THE FIRST OF ITS KIND

Plenity is FDA cleared for the largest number of adults struggling with overweight and obesity (BMI 25-40 kg/m2) of any prescription weight-management aid.1-4

  • There are ~150 million adults in the US with BMIs between 25 and 40 kg/m2. More than half are classified as overweight (BMI 25-30 kg/m2) and, until now, many of them had no prescription options
  • Plenity can be prescribed to adults with a BMI as low as 25 kg/m2, with or without comorbidities such as hypertension, type 2 diabetes, and/or dyslipidemia

The Difference

Plenity is a device that fills a need for those looking for an effective weight-management option that is not a drug or stimulant and has side effects similar to placebo.1,2

  • Indicated to aid in weight management in overweight and obese adults, with a BMI as low as 25 kg/m2 and up to 40 kg/m2, when used in conjunction with diet and exercise
  • Demonstrated effectiveness in multiple clinical studies*†
  • Safety profile similar to placebo
  • Not habit-forming or addictive
  • No restrictions on how long Plenity can be used

Plenity is made from two naturally derived building blocks—cellulose and citric acid.1,2

  • Not absorbed systemically and eliminated in the same manner as food
  • Taken twice a day orally, 20 minutes before lunch and dinner. In clinical trials, Plenity was taken with 16 ounces of water
Packaging shown for representation purposes only. Actual packaging design may vary. Plenity is not yet available for sale.
Graphic of 1 dose, 16 oz. of water and 1 prescription box. Plenity® is an effective weight management option that is not a drug or stimulant and has side effects similar to placebo.

Mechanism of Action

See how Plenity works

Efficacy

In the pivotal trial conducted up to a year, people who remained on Plenity were able to lose weight and keep it off with continued use.1,2

The safety and efficacy of Plenity were studied in the GLOW pivotal trial* and the GLOW-EX extension trial.

  • In GLOW, a 6-month trial1,2,5 *:
~6 out of 10 adults treated with Plenity were responders, achieving ≥5% weight loss (an average weight loss of 10% or ~22 pounds)
Graphic showing 6 of 10 patients, indicating the number of responders—adults taking Plenity ® who achieved 5% or more weight loss during the 6 month pivotal trial, GLOW.
1 in 4 adults treated with Plenity were super responders, achieving ≥10% weight loss (an average weight loss of 14% or ~30 pounds)
Graphic showing 6 of 10 patients, indicating the number of responders—adults taking Plenity ® who achieved 5% or more weight loss during the 6 month pivotal trial, GLOW.

The two co-primary endpoints calculated from baseline to month 6 were: 1) ≥35% of individuals taking Plenity achieving ≥5% weight loss (categorical endpoint), and 2) a placebo-adjusted weight loss assessed two ways—super-superiority margin of 3% and simple superiority over placebo. The study met and exceeded the categorical endpoint. It did not achieve super-superiority; however, it did achieve superiority over placebo (−6.4% vs −4.4%, P=0.0007). Individuals taking Plenity had twice the odds of achieving ≥5% weight loss vs placebo (adjusted odds ratio [OR] was 2.0 [P=0.0008]).

There was a clear and early separation between responders and non-responders, which may allow for an early prediction of response to therapy. More specifically, in this post-hoc analysis, weight loss of at least 3% as early as after 8 weeks of treatment predicted clinically meaningful weight loss at 6 months, with sensitivity and specificity levels exceeding 80%.

GLOW study design
  • In GLOW-EX, a 6-month extension trial:

Adults treated with Plenity in GLOW who continued taking it successfully maintained their weight loss for a total of 12 months (n=21).

GLOW-EX study design

Safety

In GLOW, Plenity demonstrated a highly favorable safety and tolerability profile.1,2

  • No difference in overall incidence of adverse events (AEs) vs placebo
  • The most common (>5%) gastrointestinal AEs in the Plenity group were abdominal pain, constipation, flatulence, infrequent bowel movements, abdominal distension, diarrhea, and nausea
  • 95% of AEs were mild or moderate in intensity, occurred within the first 3 months, and resolved within 2 weeks
  • No serious adverse events were observed in the Plenity group
  • Low drop-out rate due to AEs (3.6% in the Plenity group vs 3.3% in the placebo group)

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*The Gelesis Loss Of Weight (GLOW) study was a 6-month, multicenter, randomized, double-blind, placebo-controlled pivotal trial assessing the safety and efficacy of Plenity. Plenity was administered to 436 overweight and obese adults, with or without T2D. Adults were randomized to 2.25 g of Plenity or placebo and were prescribed reduced caloric intake and exercise. The co-primary endpoints were percent change in body weight and the percentage of responders (patients who lost ≥5% of body weight) from baseline at week 24. The study did not meet the predefined super-superiority margin of 3% compared with placebo. However, adults taking Plenity achieved statistically superior weight loss compared with the placebo group (−6% vs −4%, respectively; P=0.0007), meeting the prespecified endpoint. 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 percentage of patients who lost ≥10% body weight was included as an additional prespecified endpoint.1,2

GLOW-EX was a 6-month open-label extension study for adults who completed treatment (placebo or Plenity) and lost ≥3% of their body weight from baseline (N=39). The objective of the study was to evaluate the safety of long-term exposure (1 year) to Plenity and the effectiveness of Plenity in maintaining weight loss achieved after 6 months (combined with lifestyle modification).1,2

Read the GLOW and GLOW-EX article, winner of an Obesity Editors' Choice award.
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INDICATION AND IMPORTANT SAFETY INFORMATION