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

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2 grams of the Gelesis product in five oral tablets, with a glass of water before breakfast, lunch, and dinner. They were asked to fill out a questionnaire immediately after their meal, 30 minutes later, and an hour afterward.

The people reported that they felt an increasing sense of fullness (known formally as satiety) after each meal, and that when it was taken before lunch, people felt significantly less hungry at dinnertime. The feeling of hunger didn’t completely go away between breakfast and lunchtime, researchers posited, because people didn’t eat as much at breakfast to fill up their stomach and get the full benefit of the hydrogel.

The treatment was safe and well-tolerated, researchers said. About 16 percent of the people studied reported at least one symptom across the treatment and placebo group. About 7 percent reported nausea, about 4 percent complained of constipation or stomach ache, while just one person reported diarrhea. The incidence of side effects was similar to what overweight people often experience in placebo groups of similar trials.

Of course, this was just the first clinical trial for Gelesis, so it wasn’t really designed to measure the treatment’s effectiveness. Any treatment for weight loss is going to have to show it can help people lose weight over a yearlong period, according to the FDA’s current guidelines for obesity drugmakers. And that treatment aspires to help people who are moderately overweight—not the morbidly obese. Since overweight people have a less severe condition, the FDA is going to want to ensure any new therapy has a very clean safety profile. And there is at least one well-financed competitor, Lexington, MA-based GI Dynamics, which is also pursuing the promise of a device that’s a less-invasive alternative to gastric bypass surgery.

The Gelesis team knows all that, and is thinking hard about the next steps. The company has some government grants and partners providing non-dilutive sources of capital, and it is in strong enough financial shape that it doesn’t need to raise another venture round anytime soon, Zohar says. The company is considering the next steps in clinical development.

But these sound like heady times at Gelesis. The co-inventor, Sannino, said he has tried the product out himself, outside of the rigorous setting of a clinical trial. A few of the Gelesis investors have too, just, I suppose, as part of doing thorough due diligence. “It is quite surprising how you feel,” Sannino says. “It was like having eaten a plate full of spaghetti.”

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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!