Obesity and being overweight affect a significant portion of the adult population, with many individuals seeking effective weight loss solutions. While diet and exercise are fundamental, their success can be limited by factors like emotional eating and lack of support. In recent years, Plenity has emerged as an FDA-cleared weight loss device offering a novel approach to weight management.
Understanding the Weight Loss Challenge
Four in 10 women are obese, and over 2 in 10 are overweight, adding up to 6 in 10 women who are overweight or obese. Maintaining an optimal weight is crucial for overall health, reducing the risk of heart disease, hypertension, stroke, and diabetes. However, losing weight can be challenging, with many adults struggling with excess weight or obesity and turning to various diets.
What is Plenity?
Plenity is an FDA-cleared weight management device designed to aid adults with excess weight or obesity, specifically those with a Body Mass Index (BMI) of 25 to 40 kg/m2, in conjunction with diet and exercise. It is not a drug but rather a device composed of cellulose and citric acid. It is made by biotherapeutics company Gelesis, which was founded by CEO Yishai Zohar in 2006.
How Plenity Works
Plenity capsules contain thousands of hydrogel particles that absorb water in the body, forming three-dimensional beads. These beads mix with ingested food, increasing the volume and bulk of the meal without adding calories. This creates a feeling of fullness, potentially leading to reduced food intake.
According to Dr. Chiquette, Plenity maintains its shape and structure throughout the digestive process, continuing to increase in volume and bulk in the small intestines before breaking down in the large intestine.
Read also: A Guide to the MIND Diet
The recommended usage involves taking three capsules with 16 ounces of water 20 minutes before lunch and dinner. Since Plenity is not a drug, it doesn't interfere with the brain or other internal organs.
Clinical Trial Results
The Gelesis Loss Of Weight (GLOW) trial, a randomized, double-blind, placebo-controlled, multi-center trial, evaluated Plenity's effectiveness. The study involved 324 adults with excess weight or obesity, with or without type 2 diabetes, and with a BMI between 27 and 40 over 24 weeks (six months).
Approximately six out of 10 participants lost at least 5% of their body weight. Those in the placebo group lost 4.4% of body weight and those taking the active capsules lost 6.4%. Adjusting for differences including starting weight, age and gender, said Leider, there was a 2% weight loss over placebo.
In the GLOW study, those drinking water and the placebo also lost weight and water's free.
The Gelesis Loss of Weight (GLOW) study (1) provided an assessment of the safety and efficacy of this device, which was referred to as Gelesis100 in the study, in patients who were overweight or obese, with or without type 2 diabetes. This was a 24-week, multicenter, randomized, double-blind, placebo-controlled study. It included patients 22-65 years of age (mean age 48 years), with a mean BMI of 34 kg/m2 and fasting blood glucose levels of 90-145 mg/dL. Patients in the trial were randomized to receive either the treatment (n = 223) or placebo (n = 213). For the trial’s 24-week duration, patients self-administered three capsules containing either Gelesis100 2.25 g or a placebo with 500 mL of water 20-30 minutes before lunch and dinner in conjunction with a reduced-calorie diet of 300 kcal/day below their calculated energy requirement. These patients were instructed to perform daily moderate-intensity exercise and maintain their smoking habits during the study. Mean weight loss was 6.4% in the treatment group compared with 4.4% in the placebo group (P = 0.0007) (1). Significantly more patients in the treatment group achieved ≥5% weight loss compared with those in the placebo group (59 vs. 42%), and 27% of patients in the treatment group lost ≥10% of their body weight compared with 15% in the placebo group (1). The overall incidence of adverse events in the treatment group was no different than in the placebo group, with adverse events in both groups being mild or moderate.
