Gan & Lee's Once-Weekly Insulin GZR4 Demonstrates Superior Efficacy in Phase 3 Trials
核心洞察
Gan & Lee Pharmaceuticals (搜索)' investigational once-weekly insulin GZR4 met primary endpoints in two pivotal Phase 3 trials, showing statistically significant superior HbA1c (搜索) reduction compared to daily insulin formulations.
In the SUPER-1 trial with insulin-naïve patients, GZR4 achieved a -1.45% HbA1c (搜索) reduction versus -1.22% with insulin glargine U100 (搜索), demonstrating a significant treatment difference of -0.23%.
The SUPER-2 trial in patients previously treated with basal insulin showed GZR4 reduced HbA1c (搜索) by -1.00% compared to -0.58% with insulin degludec, with a treatment difference of -0.42%.
Gan & Lee Pharmaceuticals (搜索) announced positive results from two pivotal Phase 3 clinical trials evaluating their investigational once-weekly basal insulin GZR4 Injection. The SUPER-1 and SUPER-2 trials successfully met their pre-specified primary endpoints, demonstrating statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c (搜索)) compared with established once-daily insulin formulations after 26 weeks of treatment.
SUPER-1 Trial Results in Insulin-Naïve Patients
The SUPER-1 trial, a 52-week Phase 3 treat-to-target study, enrolled 588 insulin-naïve Chinese adults with type 2 diabetes mellitus (搜索) across 84 medical sites in China. The trial compared once-weekly GZR4 with once-daily insulin glargine U100 (搜索) (Lantus®), both administered in combination with non-insulin anti-diabetic treatment.
GZR4 demonstrated statistically significant superiority in HbA1c (搜索) reduction. After 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.45% in the GZR4 group versus -1.22% in the insulin glargine U100 (搜索) group, resulting in a statistically significant estimated between-group treatment difference of -0.23%.
The once-weekly insulin also achieved a significantly higher rate of safe glycemic target attainment, outperforming the insulin glargine U100 (搜索) group on the composite endpoint of achieving HbA1c (搜索) <7.0% or ≤6.5% without experiencing clinically significant (Level 2) or severe (Level 3) hypoglycemia.
SUPER-2 Trial in Basal Insulin-Experienced Patients
The SUPER-2 trial, a 26-week Phase 3 treat-to-target study, investigated 631 Chinese adult patients with type 2 diabetes mellitus (搜索) previously treated with basal insulin across 82 medical centers in China. This trial compared once-weekly GZR4 with once-daily insulin degludec (Tresiba®), administered with or without concomitant non-insulin anti-diabetic treatment.
GZR4 demonstrated statistically significant superiority in HbA1c (搜索) reduction versus insulin degludec. After 26 weeks of treatment, the estimated mean change in HbA1c from baseline was -1.00% in the GZR4 group versus -0.58% in the insulin degludec group, achieving a statistically significant estimated between-group treatment difference of -0.42%.
Similar to SUPER-1, GZR4 delivered a significantly higher rate of safe glycemic target attainment, outperforming the insulin degludec group on the composite endpoint of achieving HbA1c (搜索) <7.0% or ≤6.5% without clinically meaningful (Level 2) or severe (Level 3) hypoglycemia.
Safety Profile and Clinical Implications
Both trials demonstrated that once-weekly GZR4 maintained a favorable safety and tolerability profile. Notably, no severe (Level 3) hypoglycemic events occurred in either treatment group across both studies.
Dr. Chen Wei from Gan & Lee Pharmaceuticals (搜索) commented on the results: "We are thrilled to report positive top-line results from the SUPER-1 and SUPER-2 trials. This robust dataset confirms that GZR4 delivers statistically significant superiority over the active comparators on the primary endpoint of HbA1c (搜索) reduction, with an overall safety profile closely aligned with that of marketed once-daily basal insulins."
Treatment Adherence and Quality of Life Benefits
Compared with once-daily formulations, once-weekly GZR4 delivers more than 85% reduction in annual injection frequency, with no need for an additional loading dose. This simplified regimen is designed to improve treatment adherence, optimize long-term glycemic control, and drive meaningful, sustained improvements in the quality of life for people living with diabetes.
Comprehensive Clinical Development Program
The SUPER program represents a large-scale global Phase 3 clinical development program for GZR4 Injection. Four Phase 3 clinical trials have been initiated in China, enrolling approximately 2,120 adults with inadequately controlled type 2 diabetes mellitus (搜索) to deliver a systematic evaluation of the efficacy and safety of once-weekly GZR4 versus once-daily basal insulins.
The program includes SUPER-3, a 26-week trial enrolling 580 patients with type 2 diabetes previously treated with basal-bolus insulin therapy, and SUPER-8, a 26-week trial enrolling 300 patients comparing GZR4 with insulin icodec (Awiqili®).
Detailed results from SUPER-1 and SUPER-2 are planned for presentation at scientific conferences and will be submitted for publication in peer-reviewed international academic journals. Additional findings from the GZR4 Injection's ongoing clinical program are expected to be released over the following 12 months.