Efficacy and safety of intragastric expandable oral capsules in adults with overweight or obesity: A randomized, double‐blind, placebo‐controlled trial

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.