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Plenity Efficacy

A proven complement to a patient’s diet and exercise efforts.1

The Gelesis Loss of Weight (GLOW) study

IN GLOW, A 6-MONTH TRIAL

~6 out of 10 adult responders achieved a ≥5% weight loss.*,2

Those 6 out of 10 lost an average of:1,2
  • ~10% of total body weight1,2
  • ~22 lbs1,2

*The GLOW pivotal study was a 6-month, multicenter, randomized, double-blind, placebo-controlled pivotal trial assessing the safety and efficacy of Plenity. Plenity (n=223) or placebo (n=213) was administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. Primary endpoints: 1) at least 35% of patients on Plenity achieving ≥5% weight loss, and 2) whether individuals receiving Plenity lost 3% more of their body weight than individuals receiving placebo.1

Orange slice

IN GLOW, A 6-MONTH TRIAL

1 in 4 adults were super responders who achieved ≥10% weight loss.*,2

Those 1 in 4 lost an average of:1-3
  • ~14% of total body weight1-3
  • ~30 lbs1-3

*The GLOW pivotal study was a 6-month, multicenter, randomized, double-blind, placebo-controlled pivotal trial assessing the safety and efficacy of Plenity. Plenity (n=223) or placebo (n=213) was administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. Primary endpoints: 1) at least 35% of patients on Plenity achieving ≥5% weight loss, and 2) whether individuals receiving Plenity lost 3% more of their body weight than individuals receiving placebo.1

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Study Design

GLOW Study

GLOW key inclusion criteria1-3

GLOW key exclusion criteria2,3

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GLOW-EX, a 6-month extension of the pivotal trial²

Sustained weight loss demonstrated to 1 year.1-2

Patients initially treated with Plenity who continued with treatment successfully maintained their weight loss for a total of 12 months.

Super Responder Sustained weight loss

Additional weight loss with Plenity.1,2

Patients initially treated with placebo and switched to Plenity achieved incremental weight loss and maintained it for an additional 6 months.

Additional Weight Loss Chart

GLOW-EX study design

In a patient survey conducted in a real-world setting, a majority of responders:*

78%

agreed or strongly agreed that Plenity helped them feel less hungry (n=40)3

75%

reported feeling somewhat satisfied or satisfied after meals (n=38)3

71%

stated Plenity started working for them within the first 4 weeks (n=36)3

Survey overview3

*Unpublished data from the Plenity Invitation Only Program. All results are self-reported. Data do not reflect full participant sample. Represents responses at week 30 (n=51).3

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Intended Use

Plenity® is indicated to aid weight management in adults with excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m², when used in conjunction with diet and exercise.

 

Important Safety Information

  • Plenity is contraindicated in patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide
  • Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully
  • Avoid use in patients with: esophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); and complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility
  • Use with caution in patients with active gastrointestinal conditions such as gastro-esophageal reflux disease (GERD), ulcers, or heartburn
  • The overall incidence of AEs in the Plenity group was no different than the placebo group
  • The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence

Rx Only. For the safe and proper use of Plenity, refer to the Healthcare Professional Instructions for Use.

References:
  1. Plenity (Instructions for Use). Boston, MA: Gelesis, Inc.; 2021.
  2. Greenway FL, Aronne LJ, RabenA, et al. A randomized, double-blind, placebo-controlled study of Gelesis100: a novel nonsystemicoral hydrogel for weight loss. Obesity. 2019;27(2):205–216.
  3. Data on file. Gelesis, Inc.

BMI=body mass index; FPG=fasting plasma glucose; GI=gastrointestinal; HCP=healthcare provider; HbA1c=hemoglobin A1c; LDL-C=low-density lipoprotein cholesterol; T2D=type 2 diabetes; TG=triglycerides.