Obesity Treated With Expandable Oral Capsules
Overview
This clinical trial aimed to evaluate the efficacy and safety of administering 2.24 g intragastric expandable capsules twice daily for weight management in adults with overweight or obesity. The study, conducted as a double-blind, placebo-controlled trial, enrolled 280 participants with a body mass index (BMI) ranging from 24 to 40 kg/m2 from six hospitals in China. Participants were randomly assigned in a 1:1 ratio to receive either intragastric expandable capsules or placebo for a duration of 24 weeks.
The coprimary endpoints of the trial were the percentage change in body weight from baseline and the rate of weight reduction of ≥5%. Results showed that participants who received intragastric expandable capsules experienced a statistically significant reduction in body weight compared to those who received placebo. The mean body weight change at week 24 was −4.9% in the intragastric expandable capsule group versus −1.9% in the placebo group, with a significant estimated treatment difference (ETD) of −3.0%. Similarly, a higher percentage of participants in the intragastric expandable capsule group achieved weight loss exceeding 5% compared to the placebo group (45.0% vs. 19.7%).
Additionally, waist circumference significantly decreased in the intragastric expandable capsule group compared to the placebo group. The most common adverse events associated with intragastric expandable capsules were gastrointestinal disorders, although most were mild and transient.
In conclusion, the findings of this trial suggest that administering 2.24 g intragastric expandable capsules twice daily over 24 weeks resulted in a clinically meaningful reduction in body weight compared to placebo among adults with overweight or obesity. These results contribute to the understanding of potential interventions for weight management in this population.
Introduction
Obesity poses significant health risks, including type 2 diabetes, cardiovascular disease, mood disorders, and cancer. While lifestyle changes and dietary modifications are commonly recommended for weight loss, they often fail in the long term. Pharmacotherapies like orlistat, phentermine, lorcaserin, liraglutide, and semaglutide have shown effectiveness but may come with side effects. In China, orlistat is the only approved weight loss medication due to its mild adverse effects, yet its efficacy is limited. With China’s growing overweight and obese population, there is a pressing need for diverse weight management options.
Intragastric expandable capsules, composed of natural components, form a polymer matrix that absorbs water and expands in the stomach and small intestine, inducing satiety. Each capsule contains cellulose-based hydrogel particles and is taken orally with water before meals. Upon ingestion, the hydrogel expands, reducing food intake. The gel degrades in the colon, releasing water for reabsorption, and is excreted through defecation. Similar weight loss devices like Plenity have shown efficacy and safety in clinical trials.
This study aimed to assess the efficacy and safety of oral intragastric expandable capsules compared to placebo for weight management in adults with overweight or obesity.
Methods
This phase 3 clinical trial aimed to assess the efficacy and safety of 2.24g intragastric expandable capsules compared to placebo in promoting weight loss among adults aged 18-60 years with a body mass index (BMI) of at least 24 kg/m2. The study, conducted at six hospitals in China, adhered to ethical guidelines and obtained approval from relevant institutional review boards.
Participants were randomly assigned to receive either the intragastric expandable capsules or placebo for 24 weeks, along with diet and exercise interventions provided by dietitians. The capsules were taken orally twice daily before lunch and dinner, with lifestyle counseling provided periodically. Primary outcomes included the percentage of participants achieving at least 5% weight loss and the percentage change in body weight from baseline to week 24.
Secondary outcomes included changes in waist circumference, lipid profile, glucose levels, insulin levels, glycated hemoglobin levels, and quality of life as assessed by the EQ-5D questionnaire. Safety assessments included monitoring of vital signs, laboratory results, and adverse events, particularly gastrointestinal disorders.
Statistical analysis aimed to demonstrate the superiority of the intragastric capsules over placebo for weight loss, with a sample size of 280 participants to achieve adequate statistical power. Efficacy outcomes were analyzed using intention-to-treat and per protocol analyses, while safety outcomes were assessed in the safety analysis set. Statistical significance was determined based on confidence intervals and appropriate hypothesis testing methods.
