PLENITY® is an orally administered, non-stimulant, non-systemic aid to weight management with a highly favorable safety and efficacy profile demonstrated in clinical studies1,2

CLINICAL RESULTS FROM GLOW:

A 6-MONTH PIVOTAL STUDY1,2

RESPONDERS — ADULTS ACHIEVING 5% OR GREATER WEIGHT LOSS
• 59% of adults with overweight or obesity had a clinically meaningful response to Plenity®, losing on average 10% of their weight (22 pounds) or ~3.5 inches from their waist. • PLENITY® doubled the odds of achieving 5% or greater weight loss compared with placebo

GLOW CLINICAL STUDY DETAILS

*The Gelesis Loss of Weight (GLOW) study was a 24-week, 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 type 2 diabetes. Adults were randomized to 2.25 g of Plenity® or placebo and were prescribed reduced caloric intake and exercise. 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 in two ways: super-superiority margin of 3% and simple superiority over placebo. The study met and exceeded the categorical endpoint (59% achieved ≥5% weight loss). 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]).

IN AN ADDITIONAL ANALYSIS1.2*

SUPER RESPONDERS — ADULTS ACHIEVING 10% OR GREATER WEIGHT LOSS*

26% of adults with overweight or obesity were super-responders to PLENITY®, losing on average 14% of their weight (30 pounds)*
*Prespecified ITT-Observed result

IN A POST-HOC ANALYSIS, EARLY WEIGHT LOSS PREDICTED LONGER TERM BENEFIT

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, weight loss of ≥3% as early as after 8 weeks of treatment predicted clinically meaningful weight loss at 6 months, with sensitivity and specificity levels exceeding 80%.

ADVERSE EVENTS

• In the 24-week GLOW pivotal trial assessment period, the overall incidence of adverse events (AEs) in the Plenity® treatment group was no different than placebo (71% in both groups) and most AEs (>95%) were assessed as mild or moderate in both groups. There were no serious adverse events (SAEs) in the Plenity® group versus one (1) SAE in the placebo group. The number of patients with any AE leading to study withdrawal was similar between groups. No deaths occurred during the trial. • The most common AEs were gastrointestinal disorders (43% Plenity® compared 34% placebo group), infections and infestations (33% Plenity® compared to 33% placebo group), and musculoskeletal and connective tissue disorders (14% Plenity® group compared to 16% placebo group). • Only the category of gastrointestinal (GI) related to Plenity® was different relative to placebo (38% versus 28%) respectively. GI events included abdominal distension, abdominal pain, constipation, diarrhea, flatulence, infrequent bowel movements, and nausea.
FEATURED PUBLICATION

PLENITY® is FDA cleared for the largest number of adults struggling with overweight and obesity (BMI 25-40 kg/m²) in combination with diet and exercise

 

 

 

 

 

 

HOW PLENITY® WORKS1

Plenity® is administered as capsules prior to a meal.
After swallowing Plenity®, you should drink water.
Plenity® particles hydrate in the stomach, then mix with food to create more volume.
Plenity® particles maintain their gel form and volume as they pass throughout the small intestine.
As Plenity® particles degrade in the colon, water is released and reabsorbed in the colon.
Degraded Plenity® pass through the colon and are eliminated in the bowel movement.
See how PLENITY® works

INTENDED USE

Plenity® is indicated to aid in weight management in overweight and obese adults with 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 oxide

• PLENITY® may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully

• Avoid use in patients with the following conditions: esophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); or complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility

• Use with caution in patients with: active GI conditions such as gastro-esophageal reflux disease (GERD), ulcers, or heartburn

• Overall, the most common treatment related adverse events (TRAEs) were GI-related TRAEs with 38% of adults in the PLENITY® group and 28% of adults in the placebo group experiencing a GI-related TRAE.

• The overall incidence of AEs in the PLENITY® group was no different than the placebo group

Rx Only. For the safe and proper use of PLENITY®, refer to the Instructions for Use.

References: 1. Plenity® [instructions for use]. Boston, MA: Gelesis, Inc.; 2019. 2. 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.

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