In a 24-week phase 3 randomized placebo-controlled study, oral intragastric expandable capsules have shown promising results in reducing body weight in adults with overweight or obesity. These capsules, taken twice daily before meals, expand with water in the stomach to fill about one quarter of its volume, aiding in weight loss. The study involved 280 adults aged 18-60 years with a body mass index (BMI) of ≥ 24 kg/m^2.
The primary endpoints of the study were the percentage change in body weight from baseline and the weight loss response rate (at least 5% weight loss from baseline body weight) at week 24. The results showed a higher change in mean body weight and weight loss response rate with the intragastric expandable capsules compared to placebo. Additionally, there was a greater reduction in fasting insulin levels with the capsules, although improvements in lipid profile, fasting plasma glucose levels, and heart rate were similar between the capsule and placebo groups.
Gastrointestinal disorders were reported in 25% of participants in the capsule group, which were mostly transient and mild. The study, led by Difei Lu, MD, from Peking University First Hospital in Beijing, China, and published in Diabetes, Obesity and Metabolism, suggests that these capsules offer a new, mild, and safe anti-obesity medication option. However, the study had limitations, including a focus on individuals who were more willing to lose weight and a relatively young participant group with a low percentage of type 2 diabetes, which may have limited the potential to observe metabolic or cardiovascular improvements.