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WEIGHT MANAGEMENT

Plenity

Plenity is the first and only FDA-cleared weight management tool made from naturally derived building blocks. In clinical trials, 59% of Plenity responders lost on average of 10% of their body weight (22 pounds) in six months. Plenity is indicated to aid weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/㎡, when used in conjunction with diet and exercise.
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How it Works?

Plenity, made from naturally derived building blocks, is three capsules taken with 16 ounces (2 cups) of water before lunch and dinner. Plenity absorbs the water you drank and mixes with the food you eat. This makes you feel full and helps you eat less. With continued use, you’ll feel fuller throughout the day.

Take 3 capsules

Take three Plenity capsules before lunch and again before dinner.

Drink 16 ounces of water

Don’t just take a sip—for the capsules to take effect, you need to drink 16 oz of water with each dose.

Wait 20 minutes

You’re ready to enjoy your meal and feel full after eating smaller portions.

Why Plenity

Effective

Nearly 60% of study participants that were treated with Plenity achieved an average weight loss of 10% of their body weight or ~22 pounds.

Proven safety profile

A clinical study showed that Plenity is as safe and tolerable as a placebo (a capsule with inactive ingredients), with minor side effects.

Non-stimulant

Plenity is not a stimulant and there are no restrictions for how long it can be used.

Accessible

Plenity is safe for use by people with or without other conditions such as hypertension, type 2 diabetes, or dyslipidemia.

*The percentage of responders, a co-primary endpoint, or the percentage of patients who lost ≥5% of body weight, achieved clinically meaningful weight loss with Plenity vs placebo (59% vs 42%; P=0.0008). The study did not meet the predefined weight loss super-superiority margin of 3% over placebo.

Learn more about Plenity’s clinical trial—Gelesis loss of weight (GLOW) study

In a 24-week clinical trial called GLOW (Gelesis Loss of Weight), Plenity or placebo was given to 436 adults who were overweight or had obesity, in conjunction with diet and exercise. 

The study was designed to measure: efficacy of at least 35% of individuals receiving Plenity lost ≥5% of their body weight, and a Placebo-adjusted weight loss of ≥3%. 

There was no difference between placebo and Plenity in the overall incidence of adverse events.

Important Safety Information

Patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide should not take Plenity.

To avoid impact on the absorption of medications:

  • For all medications that should be taken with food, take them after starting a meal.
  • For all medications that should be taken without food (on an empty stomach), continue taking on an empty stomach or as recommended by your physician or nurse practitioner.

Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can speak to your doctor.

Plenity is a prescription-only therapy. For the safe and proper use of Plenity, talk to a healthcare professional or refer to the Instructions for Use.

FAQ

What is Plenity made of?
Plenity contains a hydrogel made of naturally derived building blocks, which absorbs a significant amount of water once in the stomach. Plenity is made from naturally derived substances: carboxymethyl cellulose (modified cellulose – cellulose is the fiber found in vegetables and plants) and citric acid (found in many fruits like lemons and limes).
How does Plenity work?
When Plenity is combined with water, small Plenity hydrogel particles are formed. Plenity particles are about the size of a grain of salt or sugar. After ingestion, Plenity capsules release thousands of these hydrogel particles and each particle absorbs about 100 times its weight in water. These hydrated hydrogel particles do not clump together, rather they mix with food and promote a sense of fullness.
When will I begin to lose weight?
Weight loss is a gradual process and every experience is different. But on average the sensation of fullness occurs early and is followed a few weeks later by weight loss. In clinical studies, people taking Plenity with diet and exercise had greater weight loss compared to people doing diet and exercise alone as early as 4 weeks.
Who and what is Plenity for?

Plenity has been cleared for use in adults, not in children or adolescents. Plenity aids in weight management for overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/㎡, when used in conjunction with diet and exercise. 

You can calculate your BMI by entering your height and weight into a calculator that can be found here.

What is the likelihood that Plenity will work for me?
In the pivotal GLOW study using Plenity, nearly 60% of participants achieved >= 5% body weight loss and 27% of participants achieved >= 10% body weight loss.
Do I need to be on a specific diet or exercise regimen when taking Plenity?
Having a balanced diet with 30 minutes of daily physical activity is part of a healthy lifestyle. Plenity can work with any diet or nutrition plan and since Plenity makes you feel fuller, eating less can be easier.
Is Plenity a drug?
No. Plenity is not a drug because it is not absorbed into your bloodstream, does not alter the function of your cells or your organs, and is not processed or metabolized by your liver or kidneys. Plenity is made of naturally derived building blocks that work locally in your GI tract, it is never absorbed into your body, and acts mechanically to make you feel full.
Does Plenity contain any common allergens?
Plenity does not contain or produce gluten, soy, wheat, peanuts, shellfish, lactose, dairy, sugar, alcohol, latex, or mercury. Nor does it contain any dyes, preservatives, or ingredients related to Para-Aminobenzoic Acid. Plenity is made from naturally derived substances: carboxymethyl cellulose (modified cellulose – cellulose is the fiber found in vegetables and plants) and citric acid (found in many fruits like lemons and limes).
What are the most common side effects of Plenity?
In the pivotal GLOW study, there was no overall difference between treatment and placebo group. The most common side effects of Plenity were diarrhea 13% (placebo 9%), abdominal distension 12% (placebo 7%), infrequent bowel movements 9% (placebo 5%), and flatulence 9% (placebo 5%). These gastrointestinal side effects were usually mild to moderate in intensity and resolved in a matter of days or weeks.

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