| Popis: |
Background: In a previous pilot weight-loss study, an association was observed between baseline fasting plasma glucose (FPG) levels and the effectiveness of the Gelesis100 treatment. The aim of this subanalysis of the Gelesis Loss Of Weight (GLOW; NCT02307279) study is to further assess the association between FPG and body weight (BW) responders in subjects with overweight or obesity treated with Gelesis100, a non-systemic hydrogel. Methods: This subanalysis was conducted in subjects who were overweight or had obesity and who completed the GLOW study. GLOW was a multicenter, double-blind, placebo-controlled pivotal study with subjects randomized to 2.25 g of Gelesis100 or placebo in capsules taken with 500 mL of water before lunch and dinner while on a hypocaloric diet (-300 kcal/day) for 24 weeks. BW responders at 5% and 10% (super-responders) were analyzed using Logit model comparing Gelesis100 to placebo arms in 2 subgroups of subjects defined by their initial FPG (two consecutive consistent values). Subgroup 1 had normoglycemia (FPG < 100 mg/dL) and subgroup 2 had prediabetes (PD) (FPG ≥ 100 mg/dL and < 126 mg/dL) or untreated type 2 diabetes (T2D) (FPG ≥ 126 mg/dL). Results: The population included 206 subjects (94 males, 112 females, 138 in subgroup 1, 68 in subgroup 2, 105 on Gelesis100, 101 on placebo). In subgroup 1 (mean baseline FPG = 91 mg/dL), BW responders at 5% and 10% in Gelesis100 arm were 60% (placebo arm = 34%, adjusted odds ratio (OR) = 3.1, P = 0.0022) and 22% (placebo arm = 15%, OR = 1.5, P = 0.4254), respectively. In subgroup 2 (mean baseline FPG = 113 mg/dL), BW responders at 5% and 10% in Gelesis100 arm were 72% (placebo arm = 56%, OR = 2.2, P = 0.1509) and 44% (placebo arm = 14%, OR = 6.1, P = 0.0071), respectively. In the overall population, baseline FPG was inversely correlated with BW percent change in the Gelesis100 arm (r = -0.24, P = 0.0144). The safety and tolerability of Gelesis100 demonstrated no increased risk compared to placebo. No serious adverse events were observed in any arm. Conclusion: Gelesis100 offers a compelling new approach in the management of overweight and obesity. Notably, in Gelesis100-treated subjects with PD or untreated T2D, the odds of being super-responders are 6 times higher compared to placebo. This finding may be used as a tool for identifying subjects who are both at higher clinical risk and more likely to achieve greater levels of BW loss when treated with Gelesis100. The mechanisms underlying this finding require further investigations. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO. |
