A Randomized, Double-Blind, Placebo-Controlled Pilot Trial With Open-Label Extension of Sirona, a Hydrogel for Weight Loss

Abstract

Objective: This study investigated the safety, tolerability, and preliminary efficacy of Sirona, a novel gastro-retentive, dual-network polymer for weight management. Methods: This pilot trial comprised a randomized, parallel-group, double-blind, placebo-controlled (3:1 ratio), 12-week period, with a 12-week open-label extension (OLE), in participants with BMI of 30–40 kg/m2. Primary endpoints were feasibility, tolerability, and safety; secondary endpoints included weight loss and dietary intake, tested using Hedge's g [95% CI] as a measure of effect size. Results: Participants received Sirona (n = 29/38) or Placebo (n = 9/38) (mean [SD] age = 40.9 [8.4]; weight = 101.7 [12.9] kg; BMI = 35.6 [3.0]; 29/38 female and 23/38 White British). Dosing was well tolerated (RCT Sirona: 95.2 [11.0]%; RCT Placebo: 97.8 [3.5]%; RCT + OLE Sirona: 93.1 [13.0]%). No serious adverse events occurred. Of the adverse events, nausea was most prominent (74.8%), mostly graded mild (79.3%) and requiring no intervention (84.4%). Percentage total body weight loss was greater for Sirona compared to Placebo after 12 weeks (3.9 [3.0]% versus 1.0 [2.1]%, g = 0.96 [−1.81, −0.10]). Weight loss continued in the OLE (change from baseline = 4.4 [3.8]%). Dietary intake reduced from baseline after 12 weeks of treatment (−382.5 [519.3] kcal; Placebo = 93.5 [670.3] kcal, g = −0.8 [−1.7, 0.0]) and after 24 weeks (−338.2 [486.7] kcal, g = 0.7 [0.2, 1.1]). Conclusions: Sirona was well tolerated, with mild, primarily gastrointestinal side effects. Reduced weight and dietary intake suggest Sirona is suitable as a nonpharmacological treatment for weight management. Trial Registration: ISRCTN14083641 (https://doi.org/10.1186/ISRCTN14083641).