Overall, the study followed rigorous methodologies to evaluate the efficacy and safety of intragastric expandable capsules for weight loss, providing valuable insights for future interventions targeting obesity management.
Result
In this clinical trial, researchers enrolled and randomized 280 participants into two groups: the intragastric expandable capsule group and the placebo group, after screening a total of 316 individuals. The participants’ demographics, including age, gender distribution, body weight, BMI, and waist circumference, were similar between the two groups, ensuring a balanced baseline for comparison.
The primary endpoint of the study, focusing on the mean body weight change at week 24, revealed a substantial reduction in body weight in the intragastric expandable capsule group compared to the placebo group. This significant difference persisted when analyzing both the full analysis set and the per protocol set, indicating the effectiveness of the intragastric expandable capsules in inducing weight loss over the 24-week period. Furthermore, the weight loss superiority of the active treatment group became more pronounced at week 24, suggesting sustained efficacy throughout the trial duration.
An important secondary finding was the proportion of participants achieving clinically meaningful weight reductions of over 5% and 10% of their baseline weight. The intragastric expandable capsule group demonstrated significantly higher rates of achieving these weight loss milestones compared to the placebo group, underscoring the clinical relevance of the treatment in promoting substantial weight loss.
Moreover, improvements in waist circumference and BMI were observed in the intragastric expandable capsule group at week 24, further supporting the beneficial effects of the intervention on body composition and obesity-related parameters.
Metabolic indicators, including fasting insulin levels and blood pressure, also showed favorable responses to treatment, with significant reductions observed in the intragastric expandable capsule group compared to placebo at week 24. These findings suggest potential metabolic benefits associated with weight loss induced by the intragastric expandable capsules.
Compliance analysis revealed high adherence to the study protocol in both treatment groups, indicating good participant compliance and protocol adherence throughout the trial.
Regarding safety, adverse events were reported in both groups, with gastrointestinal disorders being the most commonly reported. However, the incidence of serious adverse events was low and comparable between the intragastric expandable capsule and placebo groups, suggesting that the intervention was well-tolerated overall.
In conclusion, this study provides robust evidence supporting the efficacy and safety of intragastric expandable capsules for weight loss in individuals with obesity. The findings underscore the potential of this intervention as a valuable tool in the management of obesity and its associated metabolic complications. Further research may elucidate the long-term effects and durability of weight loss achieved with intragastric expandable capsules, as well as their potential impact on reducing obesity-related morbidity and mortality.
Conclusion
The study demonstrated the effectiveness of once-daily oral intragastric expandable capsules, combined with counseling for diet and physical activity, in achieving significant weight reduction at week 24 compared to placebo, with mild gastrointestinal adverse events.
Obesity is a chronic condition associated with various health risks, including type 2 diabetes, hypertension, and certain cancers. While bariatric surgery is an option for severe obesity, its widespread use is limited by cost and invasiveness. Lifestyle interventions such as diet and exercise often yield variable results. However, existing medications for obesity treatment are limited in China.
The intragastric expandable capsules contain food-grade hydrogel that expands in the stomach, enhancing satiety and reducing gastric volume. This mechanism, similar to FDA-approved oral superabsorbent hydrogel Plenity, helps in weight management. The capsules degrade in the colon and are excreted through defecation, minimizing systemic effects.
The study found a significant reduction in weight and waist circumference with intragastric expandable capsules compared to placebo. While the weight loss achieved was moderate compared to other treatments like semaglutide, it was comparable to Plenity and orlistat. Importantly, adverse events associated with the capsules were mild and transient, affirming their safety profile.
Limitations of the study include the potential bias of participants with a higher motivation for weight reduction and a relatively low representation of individuals with type 2 diabetes. Nonetheless, the findings support the use of intragastric expandable capsules as a safe and effective option for weight management in individuals with overweight or obesity.
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