Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study
Authors' conclusion
The Epitomee capsule is a safe and efficacious nonpharmacological option for weight management with potential broad application in participants with overweight or obesity.
Study context
- Population
- Adults with overweight or obesity, baseline BMI 27.0 to 40.0 kg/m²
- Participants
- 138 vs 141
- Comparison
- Epitomee capsule vs placebo, as adjunct to high-intensity lifestyle intervention
- Epitomeen = 138
- Placebon = 141reference
- Primary endpoint
- Co-primary: % change from baseline in body weight (Epitomee vs placebo); proportion of Epitomee-treated patients achieving ≥5% weight loss vs a 35% threshold
- Follow-up
- Week 24
Methodological detailsprospective, double-blind, placebo-controlled, pivotal
- Prospective
- Double-blind
- Placebo-controlled
- Pivotal
Primary result
As reported in the abstract
% change in body weight from baseline
| Group | Value | Least-squares mean (SE) |
|---|---|---|
| Epitomee | mean −6.6% (SD 6.5%) | −6.1% (0.6%) |
| Placebo | mean −4.6% (SD 4.7%) | −4.2% (0.6%) |
Value
Epitomeemean −6.6% (SD 6.5%)
Placebomean −4.6% (SD 4.7%)
Least-squares mean (SE)
Epitomee−6.1% (0.6%)
Placebo−4.2% (0.6%)
- Epitomee vs Placebo: P = 0.0054
- Epitomee-treated attaining ≥5% weight loss, significantly greater than the 35% predefined threshold (p < 0.0001)
- 56%
Further findings
≥10% weight loss
Safety
Device-related serious adverse events (primary safety endpoint)
- Device-related serious adverse events
- 0
Adverse events
- Adverse event rates were similar between the groups
Original publication
Efficacy and safety of a novel oral hydrogel capsule in adults with overweight or obesity: the pivotal randomized RESET study. Obesity (Silver Spring). Published 4 February 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →