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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