A Randomized, Double‐Blind, Placebo‐Controlled Pilot Trial With Open‐Label Extension of Sirona, a Hydrogel for Weight Loss
Authors' conclusion
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.
Study context
- Population
- Participants with BMI 30–40 kg/m²; mean (SD) age 40.9 (8.4), weight 101.7 (12.9) kg, BMI 35.6 (3.0); 29/38 female, 23/38 White British
- Participants
- 38 participants
- Comparison
- Sirona vs placebo
- Sironan = 29
- Placebon = 9reference
- Primary endpoint
- Feasibility, tolerability and safety
- Follow-up
- 12 weeks
Methodological detailspilot, parallel-group, double-blind, placebo-controlled, 3:1 randomisation, 12-week open-label extension
- Pilot
- Parallel-group
- Double-blind
- Placebo-controlled
- 3:1 randomisation
- 12-week open-label extension
Primary result
As reported in the abstract
Dosing tolerability (adherence)
- Dosing well tolerated; RCT + open-label extension (OLE) Sirona
- 93.1 [13.0]%
Secondary outcomes
Percentage total body weight loss · 12 weeks · greater weight loss with Sirona
Hedge's g 0.96 (−1.81 to −0.10)
| Outcome | Sirona | Placebo | Hedge's g (95% CI) |
|---|---|---|---|
| Dietary intake change from baseline · 12 weeks | — not stated in the abstract | mean 93.5 (SD 670.3) kcal | −0.8 (−1.7 to 0.0) |
— not stated in the abstract
- Dietary intake change from baseline — Dietary intake reduced from baseline after 12 weeks of treatment
- −382.5 [519.3] kcal
Weight loss in the OLE · OLE (24 weeks)
- Weight loss continued in the OLE; change from baseline
- 4.4 [3.8]%
- Open-label extension
Dietary intake change from baseline · 24 weeks
- Dietary intake reduced from baseline after 24 weeks
- −338.2 [486.7] kcal, g = 0.7 [0.2, 1.1]
Safety
- Serious adverse events
- 0
- Nausea (most prominent AE)
- 74.8%
- Nausea graded mild
- 79.3%
- Nausea requiring no intervention
- 84.4%
Original publication
A Randomized, Double‐Blind, Placebo‐Controlled Pilot Trial With Open‐Label Extension of Sirona, a Hydrogel for Weight Loss. Obesity (Silver Spring). Published 15 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →