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Obesity Capsule From Gelesis, Made to Swell Up in the Stomach, Passes First Human Trial

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in volume when it comes into contact with water. So this “hydrogel” can be packed tight into a capsule that’s small enough for people to swallow. When you drink a water to down the capsule, it releases all those superabsorbent and expanding hydrogel particles in the stomach to at least partly fill you up so you have less room for food.

Once the hydrogel particles are released and filling up with liquid, they put pressure on the walls of the stomach, sending a signal to the brain that says the person is full, and it’s time to stop eating. The particles mix with the food, which keeps the food in the stomach longer. Eventually, stomach acids then shrink the particles during digestion, so they release the water, and they can travel with the food to the small intestine. The particle can re-swell to an extent at that part of the journey, and increase the viscosity in the small intestine so that sugars and fatty acids get absorbed more slowly there. The hydrogels then proceed to the large intestine, release their water, and disintegrate. The Gelesis product is designed so it never gets absorbed into the bloodstream like a drug. It gets excreted in the feces.

The technical challenges to navigate this biological journey sound immense. One big trick was to find a combination of food-grade natural polymers that could cross-link together in a 3-D form to expand properly, Sannino says. Then there was the need to make it absorbent enough. The next big challenge was making the particles sensitive to ever-changing pH conditions they encounter from the stomach through the intestines. And the latest task has been to set up an efficient production system.

Gelesis isn’t saying where the material comes from for the hydrogel particle, or how much the raw material costs. But it does provide “nice commercial margins,” based on the models Gelesis is using for what such a drug might cost in the marketplace, Elenko says.

Interestingly, even though this product is taken in a capsule, Gelesis believes it could technically be considered a medical device, not a drug, by the FDA. That’s an important distinction to make, since the material works mechanically to treat obesity, rather than being absorbed into the blood like a drug. If the capsules are considered a device, that would change the regulatory pathway Gelesis would need to clear before reaching the U.S. market.

So what did the clinical trial show in detail? The study enrolled 95 people at Gemelli Hospital in Rome, Italy. The average person had a body-mass index of 31, the equivalent of someone who’s 5-foot-6 and weighs 190 pounds. They took a placebo, or … Next Page »

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29 responses to “Obesity Capsule From Gelesis, Made to Swell Up in the Stomach, Passes First Human Trial”

  1. steve says:

    Very useful and hopefully cheaper then putting a knot in someones stomach

  2. JustCallMeCloud says:

    I’ve also invented a way to lower the obesity “epidemic”. Its called eating healthy food and exercising. I know, it sounds crazy, but it works. Here is a complex equation to demonstrate the above.
    Calories Gain – Calories Used = Fat burnt

    I would include a pie chart but I don’t want anyone eating it.

  3. KJ says:

    Do the polymer molecules actually degrade? If not, won’t this produce another constant stream of plastic molecules entering and polluting the oceans? For problems with the plastic in the oceans see algalita.org.

    It seems unlikely that people will be able to stop using this once they start because they’ll become accustomed to always feeling full.

  4. Razele Warren says:

    Can anyone tell me if Attiva is available yet to the general public? I just cam across a site that offers a similar product call FORM and wonder if this is the same thing.

  5. Razele–no, Attiva is not available on the market.

  6. Razele Warren says:

    I am very interested in this product. However, I worry about its safety. Particularly, on whether there have been any studies on rats that show no cancer after long-term use? I make this comment on the basis of silicon breast causing cancer.

  7. Razele Warren says:

    Can anyone tell me whether Attiva will be available as either a prescription or non-prescription.

    Also, can anyone tell me when Gelesis will re-present to the FDA again. I’m growing fatter by the day.

  8. Thomas Aquino says:

    A year an five months have gone by since this article was published. It is old news. Any news about the second trial?

  9. Razele Warren says:

    How much longer do we need to wait before this is made available. I mean, what else does Gelesis need to be do? Is there a second trial in the pipeline?

  10. Val Jacobs says:

    Just wondering what precautions are being taken for those who have a difficult time swallowing pills should one of the “edible water beads” get stuck in the throat and start swelling before it reaches the stomach?

    Second point, perhaps should have been the first, people who overeat do not stop eating when they feel full, otherwise they wouldn’t have become overweight in the first place. Will the stomach lose its capacity to stretch because these water beads are inside instead of food?

  11. xoom says:

    Any updates on this product?

    I’m trying to understand how a product of this nature is taking so long to reach market? It’s NOT absorbed into the bloodstream; therefore, it can’t be considered a pharmaceutical product. It’s mechanical in nature, so it can’t be governed by the same, strict, FDA regulations that apply to systemic drugs like Qnexa, and it’s certainly not the first product of its kind. Appesat expands in the stomach (albeit poorly) and it’s available today. The precedent for this series of products is set, so why is Gelesis f**king the dog?

  12. cookie says:

    Excellent studies and informaiton. I hope to try this out when its made available!