Affiliation:
1. Department of Endocrinology Peking University First Hospital Beijing China
2. Department of Gastrointestinal Surgery Xiangya Third Hospital of Central South University Changsha China
3. Department of Endocrinology Peking University Shenzhen Hospital Shenzhen China
4. Department of Endocrinology Xiamen University First Affiliation Hospital Xiamen China
5. Department of Endocrinology Peking University Shougang Hospital Beijing China
6. Department of Endocrinology Zhongshan Hospital of Fudan University Shanghai China
7. Junion Therapeutics (Xiamen) Co. Ltd Xiamen China
Abstract
AbstractAimThis trial assessed the efficacy and safety of 2.24 g intragastric expandable capsules twice per day versus placebo for weight management in adults with overweight or obesity.MethodsThis double‐blind, placebo‐controlled study included adults with a body mass index of at least 24 kg/m2 and no more than 40 kg/m2. In total, 280 participants were recruited from six hospitals in China and were assigned in a 1:1 ratio to receive 2.24 g oral intragastric expandable capsules or placebo for 24 weeks. Coprimary endpoints were the percentage change in body weight from baseline and the rate of weight reduction of ≥5%, assessed using both the full analysis set and per protocol set.ResultsAt baseline, the mean body weight was 81.8 kg, and the mean body mass index was 29.4 kg/m2. The mean body weight change at week 24 was −4.9% with intragastric expandable capsules versus −1.9% with placebo [estimated treatment difference (ETD) −3.0%, 95% confidence interval (CI) −4.1 to −1.9; p < .001] using the full analysis set and −6.1% versus −2.5% (ETD −3.6%, 95% CI −5.0 to −2.3; p < .001), respectively, using the per protocol set. The percentage of participants who had weight loss exceeding 5% was 45.0% in the intragastric expandable capsule group versus 19.7% in the placebo group (ETD 25.3%, 95% CI 14.7‐35.9; p < .001) in the full analysis set and 55.9% versus 26.2% (ETD 29.6%, 95% CI 17.1‐42.2; p < .001), respectively, in the per protocol set. Waist circumference significantly decreased at week 24 (intragastric expandable capsules vs. placebo: −5.6 ± 8.3 cm vs. −2.9 ± 4.8 cm; p = .003). The most common adverse events associated with the use of intragastric expandable capsules were gastrointestinal disorders (intragastric expandable capsule vs. placebo, 25.0% vs. 21.9%), and most were mild and transient.ConclusionsIn 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.
Subject
Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine