In the GLOW study, nearly 6 out of 10 people who took Plenity lost at least 5% of their body weight. Their average weight loss was 10% (about 22 pounds). Plenity or placebo was given to 436 adults who were overweight or had obesity, with and without type 2 diabetes, over 24 weeks in conjunction with diet and exercise. The study was designed to measure: whether at least 35% of individuals receiving Plenity lost 5% of their body weight, whether individuals receiving Plenity lost 3% more of their body weight than individuals receiving placebo. Individuals on Plenity lost on average 6% vs individuals on placebo, who lost on average 4%. Though the Plenity group achieved statistically superior weight loss compared to placebo, it did not meet the predefined super-superiority margin of 3% to successfully meet this co-primary endpoint.
Plenity® is indicated to aid weight management in adults with excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m2, when used in conjunction with diet and exercise.