The "edible billboard" was first, which appeared in New York's East Village last year and featured cake-laden treats. In January, the national marketing campaign was launched with TV and digital media, promoting the notion that losing weight does not mean you can't have fun eating.
These ads promote Plenity, a product that can help dieters get rid of their woes. The $98 per month weight loss treatment looks like a drug. Patients take three capsules twice daily. It isn't a medication. Its success rate in losing weight is, on average, modest.
FDA approved Plenity as a device. It contains sugar-sized grains and a plant-based absorbent hydrogel. Each grain expands to about 100 times its original size, filling approximately a quarter of an individual's stomach. They must be consumed with at least two cups of water, and the three capsules should not exceed 20 minutes before being eaten. The gel is not absorbed by the body and eventually leaves in stool.
Insurance generally does not cover the cost of treatment.
Dr. Harry Leider is chief medical officer and executive vice-president of Gelesis, which makes Plenity.
While it is less expensive than other prescription weight loss therapies, it is still not affordable for those with low incomes, Jena Shaw Tronieri, assistant professor and director of clinical service at the University of Pennsylvania's Center for Weight and Eating Disorders, said.
Plenity is designed for patients who are looking to eat less. It is similar to eating a large salad before lunch, but without any actual raw vegetables.
The new prescription medication joins an increasing number of weight loss and obesity treatment options, including old-school oral drugs that are often cheap generics, as well as brand-name injectable diabetic drugs that have been repurposed for weight loss. The results varied greatly among the trial participants. 59% of those who received Plenity lost at most 5% of their bodyweight, while the rest didn't meet that threshold.
Plenity is a form cellulose that has an active ingredient. It allows people to feel fuller before they eat a main meal and reduce the amount of calories they ingest. Tronieri said that studies have shown that if you eat broth-based soups or vegetables before eating, you feel fuller and eat less. Tronieri noted that water does not produce the same satisfying effect as broth-based soups and vegetables.
However, patients still "say they hate vegetables" so capsules make it easier, said Dr. Christina Nguyen. She is the medical director of obesity medicine at Northeast Georgia Health System. Although she is not associated with Gelesis, she has been prescribing Plenity ever since its soft launch in the latter part of 2020.
Gelesis has so far credited the marketing campaign for helping it gain 40,000 new customers within the first three months, increasing its revenue by $7.5 million, even though the company lost money the first quarter.
This is the latest treatment that could be used to help obese or overweight adults in America.
"I'm happy to see it on market, but I tend want more weight loss for patients than what this device is looking at," stated W. Timothy Garvey (University of Alabama-Birmingham professor and director of the university’s Diabetes Research Center).
Gelesis reported that Plenity users who participated in its clinical trial had an average weight loss rate of 6.4%. This is higher than the 5% recommended by many doctors. This would be almost 13 pounds for a 200-pound individual. This is still a small improvement on the 4.4% average weight loss that participants in the six-month trial who were given a placebo experienced. The diets were 300 calories per day lower than what they needed to maintain their weight for each of the 436 participants.
Nguyen stated that she advises her patients to change their eating habits and exercise routines or Plenity will not work. She said, "You need to be realistic and have expectations." Plenity has shown me weight loss of approximately 5%.
It has very few side effects, primarily gastrointestinal like bloating, nausea or constipation. The FDA approved it for use by people with lower body masses than is required for prescription drugs.
Plenity's weight loss average is comparable or lower than other oral medications. It is also far less than the cost of newer additions to market like Novo Nordisk’s Wegovy, which costs $1,300 per month and is a once-a week injection. Clinical trials have shown that Wegovy helped patients shed nearly 15% of their bodyweight over 17 months. Eli Lilly announced in April that patients experienced a weight loss of 22.5% with an injectable drug they are testing. June 4th brought more details.
Gelesis said that "We don’t see Wegovy a competitor."
Leider does not view weight loss products that are available without a prescription in the same way as other competitors.
Gelesis requested FDA approval for the treatment. Gelesis may seek out over-the-counter status "once we have built the brand," he said.
He noted that weight loss with Plenity, like other treatments, can be very variable. According to study data, 27% of patients who received the treatment were considered "superresponders," losing an average 14% of their weight. Patients with prediabetes or diabetes may respond better to the treatment than patients with normal blood sugar levels.
However, 40% of the participants did not find it to be effective.
"If it takes you two months to lose weight, it might not be the right therapy for you," Leider stated.
Patients can request plenity from their doctors. Gelesis gives potential patients an alternative option to traditional treatments. They can request the treatment online, and skip an in-office visit. Ro, a direct to-patient platform, has been partnered by Gelesis. Ro provides online health assessments for its affiliated doctors and delivers treatment to eligible patients. Ro, a large buyer of Plenity in late 2021, placed a $30 million pre-paid order.
Ro, originally called Roman, was launched in 2017. It initially focused on male health concerns such as erectile dysfunction (and hair loss) and then expanded to include other conditions. Since then, it has expanded to include other conditions.
Ro offers online consultations for free with doctors, even if you are looking to lose weight. Patients will need to answer questions about their personal health and experience in losing weight. Patients who are pregnant, those under 22 years old, and people allergic to Plenity ingredients should not use it.
Ro's information is not protected by the federal privacy law, the Health Insurance Portability and Accountability Act or HIPAA. However, CEO Zachariah Reitano stated that all data is kept in HIPAA-compliant ways.
Ro added Plenity because of its clinical trial results, and because it saw a potential business opportunity in weight loss. Reitano stated that customers asked for help with "challenges in weight management".
Rene Morales, a patient, said that even though his insurance doesn't cover it, the $98 per month he spends on coffee is well worth it. Gelesis allowed Rene Morales to speak with him. He stated that if he spends so much on coffee, he can use it to improve my health.
After his doctor mentioned it during his annual physical, Morales began taking Plenity in January. Morales stated that he has lost 15 lbs from his initial weight of almost 280 pounds, and wants to continue the treatment until he loses 30.
Morales stated that the treatment has helped him to rethink his perception of food and to focus on smaller portions. "I've come [to] the realization that you don’t have to stack your plates up to enjoy your food."
KHN (Kaiser Health News), a national newsroom, produces in-depth journalism on health issues. KHN, along with Policy Analysis and Polling are the three main operating programs of KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information to the nation on health issues.
