According to a new proof-of-concept study, 2 doses a day of a novel, biocompatible hydrogel, which is not systematically absorbed, significantly decreased body weight in overweight and obese patients….
The product known as Gelesis100 (Gelesis) contained thousands of tiny hydrogel particles that were administered in capsules that dissolved and expanded in the stomach, and would mix with ingested food, which created a larger volume and led to a feeling of fullness, but later was eliminated. These capsules are taken prior to a meal, and after a patient swallows the capsule it is washed down by water, which the particles inside the capsule then absorb, thus led to the expansion in volume, which is covered by the amount of liquid in the stomach or small intestine.
The randomized double-blinded study consisted of 128 non-diabetic overweight and obese patients at five sites in Denmark, Italy, and the Czech Republic. Two doses of Gelesis100 and a placebo were used in the new study. Hassan Meshmati, MD, chief medical officer for Gelesis and a study co-investigator, explained, "The low dose is really the best dose in terms of efficacy and safety." Dr. Meshmati presented the findings of this study in a poster and during a press conference at ICE/ENDO 2014. The participants of the study were randomized into three categories — 43 received 2.25 grams of Gelesis100 twice a day with water before a meal, 42 received 3.75 grams of Gelesis100 under the same conditions, and 43 received a placebo capsule containing cellulose. All participants were instructed to eat 600 calories less per day.
After twelve weeks of treatment, approximately 6% of body weight was lost in the group that received low-dose of the drug, and weight-loss plateaus weren’t experienced. However, the group that received the higher dose lost only 4.5% of body weight, and 4.1% for those on the placebo. The higher dose appeared to precipitate flatulence, abdominal pain, and diarrhea, and these side effects were seen less often with the group that received the lower dose, which Dr. Meshmati believed was a more tolerable dose. He hypothesized the group that received the higher dose lost less weight possibly due to drug tolerability issues, which he believed lead to lower compliance. Additionally, a dramatic weight loss around an average of 10.9% of body weight reduction was seen in individuals with pre-diabetes, which led investigators to speculate that the drug might reduce absorption of glucose.
- After twelve weeks of treatment, approximately 6% of body weight was lost in the group that received low-dose of the drug, and weight-loss plateaus weren’t experienced
- The higher dose appeared to precipitate flatulence, abdominal pain, and diarrhea, and these side effects were seen less often with the group that received the lower dose, which Dr. Meshmati believed was a more tolerable dose.
Joint Meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014; June 23, 2014. Abstract SUN-0897
Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. News and information for Medical Professionals.