Unmet Needs in
Weight Management

Introduction
to Plenity

GLOW
Trial Design

GLOW & GLOW-EX
Efficacy
Assessment

GLOW Safety Assessment

Key Takeaways
From Experts

Introduction and
Navigation Instructions for
Plenity Immersive Clinical
Talking Paper

What Is Plenity?

How Does Plenity Work?

Introduction
to Plenity

GLOW Trial Design
and Methods

Baseline Demographics
and Characteristics of
Patients in GLOW

Summary of
GLOW Trial Design
and Methods

Patients Taking
Plenity Achieved
Clinically
Meaningful
Weight Loss: 59%
Lost ≥5% of Their
Body Weight

Early Weight Loss
Predicted a Clinically
Meaningful
Response (≥5%
Weight Loss)

Weight Loss Was Maintained in
Responders (n=21) for an Additional
24 Weeks in GLOW-EX

Summary of GLOW
Trial Results

Plenity Demonstrated
a Highly Favorable
Safety and Tolerability
Profile in the
GLOW Study

There Were Fewer
Overall Dropouts
in the Plenity
Group vs the
Placebo Group

Aside From Gastrointestinal Adverse
Events, There Were No Differences in the
Overall Incidence of Any Adverse Events
Between Groups

Summary of GLOW
Safety Results

Key Publication HCP Instructions for Use
INTENDED USE & Important
Safety Information
References

Key Publication

HCP Instructions for Use

Intended Use

Plenity® is indicated to aid weight management in adults with excess weight or obesity, 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 Physician Instructions for Use.

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 (n=223) and placebo (n=213) were administered to 436 adults with excess weight or obesity, with or without type 2 diabetes. Adults were randomized to
2.25g 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 nonresponders, which may allow for an early prediction of response to therapy. More specifically, in this
posthoc 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-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).