is a major risk factor for developing pre-diabetes and type 2 diabetes. According to a 2012 Centers for Disease Control (CDC) report, approximately 79 million Americans were obese, and as many as 77 million Americans were considered overweight, with many expected to cross the threshold into obesity in the near future.
About Prediabetes and Type 2 Diabetes
Type 2 diabetes is marked by abnormal blood glucose levels which, if left untreated, can lead to serious complications including death. The American Diabetes Association cited type 2 diabetes as the seventh leading cause of death by disease in the United States in 2010. In 2012, approximately 26 million Americans suffered from type 2 diabetes, and more than 85% of those Americans were overweight or obese. An additional 86 million American adults over the age of 20 years were considered prediabetic (defined by a fasting blood glucose level >/= 100 mg/dL and < 126 mg/dL), with approximately 1.7 million new diagnoses of type 2 diabetes a year.
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 U.S. Food and Drug Administration (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 glycemic control mechanisms. 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 two millimeters 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.
Gelesis is a clinical stage company focused on the development of novel therapies to induce weight loss and improve glycemic control in overweight and obese patients. The Gelesis executive and advisory team includes some of the world's leading experts in obesity research and clinical development, entrepreneurs, and innovators in advanced materials. Gelesis was co-founded by PureTech, a science and technology R&D company.