Plenity [Weight Loss]

Discussion in 'Men's Health Forum' started by Michael Scally MD, Apr 16, 2019.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Introducing Plenity

    Plenity is the first and only FDA-cleared weight management tool made from naturally derived building blocks—cellulose and citric acid.

    Plenity is a capsule taken with water before lunch and dinner. Plenity absorbs the water you drank and mixes with the food you eat. This makes you feel full and helps you eat less.

    With continued use, you’ll feel fuller throughout the day.

    [OA] 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 (Silver Spring, Md) 2019;27:205-16.

    OBJECTIVE: This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity.

    METHODS: The Gelesis Loss Of Weight (GLOW) study was a 24-week, multicenter, randomized, double-blind, placebo-controlled study in patients with BMI >/= 27 and </= 40 kg/m(2) and fasting plasma glucose >/= 90 and </= 145 mg/dL. The co-primary end points were placebo-adjusted weight loss (superiority and 3% margin super-superiority) and at least 35% of patients in the Gelesis100 group achieving >/= 5% weight loss.

    RESULTS: Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super-superiority. Importantly, 59% of Gelesis100-treated patients achieved weight loss of >/= 5%, and 27% achieved >/= 10% versus 42% and 15% in the placebo group, respectively. Gelesis100-treated patients had twice the odds of achieving >/= 5% and >/= 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug-naive type 2 diabetes had six times the odds of achieving >/= 10% weight loss. Gelesis100 treatment had no apparent increased safety risks.

    CONCLUSIONS: Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.