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 tolerat

SUBMITTER: Byrne JP 

PROVIDER: S-EPMC12724022 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature