One capsule makes your stomach feel full; could he treat obesity?

(CNN) – A new capsule has recently been approved by the US Food and Drug Administration to help overweight or obese adults lose weight when they are used with diet and exercise, according to the biotech company Gelesis, who developed the product.

Research showing that this weight management approach has a "high safety and efficacy profile" was presented Monday at the 26th European Congress on Obesity in Glasgow, Scotland. The research was funded by Gelesis.

The company announced FDA clearance this month and said the product, called Plenity, was the only prescription weight management product approved for use in overweight adults with a mass index 25 or more.

Body mass index, or BMI, is a person's weight in kilograms divided by the square of their height in meters; the measure is used to detect obesity. A BMI of 25 to 29.9 is considered overweight, and a BMI of 30 or more is considered obese.

In the United States, nearly 40% of people aged 20 and over live with obesity.

Gelesis said that Plenity will be widely available by prescription in the United States in 2020. No cost for the product has been announced.

How it works

Even though it looks like a pill, Plenity is considered a medical device.

The hydrogel capsule can be taken with water before lunch and dinner. In the stomach, the capsule releases thousands of particles that absorb water and swell to create small individual pieces of gel. These pieces of gel increase the volume and elasticity of the stomach and small intestine, helping you feel full, which could then lead to weight loss.

Once in the large intestine, the hydrogel is partially degraded by the enzymes, loses its three-dimensional structure, releases the absorbed water and is then expelled into the stool.

"The most compelling aspects of this approach are its effectiveness, its innovative mechanism of action, and its impressive safety data," Dr. Ken Fujioka, Weight Loss Expert, Scripps Endocrinologist, said in a statement. Clinic and scientific advisor of Gelesis.

"This approach creates another arm in the weight management treatment algorithm and could be used by an overwhelming majority of people struggling with weight issues," he said.

Data from a Plenity study, published in Obesity in February, showed that treatment resulted in 6.4% weight loss in a group of 223 patients using the product, compared to 4.4% in 213 patients using a placebo. The study was funded by Gelesis.

The device should be used with caution in patients with gastrointestinal conditions, such as gastroesophageal reflux, ulcers or heartburn, according to Gelesis. The most common side effects of treatment are gastrointestinal disorders, including gastrointestinal discomfort.

Fullness is not the only aid to weight loss in recent years; several interventions are on the market.

Yet, "for the first time in a long time, this is a new treatment for obesity that does not affect the central nervous system," said Dr. Dyan Hes, medical director of Gramercy Pediatrics in New York, who sits on the board of the company. American Council of Obesity Medicine.

"So, most of the drugs on the market that suppress appetite or act on the appetite regulation system have a side effect on the central nervous system because every time you assign a neurotransmitter in the brain with regard to appetite, there will always be another systemic effect. The effect of some systems, whether they are moody or they affect depression or headaches, said Hes, who has no connection with Plenity but who is certified by the board of directors pediatrics and medicine of obesity.

"It's really, clearly, just focused on being more complete," she said. "Your stomach is going to be full, and it's excreted, and it really does not affect your central nervous system in that way."

& # 39; The wave of the future & # 39;

As a general rule, a drug can be considered effective for weight management if, after one year of treatment, at least 35% of people in the group treated with the drug (and about twice the proportion of people in the placebo group) lose at least 5% of their consumption. weight in a study or trial.

Weight loss medications approved for long-term use include orlistat (brand name Xenical), lorcaserine (Belviq) and liraglutide (Saxenda), as well as the combination medications naltrexone-bupropion (Contrave) and phentermine-topiramate (Qsymia).

In a recent study, these drugs helped overweight or obese people lose at least 5% of their body weight at the end of the year – that's at least 10 pounds if you weigh 200 – compared to a placebo . Qsymia and Saxenda were associated with the highest probabilities of achieving this level of weight loss.

For many, a loss of 5% to 10% of your body weight is associated with an improvement in blood pressure, triglycerides and blood sugar, factors that reduce the risk of heart disease and diabetes.

Hes called weight loss interventions like Plenity "the wave of the future" and she hopes the product will soon be approved for use in children.

"I see so many obese patients and I really do not have options for them," she said. "And then we have something like that, which is literally just a cellulose that you swallow and excrete. I think that the biggest problem for me in pediatrics will be able to get young children to swallow the tablets. "