Gan & Lee Reports Major Advances in Diabetes, Obesity Treatments at ADA's 84th Sessions

Gan & Lee Pharmaceuticals has announced significant findings from their Phase 1b/2a clinical trial of GZR18 Injection, a glucagon-like peptide-1 (GLP-1) receptor agonist, aimed at treating obesity. The results were shared at the 84th Scientific Sessions of the American Diabetes Association (ADA). The trial focused on Chinese subjects with obesity or overweight, evaluating the safety, tolerability, pharmacokinetics, and efficacy of GZR18 after multiple doses administered either weekly or bi-weekly.

The study enrolled 36 obese participants who were randomized to receive either GZR18 or a placebo over a period of 35 weeks. Participants in the GZR18 weekly group showed a remarkable average weight loss of 16.5 kg compared to baseline, outperforming Semaglutide and Tirzepatide in similar durations. The bi-weekly group saw a mean weight reduction of 11.3 kg. The study highlighted that 100% of participants in the weekly group achieved a weight reduction of at least 5%, with 90% and 80% achieving reductions of 10% and 15%, respectively. In contrast, none of the placebo group participants achieved a 5% weight reduction.

Safety profiles for GZR18 were favorable, with gastrointestinal adverse events being the most common, all mild to moderate in severity. No serious hypoglycemic or adverse events related to the drug were reported.

In addition to the Phase 1b/2a trial, Gan & Lee is conducting a Phase 2 study with a broader participant base and dosing range. Preliminary data from this study supports the results of the earlier trial, particularly noting the efficacy of the bi-weekly dosing regimen.

Dr. Gan Zhong-ru, the founder of Gan & Lee, expressed enthusiasm over the findings, emphasizing the unique molecular design of GZR18, which delays drug action onset and mitigates peak effects, thus improving tolerability and facilitating gradual, sustained weight loss. The drug’s extended duration of action supports bi-weekly administration, presenting a significant advantage in obesity treatment.

In addition to GZR18, Gan & Lee presented findings from preclinical studies on two other innovative insulin products: GZR4 and GZR101. GZR4, a once-weekly insulin analog, exhibited a higher affinity for human serum albumin (HSA) and maintained insulin receptor activation post-albumin binding, showing greater glucose-lowering effects in diabetic animals compared to insulin Icodec. GZR101, a premixed insulin analog combining ultra-long-acting basal insulin GZR33 and rapid-acting insulin aspart, demonstrated superior blood glucose control in diabetic animal models compared to existing insulin analogs.

These results underscore Gan & Lee’s commitment to advancing diabetes and obesity treatments. The company aims to continue developing innovative therapeutic solutions, addressing critical public health challenges associated with these conditions. Gan & Lee’s broader portfolio includes six core insulin products and two medical devices approved in China, with significant achievements in both domestic and international markets.

The ongoing and future studies of GZR18 and other products are expected to further validate these promising findings, potentially leading to new, effective treatment options for diabetes and obesity.