The Gelesis Loss of Weight (GLOW) study
GLOW-EX, a 6-month extension of the pivotal trial²
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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 Professionals Instructions for Use.