Read also: Comprehensive Guide to the MIND Diet
The Gelesis Loss of Weight 24-Week Extension (GLOW-EX) study (1) evaluated the effectiveness of the treatment over a 48-week exposure, while also assessing the weight loss benefit of adding the treatment after patients had successful weight loss with lifestyle modifications (placebo group) over the initial 24 weeks. At the time of the extension study, there were 52 eligible patients left in the original study who had lost ≥3% of their body weight from baseline. Of these, 39 were enrolled in the GLOW-EX study (21 from the original treatment group and 18 from the original placebo group). Those continuing the treatment had a mean weight loss of 7.6% after 48 weeks, up from 7.1% in the initial 24-week trial (1). Patients who had prediabetes or drug-naive type 2 diabetes and an A1C <8.5% were included among the participants in the GLOW study. In the initial 24-week trial, 32 patients in the treatment group and 36 patients in the placebo group met one of these criteria. The mean percentages of change in body weight from baseline to 24 weeks were -8.1 and -5.6% for the treatment and placebo groups, respectively (1).
Side Effects
In clinical trials, the most commonly reported side effects among Plenity users were diarrhea, flatulence, infrequent bowel movements, and bloating. However, these side effects were statistically similar to those experienced by the placebo group.
Tummy side effects were common, 43% in the active pill group and 34% in the placebo, but that's how the pills work. In the GLOW study, adverse events in both groups being mild or moderate.
It should be used with caution in patients with a history of gastroesophageal reflux disease, ulcers, or heartburn (2). It should be avoided in patients with a history of any esophageal abnormality, suspected strictures (Crohn’s disease), or any previous gastrointestinal (GI) surgery that may have altered motility through the GI tract (2).
Plenity vs. Other Weight Loss Options
Several weight loss medications are available, some of which have demonstrated more significant weight loss results than Plenity. For example, Semaglutide (Ozempic) has shown up to 14.9% body weight loss, while Tirzepatide has demonstrated a 22.5% reduction in body weight in a phase 3 trial.
Read also: The Hoxsey Diet
However, Plenity distinguishes itself by being a device rather than a medication. This means it is not absorbed into the system, potentially reducing the risk of systemic side effects.
Who Should Consider Plenity?
Plenity may be a suitable option for individuals who:
- Have a BMI of 25 to 40 kg/m2.
- Are committed to making dietary and lifestyle changes.
- Are looking for a non-systemic weight loss aid.
- Tend to be volume eaters and struggle with feeling full.
Dr. Fitch says because Plenity isn’t a medication, it’s not absorbed into your system, which means patients won’t have the typical side effects that may come from a medication administered systemically. “I also particularly use it in patients who tend to be volume eaters, as the device takes up space in the stomach and therefore helps to improve a feeling of fullness at meal times that some patients tend to struggle with,” says Dr.
It is recommended that it is an aid in weight management in conjunction with diet and exercise. We encourage patients to contribute to diet prudently and focus on exercise because we know it is going to help people be successful. Nothing is the silver bullet. This is a new tool in our armoury.
How to Obtain Plenity
Plenity is available by prescription and can be obtained through a physician or via an online consultation with one of Plenity's physicians at myplenity.com. Gelesis has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers.
Patients must answer questions about their health and experiences trying to lose weight. Pregnant patients, people younger than 22, and those allergic to Plenity's ingredients should not take it.
Cost and Availability
Plenity is purchased as a subscription, with free, unlimited follow-up visits. The treatment is generally not covered by insurance. The treatment is a $98-a-month weight loss treatment that looks like a drug: Patients take three capsules twice a day. But it isn't a drug.
Important Considerations
- Lifestyle Changes: Plenity is most effective when combined with a reduced-calorie diet and regular exercise.
- Eating Patterns: Plenity may be more beneficial for those who consume most of their calories at lunch and dinner rather than snacking throughout the day.
- Individual Results: Weight loss results can vary, and Plenity may not be effective for everyone.
- Underlying Causes: Addressing the root causes of weight gain is crucial for long-term success.
- Professional Advice: Consulting with a healthcare professional is essential to determine if Plenity is appropriate and to discuss potential risks and benefits.
If you’re trying to lose weight, you’ve probably heard over and over again that eating a healthy diet and exercising regularly play key roles in helping you achieve your goal. And research shows maintaining an optimal weight is an important component of your overall health: It decreases risk of heart disease, hypertension, stroke and diabetes. But losing weight isn’t always easy, especially if you struggle with emotional eating or your efforts aren’t supported by friends and family.
The Future of Plenity
Gelesis could seek over-the-counter status, he added.