Medical News Today recently reported on research investigating the relationship between depression and diabetes, presented at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago, IL. Now, from the same conference, we bring news of a "smart pill" called Gelesis100, which is reported to be a safe and effective weight loss aid.
Reportedly in development for 15 years, Attiva represented a new way of thinking about weight loss treatment.
The capsule contains a "hydrogel," comprised of two food ingredients that have a unique interaction when cross-linked.
Although the hydrogel is only about the size of a sugar grain, when consumed with water, the grain expands into gel-form in the stomach, stretching the stomach walls. The stomach's nerve fibers are then stimulated, telling the brain that the stomach is full and unable to receive any more food.
Attiva was found to be safe and well-tolerated, with relatively minor side effects. About 7% of participants reported nausea, 4% reported constipation or stomach ache and one person reported having diarrhea.
The next step for manufacturer Gelesis was to demonstrate to the Food and Drug Administration (FDA) that the smart pill can help people lose weight over a year-long period, in accordance with the guidelines for obesity drugs. But little further has been heard of Attiva, until now.
Attiva, rebranded as 'Gelesis100,' passes 'proof of concept' randomized controlled trial
At ICE/ENDO 2014, Gelesis revealed results of a new "proof of concept" trial on the smart pill, now rebranded as Gelesis100.
The participants who lost the most weight during the study were prediabetic subjects. They lost an average of 10.9% of their body weight.
A group of 43 people were randomly assigned to receive 2.25 g of Gelesis100 before lunch and dinner, a group of 42 people received 3.75 g of Gelesis100 and a control group of 43 participants received a placebo containing cellulose, a bulking agent. All participants were instructed to eat 600 fewer calories a day.
Participants were weighed at the start and end of the 12-week study. The people in the 2.25 g group had lost 6.1% of their body weight after treatment, the 3.75 g group lost 4.5%, and the placebo group lost 4.1%.
The study investigators believe that the higher dose group lost less weight because of "lower tolerability" to the hydrogel.
In the 2.25 g group, subjects with initial high fasting blood sugar (greater than the median level of 93 mg/dL) lost more weight than other participants in that group, with an 8.2% average body weight reduction.
The participants who lost the most weight in the study, however, were prediabetic subjects - with a fasting blood sugar level of 100-125.6 mg/dL - who lost an average of 10.9% of their body weight.
Again, the trial found only minor side effects to be associated with the hydrogel - bloating, flatulence, abdominal pain and diarrhea, which reportedly occurred less in the smaller dose group.
Dr. Hassan Heshmati, chief medical officer for Gelesis and a study co-investigator, says:
"Given the excellent safety profile observed in the study, Gelesis100 has the potential to fulfill the unmet need for a safe and effective weight loss agent. This is particularly impactful for individuals with mildly elevated blood sugar (prediabetic subjects), for whom weight loss is particularly important because they are at increased risk for diabetes."
The manufacturer also confirmed that if Gelesis100 is approved by the FDA then it will be regulated as a medical device.
In 2013, Medical News Today reported on a controversy surrounding American-made obesity drugs being rejected by European regulators.