The first of its kind
- 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
- 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
- Not absorbed systemically
- Eliminated in the same manner as food
- Taken twice a day orally, 20 minutes before lunch and dinner. In clinical trials, Plenity is taken with 16 ounces of water
Plenity mechanism of action:
see how it works
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.†
††GLOW, 6-month trial and GLOW-EX, 6-month extension trial
*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; 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. The study met and exceeded the categorical endpoint. It did not achieve super-superiority. The percentage of patients who lost ≥5% of body weight was 59%. Individuals on Plenity lost on average 6% vs individuals on placebo who lost on average 4% (P=0.0007).
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
†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).1,2GLOW-EX study
- 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)
Want more information?
Plenity is an aid for weight management in adults who are overweight or obese and have a body mass index (BMI) of 25 to 40 kg/m2, when combined 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 Physician Instructions for Use.
- Plenity (instructions for use). Boston, MA: Gelesis, Inc.; 2019.
- Greenway FL, Aronne LJ, Raben A, et al. A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss. Obesity. 2019;27(2):205-216.
- Data on file. Custom analysis of NHANES raw data by Trinity Partners on behalf of Gelesis, Inc.; 2019.
- Centers for Disease Control and Prevention. Defining adult overweight and obesity. Available at https://www.cdc.gov/obesity/adult/defining.html. Accessed February 19, 2019.
- Data on file. Gelesis, Inc.; 2019.