Plenity is a non-systemic medical device that complements pharmacological obesity treatments by enabling early intervention, supporting weight trajectory stabilization after systemic discontinuation, and addressing patients not eligible for systemic
Treat earlier
Lower the threshold for access to clinical care
Treat longer
Ensure therapeutic continuity and maintenance tools
Treat more people
Extend the scope beyond the boundaries of systemic therapies
PLENITY® is FDA cleared and CE Marked for the largest number of adults struggling with overweight and obesity (BMI 25-40 kg/m²) in combination with diet and exercise
Key findings from GLOW Clinical Study
Randomized, double blind, multicenter control trial.
Responders
~10% of weight loss at 24 weeks
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
Super responders
~14% of weight loss at 24 weeks
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
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%.
Safety: Plenity had no overall increased risks versus placebo, no serious adverse events.
Plenity demonstrated to be
Bio-mimetic non systemic
Effective
Highly safe
Metabolic and Lipid Parameters in the GLOW Clinical Study
Improvements in insulin Resistance Observed in the GLOW study
Analysis of metabolic parameters and subgroups in the 24-week randomized GLOW clinical study
Reduction in HOMA-IR (insulin resistance)
Participants with Fasting Plasma Glucose ≥90mg/dL
Statistically significant difference between groups
Partecipants with Fasting Plasma Glucose: >90mg/dL and insulin ≥10mU/mL
Greater effects observed in participants with higher insulin resistance
Weight-loss non-responders* with fasting plasma glucose ≥ 90 mg/dL and fasting insulin ≥ 10 μU/mL
Improvement in insulin sensitivity observed even among participants with limited weight loss. Represents a statistically significant difference between groups
*Non-responder PLENITY group (mean weight loss of 1,5%)
Plenity contributes to
Reducing insulin resistance
Improving insulin sensitivity
Supporting metabolic health
Lipid parameter Analysis in the GLOW Study
Changes in LDL-C and triglycerides observed in participants with elevated baseline values
LDL-C Reduction
Participants with LDL-C > 130mg/dL at baseline. Represents a statistically significant difference from baseline and between groups.
*Represents significantly different from baseline.
Triglyceride reduction
Participants with triglycerides >150mg/dL at baseline.
*Represents significantly different from baseline.
Numerically greater reduction compared with Placebo
Plenity contributes to
Reducing LDL-C in individuals with elevated levels
Numerically reducing triglycerides
Supporting cardiometabolic health
Where to find Plenity
Who can take Plenity®?
Plenity® is indicated to aid in weight management in adults with excess weight or obesity, with a Body Mass Index (BMI) of 25 to 40 kg/m2, when used in conjunction with diet and exercise
Important safety information
You cannot take Plenity® if you:
- are pregnant
- have had allergic reactions to cellulose, citric acid, sodium stearyl fumarate, porcine gelatin, or titanium dioxide.
To avoid impact on the absorption of medications:
- For all medications that should be taken with food, take them after starting a meal.
- For all medications that should be taken without food (on an empty stomach), take them at least 2 hours before or after consuming Plenity® and a meal.
Contact a doctor right away if problems occur. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity® until you can speak with your doctor.
In clinical trials, side effects with Plenity® were similar in number to placebo (sugar pill). The majority of side effects that did occur were mild or moderate and resolved within the first few weeks. The most common side effects were diarrhea, bloating, infrequent bowel movements, and flatulence.