S788 Oral Super-Absorbent Hydrogel Capsules Double Clinically Meaningful Weight Loss Without Added Serious or GI Adverse Events: A Systematic Review and Meta Analysis of Randomized Controlled Trials

Introduction: The obesity epidemic continues to outpace the capacity of pharmacologic and endoscopic therapies, many of which carry systemic effects, high cost, or procedural risk. Oral super-absorbent hydrogel (OSH) capsules—an ingestible, non-systemic biomaterial that swells in the stomach to promote satiety—were recently cleared by the FDA yet remain under-recognized in gastroenterology practice. By taking 3 placebo-controlled randomized controlled trials (RCTs) with a total of 990 participants, we aimed to provide the first high-certainty estimate of OSH-mediated weight loss and to clarify its safety profile. Methods: A systematic search of PubMed, Embase, Scopus, and Cochrane Library identified RCTs that compares the efficacy and safety of OSH versus placebo for weight loss through May 2025. Data were analysed using RevMan 4.2.1. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using Mantel-Haenszel methods. Random- or fixed-effects models were applied based on heterogeneity (Higgins’ I²). Statistical significance was set at P < 0.05. Risk of bias was assessed using RoB 2.0. Results: Across 3 RCTs (n = 990) with overweight or obesity, oral super-absorbent hydrogel capsules (n = 501) achieved superior efficacy and comparable safety versus placebo: ≥5% weight loss occurred in 54% vs 36% of participants (RR 1.54, 95% CI 1.16–2.03; I² = 70%), and ≥10% weight loss in 24% vs 11% (RR 2.24, 95% CI 1.66–3.02; I² = 30%); no device-related serious adverse events were reported and overall SAEs were rare (0/501 vs 4/489; RR 0.19, 95% CI 0.02–1.65), while gastrointestinal side-effects (31% vs 27%; RR 1.11, 95% CI 0.82–1.50; I² = 54%) and discontinuations for adverse events (1.6% vs 2.2%; RR 0.71, 95% CI 0.29–1.76; I² = 0%) were similar. Conclusion: Our analysis shows that OSH nearly doubles the likelihood of achieving ≥10% body-weight loss within 24 weeks while preserving a placebo-like rate of serious or treatment-limiting adverse events—an efficacy-to-safety balance that rivals early experience with glucagon-like peptide-1 analogues but without systemic exposure. Although moderate heterogeneity was observed for the ≥5% threshold, effect direction was uniformly favorable, and no single trial drove the result, underscoring the robustness of the finding. These data position OSH as a practical, non-pharmacologic adjunct for patients who are refuse drug or bariatric interventions, and they suggest a role in mitigating obesity-linked GI comorbidities (e.g., NAFLD, GERD).