Gelesis100, the weight-loss device

GELESIS100 is a pill that immediately positions itself as “a new approach to the treatment of obesity” that will revolutionize all procedures adopted to date by science and medicine.

Obesity, as everyone knows, is a growing phenomenon, and a host of pharmaceutical companies and laboratories are dreaming of finding THE remedy that will enable thousands, if not millions, of people to solve their overweight problem once and for all.

Let’s take a look at what appears to be a new ray of hope for sufferers of this crippling condition.

Presentation and promises of Gelesis100

The Gelesis100 pill is, according to the manufacturer, a new generation of smart pills, and has been designed to treat the physiological symptoms of hunger, without surgery, invasive procedures or medication.

In fact, Gelesis100 presents itself as a genuine treatment for obesity and overweight, which can be used safely to induce clinically significant weight loss and improve glycemic control in overweight and obese people, including those with pre-diabetes or type 2 diabetes.

Gelesis100 acts mechanically on the stomach and intestine, and is said to have the following effects:

• Increased feeling of satiety ;
• Reduced sensation of hunger;
• Reduced calorie intake;
• Significant weight loss.

The makers of Gelesis100

Gelesis, a start-up based in Boston, USA, is behind the creation of the Gelesis100 slimming pill.

The company seems to have hit the nail on the head with its overweight-fighting product, as several major investors decided to bet big on Gelesis100 just a few years ago.

In fact, no less than 12 million dollars have been invested by pharmaceutical companies, laboratories and financiers to further research the promising effects of this slimming pill.

We can be reassured of the reliability and seriousness of the company behind Gelesis100. The data collected are relayed by recognized journals, and the information is easily verifiable.

Here’s an example of a headline that’s, to say the least, very attractive: an obesity treatment that looks like a pill, but acts like a device raises $12M from investors.

(Source: Medcity News. Medical Device. An obesity treatment that looks like a pill but acts like a device takes in $12M from investors. Article published May 16, 2014.)

Gelesis100 ingredients

Gelesis100 is a hydrogel designed to (rapidly) absorb and release water at specific sites in the gastrointestinal tract.

The hydrogel particles are synthesized by a proprietary process using a specific form of modified cellulose and citric acid. The process involves cross-linking modified cellulose with nitric acid to form a three-dimensional matrix.

Each capsule contains thousands of Gelesis100 hydrogel particles, each about the size of a grain of salt.

The 2 main ingredients, modified cellulose and citric acid, are both GRAS (Generally Recognize As Safe) designated components, which means they are recognized as safe by the FDA.

The two ingredients in Gelesis100 have the ability to retain and absorb liquids with which they come into contact. In the stomach, when in contact with digestive fluids and juices, the hydrogel capsules increase in volume by up to 100 times their initial volume, thus filling the stomach. The body sends satiety signals to the brain, which stops the feeling of hunger and the desire to eat.

But that’s not all. Gelesis100 hydrogel is not digested and dissolved by digestion. In fact, it’s designed to improve stomach elasticity, slow transit and intestinal emptying.

Once the digestive process is complete, the hydrogel particles move into the small intestine to absorb glucose from the blood. In this way, Gelesis100’s 2nd action comes into play, namely to improve glycemic control.

Finally, Gelesis100 hydrogel is transported to the large intestine, where it is broken down by enzymatic action. The water retained until then is released and reabsorbed by the body, and the hydrogel is eliminated by natural means.

Gelesis100 does not enter the bloodstream. From the stomach to the intestine, it shrinks and continues on its way, eventually to be eliminated naturally with the faeces.

The hydrogel particles mix homogeneously with the food and travel through the gastrointestinal tract, inducing satiety and improving glycemic control as they go.

Gelesis100 capsules are administered orally, but the manufacturer is arguing for its product to be regulated as a medical device, because, in its view, this hydrogel does not achieve its objective by chemical action inside or within the body, and does not need to be metabolized to function.

Scientific studies on Gelesis100

Touted as a real innovation in the fight against overweight and obesity, the makers and “sponsors” of Gelesis100 have done things by the book.

Before launching their product on the market, studies are carried out to confirm its efficacy and safety.

Gelesis100 has already successfully passed an initial human trial, the aim of which was to test the product’s tolerance.

Test subjects were asked to take 2 grams of Gelesis100 in 5 capsules, to be consumed with a large glass of water before each of the 3 meals of the day. They were then asked to complete a questionnaire immediately after the meal, then 30 minutes later, and finally 1 hour after the meal.

Subjects reported the following effects

• An increase in the feeling of satiety after each meal.

  When taken at lunchtime, Gelesis100 reduced the feeling of hunger at dinnertime.

  This effect was less marked for breakfast, as this meal was less copious and therefore less able to fill the stomach, even with the gel.

• Gelesis100 was well tolerated, and is considered harmless. It did cause some mild side effects: 7% of participants experienced mild nausea; 4% constipation or stomach upset; 1 person had diarrhea.

  (Source: Xconomy. Obesity Capsule From Gelesis, Made to Swell Up in the Stomach, Passes First Human Trial. Luke Timmerman. Published April 22, 2010.)

This first trial, which was not intended to accurately assess the efficacy of the treatment, had very encouraging results. In fact, the FDA has approved Gelesis100 as a safe and healthy product. The investors therefore decided to take the clinical studies further, with new trials currently underway, and results expected in late 2016-early 2017.

In November 2014, Gelesis launched its GLOW (Gelesis Low Of Weight) study.

This randomized, double-blind, placebo-controlled study was conducted in four European countries in parallel groups. The aim was to evaluate the effect of repeated administration of Gelesis100 on body weight and glycemic control in 168 overweight and obese patients, including pre-diabetics and those with mild type 2 diabetes.

The GLOW study endpoints are: 3% weight loss on placebo and 5% weight loss in at least 35% of patients taking Gelesis100 independently of placebo results.

Secondary endpoints include changes in key glycemic control parameters, including insulin levels, insulin resistance, fasting plasma glucose, and glycosylated hemoglobin or HbA1c.

The results of this study will be published in the first half of 2016.

The pivotal FDA trial will be launched in the second half of 2016, and data will be submitted to the FDA in the first half of 2018.

Following these milestones, Gelesis100 will be launched in the US in the first half of 2019.

To find out more, here’s the patent filed by Gelesis Inc. for its hydrogel: Patent US8658147.

Gelesis100 – side effects, price and warranty

As Gelesis100 is still in the study phase, it’s premature to talk about side effects before these trials are finalized.

Gelesis researchers are aware that overweight and obesity are associated with a number of co morbidities, including type 2 diabetes, hypertension, heart disease, and hyperchlosterolemia.

In particular, they are aware that the treatment of these diseases involves the chronic administration of different classes of orally administered drugs, including oral antidiabetics, metformin, antihypertensives, antidyslipidemics, and oral anticoagulants.

Therefore, they declare that in order to treat these patients with Gelesis100, they will be required to perform drug-device interaction studies both in vitro and if necessary in patients to ensure that Gelesis100 does not interfere with or impair the pharmacokinetic or pharmacodynamic properties of these drugs.

As Gelesis100 is not yet on the market, there is no information concerning its conditions of sale.

Will it be available on prescription only? Will its price be affordable or reserved for the more affluent?

We don’t know yet, but we’ll keep an eye out for further information.

What professionals are saying about Gelesis100

Given that this new method is still under study, we can’t talk about consumer testimonials. However, we can quote testimonials from healthcare professionals who have evaluated Gelesis100
“Gelesis technology represents a major advance in materials science. It is the first and only superabsorbent hydrogel I know of that is constructed from food ingredients and does not use potentially toxic organic solvents. By combining the properties of two components through cross-linking, Gelesis researchers have created a three-dimensional structure capable of focntioning in the gastrointestinal tract to increase satiety and reduce hunger.” Dr. Rober LANGER, MIT Professor and co-founder of PureTech Ventures.

“I’m particularly enthusiastic about the development of Gelesis. This approach is so unique that it is not only first-in-class, but rather represents a new class of therapies that has the potential to change our arsenal for treating overweight, obese, and pre-diabetic people.” Dr. Caroline Apovian FACN, Professor of Medicine and Pediatrics (Endocrinology, Diabetes and Nutrition) at Boston University School of Medicine. Clinical advisor at Gelesis.

“Gelesis100 represents a completely new approach to the treatment of obesity…Gelesis100 has the potential to provide a truly new alternative for weight loss, which does not require surgery, injections, or any other medication taken systemically.” Dr. Arne Astrup, Head of the Department of Human Nutrition, Exercise and Sports at the University of Copenhagen, Danmarque. Clinical Advisor at Gelesis.

“At a time when there is considerable unmet need in the treatment of obesity and diabetes, we see (Gelesis) as a crucial opportunity to develop a safe and effective treatment with the potential to dramatically improve outcomes.” Dr John LaMattina, Ancine President of R&D at Pfizer and Chairman of Gelesis.

“Its noveau hydrogel (Gelesis) is an innovative way to effectively increase satiety while decreasing food intake.” Dr.James HILL, Professor of Medicine and Pediatrics at the University of Colorado, former President of the Obesity Society (TOS) and Clinical Advisor at Gelesis.

Our opinion on Gelesis100

According to our survey, Gelesis100 seems to be THE product to follow and test if you want to get rid of your overweight for good. We’ll be sure to keep our readers informed of the results of the ongoing clinical trials, and of course when Gelesis100 goes on sale.

For the record, if the GLOW study is a success, Gelesis100 is scheduled to go on sale between 2018 and 2019.