Dr. Michael Schlitt, Neurosurgeon, Neurosurgery, Seattle

Weight Loss Pill

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I recently came across an article about a new pill, Gelesis100, which is apparently supposed to be both a safe and effective weight loss aid.  However, this isn’t a new treatment; the pill, by manufacturer Gelesis, was previously known as Attiva, and was piquing the media’s interest back in 2010 after passing a clinical trial of 95 people.  Reportedly in development for 15 years, Attiva was a new way of thinking about weight loss treatment.  The capsule contains a “hydrogel”, which is comprised of two food ingredients that have a unique reaction when cross-linked with each other.

Gelesis

Gelesis, the company who created Gelesis100.

While the hydrogel is only around the size of a sugar grain, when it’s consumed with water, it expands into gel-form in the stomach, which stretches the stomach walls.  The stomach’s nerve fibers are then stimulated, which tells the brain that the stomach is full and unable to receive more food.  Attiva was found to be safe and well-tolerated, and with few side effects, mostly focused around nausea, constipation or diarrhea.  After this pill was created, Gelesis neded to demonstrate to the FDA that their pill can help people lose weight over a year-long period.  However, after that, there wasn’t a whole lot heard about Attiva.

At ICE/ENDO 2014, Gelesis revealed their new “proof of concept” trial on Attiva, which they rebranded as Gelesis100.  A group of 43 people were randomly assigned to receive 2.25g of Gelesis100 before lunch and dinner, a group of 42 received 3.75g and a control group of 43 received a placebo that contained cellulose.  All participants were then 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 2.25g group had lost 6.1% of their body weight after treatment, the 3.75g group lost 4.5% and the placebo group lost 4.1%.  The researchers believe that the higher dose group lost less weight due to “lower tolerability” to the hydrogel.

In the 2.25g group, subjects with initial high-fasting blood sugar lost more weight than other participants in the group, with an average reduction in body weight of 8.2%.  However, the people who lost the most weight were prediabetic subjects, who lost on average 10.9% of their body weight.  Once again, the trial found only minor side effects from hydrogel, mostly bloating, flatulence, abdominal pain and diarrhea, which occurred significantly less in the smaller dose group.  If Gelesis100 is approved by the FDA, then Gelesis will be regulated as a medical device.

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