Characteristics that make the medical device, Plenity, unique from other therapies approved for weight management.
Chris Mazzolini: The last sector of treatment I want to discuss is medical devices. We’ve had the recent FDA [Food and Drug Administration] approval of the device Plenity, which was based on the GLOW and the GLOW X trials. Dr Christofides, can you go through what Plenity is, the indications dosage and how it differs from pharmacologic agents? Can you talk about this new device?
Elena A. Christofides, M.D., FACE: Absolutely. Thank you. Plenity is an interesting product, it’s taken orally, is absorbed, and is taken as a capsule, but it’s considered a device for the very specific reason of its mechanism. Plenity is a gel that absorbs water, a hygroscopic gel, and the best way I can describe, or explain it visually, for people to understand it is if you think about gel capsules or gelatin cubes that you can buy to put in plant-soil for a planter. These capsules or gelatin cubes absorb water when you water the plant, and then releases the water out again as the plant takes in the water from the soil. That’s what Plenity is like, but obviously, it’s medical grade, and not plant grade. The purpose of Plenity is to absorb water in the body to bulk up in the stomach, where it presents as a bolus or a mass, that acts like food to distend to the stomach. One of the key features of the incretin hormones that mimetics like liraglutide [Saxenda] and semaglutide [Ozempic] is the ability of the body to allow or trigger hunger, satisfaction, satiety and lack of hunger by stretching the stomach — that’s one of the key ways these drugs work. Stretching the stomach is an important element to improving satiety and decreasing calorie intake, so when you use something like Plenity, you absorb water, expand the stomach, and trigger satiety by expanding the stomach and suggesting that there is adequate volume that been consumed, which then suppresses your appetite by the fact that it satisfies you and you no longer seek more food. As you then digest the water and it gets absorbed into your system, you release the water, you release the Plenity, and the gel gets somewhat metabolized, but also gets excreted through the small intestine to the large intestine and to your stool, where it’s then expelled. You take the gel, you absorb the water, you release the water — so you return to neutral — and then you excrete the gel through your feces. Plenity basically serves as a bulking agent. It’s not absorbed at all in the body so it’s not going to medically interfere with any medications you might be taking, unless you have a problem with a drug that might get bound in the stomach. There are other drug-to-drug interactions that you might have to worry about, not because of a metabolism issue, but because of a mechanism. You don’t want the mechanism getting sucked into the Plenity in the stomach and then making it not available for the patient. That’s the most important aspect to think about, but the mechanism is still quite brilliant, as a bulking agent. There are three capsules that come in each pod, and you take all of them before lunch and dinner, predominantly because those tend to be the largest meals of the day for an individual, so that’s why the capsules are dosed before lunch and dinner. Most people don’t eat breakfast, or they eat a very small breakfast, but if you have somebody who eats a large meal of the day as breakfast and lunch, for instance, you might move the dosage around. So you take those three capsules with a large glass of water, of course, because that’s the whole point, and you want to do that pre-meal because you want to pregame. You want to fool your body into thinking that you’ve already had a meal before you eat your meal in order to reduce the volume of food that satiates the body. This is particularly effective in people who have difficulty managing their hunger, and in people who have difficulty managing their volume of food — in terms of knowing when to stop— but obviously, caution has to be entertained for people who have gastrointestinal disease. If the patient has a lot of problems with reflux or gastrointestinal disease, or there are structural issues, you may have a conversation with the patient about whether they are a good candidate or not. Certainly, people who have had gastric bypass surgery or restructuring surgeries may not be the best fit. You may have to have a conversation with the patient to determine whether they can safely take Plenity.
Chris Mazzolini: Is Plenity considered an alternative weight loss management option?
Elena A. Christofides, M.D., FACE: I think it’s fair to say that Plenity should be considered as an adjunctive weight loss therapy for patients that you’re managing with overweight or obesity because it isn’t systemically absorbed. Plenity’s mechanism of action is easy to understand for both the patient and the clinician, so I don’t see a reason why you wouldn’t, or couldn’t, use Plenity every step of the way in managing a patient, with the exception of, obviously, the post-surgical patient. There may be a discussion about that later, but up to that point, there isn’t a reason not to consider using it every step of the way. Plenity uses the same principles as when dieticians used to tell people to drink a glass of water before they eat in order to stretch their stomach and make them feel fuller, but no one ever bought that. No one ever did that. But if you combine that glass of water with Plenity, then it might actually work.
Transcript edited for clarity.