Gan & Lee Pharmaceuticals begins US Phase 2 trial of bofanglutide for obesity and weight management

Gan & Lee Pharmaceuticals (Shanghai Stock Exchange: 603087) has initiated its Phase 2 clinical trial of bofanglutide (GZR18) injection, with the first participant successfully dosed in the United States. The study aims to evaluate the efficacy and safety of this bi-weekly GLP-1 receptor agonist in adults with overweight or obesity, marking a significant milestone in the company’s weight-loss drug development pipeline.

The trial is the first head-to-head study comparing bofanglutide with tirzepatide, a widely recognized once-weekly GLP-1 receptor agonist developed for diabetes and weight management. As pharmaceutical companies race to dominate the GLP-1 receptor agonist market, Gan & Lee Pharmaceuticals is positioning bofanglutide as a novel bi-weekly treatment alternative, potentially offering greater flexibility in dosing and improved adherence for patients managing obesity.

What Makes Bofanglutide Different From Existing GLP-1 Receptor Agonists?

Bofanglutide, also referred to as GZR18, is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist developed by Gan & Lee Pharmaceuticals. Unlike existing once-weekly GLP-1 receptor agonists such as tirzepatide and semaglutide, bofanglutide is designed to be administered bi-weekly, potentially providing patients with a dosing schedule that balances the convenience of less frequent injections with more consistent therapeutic effects.

Early-stage clinical research on bofanglutide suggests it may be as effective as or superior to marketed GLP-1 receptor agonists in reducing body weight and managing blood glucose levels. Phase 1 trials demonstrated promising weight loss and glucose-lowering effects, with a safety and tolerability profile comparable to existing GLP-1 therapies. This has positioned the drug as a strong contender in the growing market for obesity treatments.

How Is the Phase 2 Trial of Bofanglutide Designed?

The ongoing Phase 2 clinical trial (NCT06737042) in the United States is designed to assess bofanglutide’s effectiveness in overweight and obese adults. The study will enroll 285 participants, who will be randomly assigned to receive bofanglutide at doses of 24 mg, 36 mg, or 48 mg bi-weekly, tirzepatide at 15 mg once weekly, or a placebo.

The primary endpoint of the study is the percentage change in body weight from baseline at the end of the treatment period, a crucial measure of the drug’s weight-loss efficacy. This trial follows the December 2024 clearance of Gan & Lee Pharmaceuticals’ Investigational New Drug (IND) application by the US Food and Drug Administration (FDA), allowing the company to proceed with clinical testing in the US market.

The results of this head-to-head trial against tirzepatide will provide critical insights into bofanglutide’s potential as a new-generation weight-loss drug, setting the stage for possible late-stage development and regulatory approvals.

Why Is the Global Obesity Market Driving Demand for New Treatments?

The demand for effective weight-loss treatments is rapidly increasing, fueled by the rising global prevalence of obesity and metabolic disorders. According to the World Obesity Federation’s 2024 Global Obesity Report, approximately 2.2 billion adults were classified as overweight in 2020, accounting for 42% of the world’s adult population. By 2035, this number is expected to reach 3.3 billion, underscoring the urgency for innovative treatments to combat obesity-related health risks.

Obesity is linked to severe complications, including type 2 diabetes, cardiovascular disease, and mental health disorders, leading to increased healthcare costs and economic burdens. The pharmaceutical industry has responded with the development of GLP-1 receptor agonists, which have shown significant potential in both blood glucose regulation and weight management.

Gan & Lee Pharmaceuticals is positioning bofanglutide as a next-generation obesity treatment, with the potential to offer better weight-loss efficacy and enhanced patient adherence compared to daily or weekly injection regimens. The company’s bi-weekly dosing approach may appeal to individuals seeking a treatment option that provides consistent therapeutic benefits while requiring fewer injections.

How Is Gan & Lee Pharmaceuticals Expanding Its Presence in the Weight-Loss Drug Market?

Gan & Lee Pharmaceuticals has established itself as a leader in diabetes treatment, having developed China’s first domestically produced insulin analog. The company currently offers six core insulin products, including long-acting, fast-acting, and mixed insulin analogs.

In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first in procurement demand for insulin analogs, highlighting its dominance in the Chinese diabetes market. The company is also expanding its global presence, with its disposable pen needle (GanleeFine) receiving US FDA approval in 2020 and European Medicines Agency (EMA) GMP certification in 2024.

Beyond diabetes care, the company is shifting its focus to obesity and metabolic diseases, developing bofanglutide as a potential market disruptor in the weight-loss drug industry. With the GLP-1 receptor agonist market experiencing exponential growth, Gan & Lee Pharmaceuticals is strategically positioning itself to compete with industry giants.

What Does the Future Hold for Bofanglutide and Gan & Lee Pharmaceuticals?

As Phase 2 trials of bofanglutide progress, Gan & Lee Pharmaceuticals is expected to release further data on efficacy, safety, and long-term weight management benefits. If successful, the drug could advance to Phase 3 trials, bringing it closer to regulatory approval and potential commercialization.

Investor interest in the GLP-1 receptor agonist market has surged, particularly following the success of semaglutide (marketed as Ozempic and Wegovy) and tirzepatide (marketed as Mounjaro and Zepbound). As a result, Gan & Lee Pharmaceuticals’ expansion into the obesity drug market is being closely watched, with bofanglutide potentially providing a new treatment option in a rapidly growing industry.

Gan & Lee Pharmaceuticals remains committed to advancing treatments for metabolic diseases, with a pipeline that extends beyond diabetes and obesity into cardiovascular diseases and other therapeutic areas. The company’s success in the bofanglutide trial could signal a breakthrough in obesity treatment, paving the way for bi-weekly GLP-1 receptor agonists to enter mainstream clinical practice.