The future of weight loss may be a gelatinous glob the consistency of tapioca.
A Cambridge startup has designed a pill made of particles derived from food that, when swallowed with water, swell into a blob of gel that fills the stomach and curbs the appetite for several hours, before dissipating harmlessly in the digestive system.
Although pumping iron and downing broccoli will always be the gold standards for weight loss and health, Gelesis and other innovative companies are exploring novel ways to help people shed pounds without relying solely on willpower or more radical interventions such as surgery.
Other recent inventions include a sleeve-like plastic barrier made by Lexington-based GI Dynamics that is inserted over a portion of the small intestine to limit the absorption of food; a balloon device from ReShape Medicalof San Clemente, Calif., that is inflated inside the stomach to promote fullness and discourage overeating; and a system that uses electrical impulses in the digestive tract to simulate fullness.
Dr. Lee Kaplan, director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital, said the new devices add an important dimension to the growing arsenal in the war against fat.
“What we’ll ultimately get to is a whole toolbox of different therapies — devices, lifestyle modifications, medications and surgery — that will have a real benefit,” he said.
The four devices are all less invasive than bariatric surgery, which can involve removing a portion of the stomach or other rerouting of the body’s plumbing.
Though shown to be effective, surgery is also expensive, can have serious side effects, and often isn’t reimbursed by insurance.
None of the four new approaches works through chemical means, like a medication, so they have a lower burden of evidence needed to win approval from the Food and Drug Administration.
The Gelesis100 pill as well as EndoBarrier from GI Dynamics could be ready for consideration by the FDA in 2017, according to executives from the companies.
Meanwhile, earlier in June an FDA panel voted to recommend premarket approval for a therapy developed by EnteroMedics, of St. Paul, that uses electrical impulses to inhibit an abdominal nerve that regulates the digestive system. The FDA itself is expected to rule on the system, called vagal blocking therapy, or VBLOC, by the end of this year.
Also this year, the FDA is expected to review the ReShape Duo balloon device, which was approved for use in Europe in 2007. The balloon is usually left in place for six months.
EndoBarrier, from GI Dynamics, is also installed in the body for a short period of time — up to about a year.
It too has been approved for use in overseas markets: Europe, Australia, South America, and Israel.
Gelesis100 ‘looks like an interesting concept, [but] we need to wait for a bigger trial.’
The barrier is installed through an endoscopy in the first 2 feet of the small intestine; since the small intestines are about 20 feet long, the device doesn’t affect the body’s ability to draw nutrients from food.
The barrier attempts to mimic the same effects of one form of bariatric surgery that reduces the size of the stomach to a small pouch. Dr. David Maggs, an endocrinologist and chief medical officer at GI Dynamics, said EndoBarrier appears to change the molecular signaling from the gut to the rest of the body, altering hormones and improving symptoms of Type 2 diabetes along with promoting weight loss.
“Without anybody truly understanding the exact mechanisms at play, the device was designed to replicate that simple bypass, and we do see some replication of the bariatric surgery effects,” Maggs said.
So far, he added, EndoBarrier is “relatively well tolerated” by most patients.
GI Dynamics is currently enrolling volunteers in a pivotal trial of EndoBarrier at 25 sites in the United States, including Massachusetts General Hospital and Boston Medical Center. Maggs said he expects the trial to be completed in early 2016, with the company hoping to ask the FDA for review shortly thereafter.
Gelesis100, meanwhile, is a little easier to swallow. The food-grade particles combine with water to expand a hundredfold into tapioca-like gel. Within a few hours of being inside the stomach, the gel partially degrades, releasing most of its water, and then passes through the digestive system.
Gelesis released a study of the pill this month that said participants safely lost about 6 percent of their body weight over 12 weeks, slightly more than those taking a placebo.
Well over half of those who had been prediabetic at the start of the trial had normal blood sugar levels at the end, said Gelesis’s chief executive, Yishai Zohar. That effect, in particular, shows Gelesis100 has benefits beyond simply making people full, he said. Like fiber-rich foods, the gel takes a long time to digest, slowing down the gastrointestinal process and causing fewer spikes in blood sugar.
Dr. Osama Hamdy, medical director of the Joslin Diabetes Center’s Obesity Clinical Program, said the idea of Gelesis100 is appealing, though he’s not yet convinced.
“It looks like an interesting concept,” Hamdy said. But, “we need to wait for a bigger trial.” Gelesis intends to start a larger research trial soon in the United States and abroad.
Hamdy also worries about the safety of such devices, saying they “are still speculative, and side effects are still high.”
He’s no fan of surgery, either, instead advocating lifestyle change for weight loss such as one that Joslin pioneered, WhyWAIT, in which more than half of the patients have lost 9 percent of their weight and kept it off for five years.
But Kaplan, who has consulted to both GI Dynamics and Gelesis, said the United States, where one in three is obese and 29 million people have Type 2 diabetes, could use more help losing weight.
“The more of these therapies we have,” Kaplan said, “the more likely it is that each patient is going to have a successful approach.”