TOPLINE:

Sirona, an oral gastro-retentive hydrogel, is well tolerated, leading only to mild gastrointestinal side effects, and produces sustained reductions in body weight and dietary intake.

METHODOLOGY:

• Hydrogels, valued for their biochemical inertness, are being explored for obesity treatments. Sirona is a dual-network polymer that expands in the stomach and has demonstrated appetite suppression and multiday gastric retention in a first-in-human prospective study.
• Researchers conducted a randomized, double-blind trial at three UK centers to assess the feasibility, tolerability, safety, and preliminary efficacy of Sirona in adults aged 18-65 years with a BMI of 30-40.
• Participants were randomly assigned in a 3:1 ratio to receive either Sirona or a placebo for 12 weeks, followed by a 12-week open-label extension during which all received Sirona.
• Dosing began with one pill every other day and escalated to a maximum of two pills daily taken with 250 mL of water on an empty stomach. Study visits occurred at baseline, week 6, week 13, and week 25 or 26 after completing treatment.
• Primary endpoints included feasibility (recruitment, adherence, and retention), tolerability (dose compliance and patient experience), and safety (adverse events). Efficacy was assessed by weight loss and dietary intake.

TAKEAWAY:

• Overall, 29 participants received Sirona, and 10 received a placebo (mean age, 40.6 years; 76.9% female).
• Over 95% adhered to the dosing schedule, 94.7% completed the 12-week period, and 89.5% completed the full 24-week course. Most participants found the Sirona pills tolerable to swallow.
• No serious adverse events were reported. Mild gastrointestinal effects were the most common and did not require medical intervention.
• At 12 weeks, mean total body weight loss was greater with Sirona than placebo (3.8% vs 1.0%; Hedge’s g, -1.0), with continued weight loss observed at 24 weeks (4.4% from baseline).
• Mean daily dietary intake decreased by 382.5 kcal at 12 weeks in the Sirona group and was maintained at 24 weeks.

IN PRACTICE:

“Sirona has potential as a nonpharmacological treatment for weight management, encompassing initial weight loss and weight-loss maintenance through long-term use, to be tested in larger trials,” the authors wrote.

SOURCE:

This study was led by James P. Byrne of the University Hospital Southampton in Southampton, England. It was published online in Obesity.

LIMITATIONS:

The small pilot sample limited generalizability. The 3:1 randomization resulted in only eight individuals completing the placebo regimen. The 12-week randomized phase may have been inadequate to assess longer-term efficacy and safety.

DISCLOSURES:

Sirona was developed by Oxford Medical Products Ltd., which supported the study alongside an Innovate UK Biomedical Catalyst grant. Several authors reported receiving institutional grants, part-time employment, consulting fees, having stock options, and other financial ties with Oxford Medical Products Ltd. and multiple other pharmaceutical and healthcare organizations.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.