#United States #Bofanglutide #Bridgewater, N.J. #Gan & Lee #GLP-1 RA

Gan & Lee Pharmaceuticals Launches Phase 2 Clinical Trial for Bofanglutide Injection in the US

On March 10, 2025, Gan & Lee Pharmaceuticals made a significant announcement regarding its new drug, Bofanglutide (research code GZR18). The company revealed that the first participant has been successfully dosed in a Phase 2 clinical trial aiming to evaluate the efficacy and safety of this injection in individuals dealing with overweight and obesity in the United States.

Bofanglutide functions as a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), independently developed by Gan & Lee. This clinical trial is noteworthy as it features the first head-to-head comparison between Bofanglutide and Tirzepatide, a leading treatment in the weight management landscape. This innovative approach underscores Gan & Lee's ambition to offer effective alternatives for individuals struggling with weight management.

The Phase 2 trial, registered under ClinicalTrials.gov with the number NCT06737042, is designed to include a total of 285 subjects. Participants will be randomly assigned to receive either 24 mg, 36 mg, or 48 mg doses of Bofanglutide bi-weekly, or 15 mg of Tirzepatide once weekly, along with a placebo group. The primary goal of the study is to assess the percentage change in body weight recorded from the baseline at the trial's conclusion.

In the previous Phase 1 trials (NCT06548997), Bofanglutide showcased promising safety profiles, demonstrating good tolerability among American subjects. These early results hinted at its potential not only to lower glucose levels but also to assist with weight loss effectively.

This Phase 2 trial marks a pivotal moment for Gan & Lee as it seeks to establish a competitive foothold in the global weight management market, ultimately aiming to provide improved treatment options for those battling anxiety, emotional distress, and health complications related to obesity.

About Bofanglutide (GZR18)

Bofanglutide, known as RD Code GZR18, is a bi-weekly injection designed for glycemic control in adults managing type 2 diabetes while also addressing body weight management for those classified as overweight or obese. Early indicators from clinical trials suggest that Bofanglutide exhibits efficacy in promoting weight loss competitive with, if not superior to, existing therapies in the market. Notably, it maintains a safety and tolerability profile consistent with other GLP-1 RAs.

Future Aspirations

The launch of Bofanglutide is a crucial part of Gan & Lee Pharmaceuticals' broader vision as they aim for comprehensive coverage across various treatment avenues in diabetes management. With a strong history, including producing China’s first domestic insulin analogs, Gan & Lee is poised to scale their operations internationally, striving to become a world-class pharmaceutical entity dedicated to developing innovative solutions for metabolic and cardiovascular diseases. The company gained significant attention when its disposable pen needle product received FDA approval in the US in 2020 and GMP inspection approval from the EMA in 2024.

In closing, the progress of Bofanglutide marks a notable step forward, not just for Gan & Lee Pharmaceuticals but for patients around the world who strive to manage their weight and improve their overall health.