#China #Beijing #Bofanglutide #Gan & Lee #GLP-1 RA

Gan & Lee Pharmaceuticals Launches GRADUAL-3 Clinical Trial

In an exciting development for weight management, Gan & Lee Pharmaceuticals has announced the initiation of its third large-scale Phase 3 clinical study, GRADUAL-3. This trial focuses on the bofanglutide injection, which is the first Chinese drug under the glucagon-like peptide-1 receptor agonists (GLP-1 RA) category designed to aid adults suffering from obesity and overweight issues. This innovative injection will be administered subcutaneously once a month, offering a potentially powerful option for maintaining weight loss and improving long-term adherence to treatment.

Objective of the Study

The primary goal of the GRADUAL-3 study, registered as Chinadrugtrials.org.cn CTR20254659, is to assess the efficacy and safety of the once-monthly bofanglutide injection over a 24-week period. The study will evaluate both the change in body weight, along with the percentage change from baseline at the 24-week mark. Leading this clinical effort is Professor Linong Ji from Peking University People's Hospital, ensuring that the study is in capable hands.

Previous Studies and Background

This latest phase follows the earlier trials, GRADUAL-1 and GRADUAL-2, which also tested the effectiveness of bofanglutide for weight management among adults. Notably, GRADUAL-2 was groundbreaking, being the first GLP-1 RA evaluated in a direct comparison with semaglutide (Wegovy®) on Chinese adults with obesity, regardless of type 2 diabetes status. These earlier studies played a critical role in confirming bofanglutide's efficacy and safety in treating obesity while considering its effects on various metabolic parameters and cardiovascular risks.

Significance of GRADUAL-3

The GRADUAL-3 trial aims to provide further insights into how effectively this once-monthly injection can help individuals sustain their weight loss over time—a particularly significant factor in weight management therapies where patients often face challenges like weight regain and inconsistent treatment adherence. By minimizing the frequency of injections, the study is designed to improve adherence rates which can allow individuals to experience more successful, long-term results.

Bofanglutide's Mechanism and Benefits

Bofanglutide (research code GZR18) is viewed as a promising option in the pipeline of GLP-1 RAs. Alongside its proposed indications for obesity and type 2 diabetes, it has shown exciting weight-loss and glucose-lowering effects in clinical trials while also yielding broad metabolic benefits. Importantly, the safety profile of bofanglutide aligns with that of existing marketed GLP-1 RAs, highlighting its potential viability as a treatment option. As Gan & Lee progresses through its clinical development, it firmly positions bofanglutide as a competitor in the evolving landscape of weight management treatments.

Future Directions and Community Impact

The GRADUAL clinical development program encompasses three major Phase 3 studies, each one meticulously designed to evaluate the efficacy and safety of bofanglutide in adults with obesity. With plans for over 1,000 participants in total across these studies, Gan & Lee Pharmaceuticals is committed to deeply understanding this medication's impact on addressing obesity challenges, contributing significantly to the fight against metabolic diseases. This collective effort will not only influence future treatment strategies but also has the potential to enhance patient outcomes within the broader healthcare community.

For many suffering from obesity, the promise of bofanglutide and the efforts of Gan & Lee Pharmaceuticals represent hope on the horizon—an opportunity to regain control of their health and well-being, backed by scientific research and clinical validation.