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Aim: This 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. Methods: This 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. Results: At 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Microneedle containing miniature robots offer a promising route for gastrointestinal administration since their capability of transmucosal delivery and controllable drug release. However, many challenges still lie ahead such as the intricate control modes, destitute systematic theory of the locomotion and adhesion behaviors, failure due to peristalsis and fluid flow, and risk of ileus. Herein, an untethered microneedle containing robots is designed for specific colonic administration, which can dispense with control systems, achieve fast self‐orientation and adhesion onto the mucosa (<0.6 s), against physiology of peristalsis, and show low risks of obstruction. Further, the detachable layer between the microneedle and the robots can degrade under a time of 6 min, which ensures safely discharge under a small, excreted force of 20 mN induced by fluid flow. Through the optimism of microneedles, different drug release times can be achieved including 14 min, 2 days, 4 days, and 30 days, respectively. The in vivo experiments also demonstrate the effectiveness and feasibility of the robots. These robots can serve as a versatile platform to treat diseases such as chronic inflammation and cancer of the colon to minimize invasive surgical intervention and patient suffering. [ABSTRACT FROM AUTHOR]

Molecular assembly of protein and peptide is highly specific and frequently occurs in biological systems. Collagen, which is the most abundant component in extracellular matrix, can assemble into fiber and play an essential role in cell adhesion and growth. Since native collagen is difficult to modify and can engender pathogenic and immunological side effects, its application on tissue regeneration is limited. The preparation of collagen-mimetic materials, hence, is gaining interest in the field of tissue regeneration. Collagen peptides have been synthesized to mimic some properties of collagen, such as its triple helix. However, few studies have been done to prepare artificial collagen fiber to mimic its high-level structure and biofunctions. In this work, a novel collagen-mimetic peptide amphiphile (CPA) was prepared by conjugating a single hydrophobic tail with a collagen-mimetic peptide, supplemented with bioactive glycine-phenylalanine-hydroxyproline-glycine-glutamate-arginine (GFOGER). The physical studies indicated that the CPA had a collagen-mimetic triple-helical conformation and was able to self-assemble into nanofiber. In addition, the CPA conjugated with the integrin-specific GFOGER sequence was shown to promote collagen-mimetic cell adhesion and development. The self-assembled peptide nanofiber was shown to have the ability to structurally and biologically mimic native collagen fiber. We anticipate that this artificial collagen fiber holds great potential as collagen-mimetic materials for tissue regeneration applications.