Efficacy and safety of intragastric expandable oral capsules in adults with overweight or obesity: A randomized, double‐blind, placebo‐controlled trial
Authors' conclusion
In this 24-week trial including participants with overweight or obesity, 2.24 g of intragastric expandable capsules twice daily led to a clinically meaningful reduction in body weight compared with placebo.
Study context
- Population
- Adults with overweight or obesity (BMI ≥24 and ≤40 kg/m²), six hospitals in China; mean baseline weight 81.8 kg, mean BMI 29.4 kg/m²randomized 1:1
- Participants
- 280 adults
- Comparison
- 2.24 g intragastric expandable capsules twice daily vs placebo
- Primary endpoint
- Coprimary: percentage change in body weight from baseline and rate of weight reduction ≥5%
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, multicentre
- Double-blind
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
Body weight change
Intragastric expandable capsules
−4.9
mean · %
Placebo
−1.9
mean · %
Estimate (95% CI)P value
Intragastric expandable capsulesvs Placebofull analysis set
estimated treatment difference −3.0 %(−4.1 to −1.9)
P < 0.001Intragastric expandable capsulesvs Placeboper protocol set: −6.1% vs −2.5%
estimated treatment difference −3.6 %(−5.0 to −2.3)
P < 0.001Between Intragastric expandable capsules and Placebofull analysis set
estimated treatment difference (weight loss >5%: 45.0% vs 19.7%) 25.3 %(14.7–35.9)
P < 0.001Between Intragastric expandable capsules and Placeboper protocol set
estimated treatment difference (weight loss >5%: 55.9% vs 26.2%) 29.6 %(17.1–42.2)
P < 0.001Further findings
| Outcome | Intragastric expandable capsules | Placebo | P value |
|---|---|---|---|
| Waist circumference change · week 24 | −5.6 ± 8.3 cm | −2.9 ± 4.8 cm | P = 0.003 |
Safety
Gastrointestinal disorders (most common AEs) · most were mild and transient
Original publication
Efficacy and safety of intragastric expandable oral capsules in adults with overweight or obesity: A randomized, double‐blind, placebo‐controlled trial. Diabetes Obes Metab. Published 22 January 2024. doi:10.
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