 |
BEIJING and BRIDGEWATER, N.J., June 12, 2026 /PRNewswire/ — Gan & Lee Pharmaceuticals (hereinafter “Gan & Lee”, stockcode: 603087.SH) announced that two of its core pipeline products in the fields of diabetes and obesity treatment have recently achieved positive clinical results.
SUPER-3: Insulin Ludefen (GZR4)combined with insulin aspart demonstrated superior HbA1c reduction in adults previously treated with basal-bolus insulin or premixed/dual insulin analogs.
Insulin Ludefen is an investigational ultra-long-acting once-weekly basal insulin analog independently developed by Gan & Lee Pharmaceuticals. The drug’s pivotal Phase III clinical trial in China, SUPER-3, recently met its pre-specified primary endpoint.
SUPER-3 is a 26-week, treat-to-target, Phase 3 clinical trial conducted at 80 medical sites across China (ClinicalTrials.gov Identifier: NCT06767761). The study enrolled 596 adults with type 2 diabetes (T2DM) who had previously been treated with basal-bolus insulin, premixed insulin analogs or dual insulin analog. It evaluated once-weekly Insulin Ludefen compared with once-daily insulin glargine U100 (Lantus®) injection, both in combination with insulin aspart, with or without non-insulin antidiabetic agents.
The study met its primary endpoint. In patients with T2DM previously treated with mealtime insulin aspart, premixed insulin analogs, or dual insulin analogs, once-weekly Insulin Ludefen, used as the basal insulin component in combination with prandial insulin aspart, demonstrated superior HbA1c reduction versus once-daily insulin glargine U100. After 26 weeks of treatment, compared with the once-daily glargine insulin U100 regimen, the once-weekly Insulin Ludefen demonstrated superiority in reducing HbA1c levels (change from baseline: −1.58% vs. −1.41%); the estimated between-group treatment difference was −0.17%, and this difference was statistically significant (p=0.0021, <0.025). Additionally, Insulin Ludefen demonstrated a higher rate of safe glycemic target attainment: the once-weekly Insulin Ludefen group outperformed the once-daily insulin glargine U100 group on the clinically relevant composite endpoint of achieving HbA1c < 7.0% or ≤ 6.5% without clinically significant (level 2) or severe (level 3) hypoglycemia during the last 12 weeks.
Once-weekly Insulin Ludefen demonstrated a favorable safety and tolerability profile, with no severe (level 3) hypoglycemic events occurring in the Insulin Ludefen group, while three severe (level 3) hypoglycemic events were reported in the insulin glargine U100 group.
The SUPER-3 study focused on a more complex patient population. Compared with insulin-naive patients or those treated with basal insulin alone, patients treated with basal-bolus insulin, premixed insulin analogs, or dual insulin analogs typically had a longer disease duration, more complex treatment regimens, and a heavier daily injection burden. The positive results of the SUPER-3 study further expand the clinical evidence for Insulin Ludefen in patients at different stages of type 2 diabetes treatment, providing key support for the use of once-weekly basal insulin in intensive treatment settings.
Detailed results from the SUPER-3 study are scheduled to be presented at upcoming scientific conferences and published in international academic journals.
About the SUPER Clinical Program
The SUPER program is a large-scale global phase 3 clinical development program for Insulin Ludefen, a proposed once-weekly basal insulin by Gan & Lee. To date, four phase 3 clinical trials have been initiated in China:
SUPER-1: A 52-week trial enrolling 588 insulin-naïve adults with T2DM, comparing the efficacy and safety of once-weekly Insulin Ludefen versus once-daily insulin glargine U100 (Lantus®), both in combination with non-insulin anti-diabetic treatment. Key results after 26 weeks of treatment showed that once-weekly Insulin Ludefen was superior to once-daily glargine insulin U100 in reducing HbA1c.
SUPER-2: A 26-week trial enrolling 631 adults with T2DM previously treated with basal insulin, comparing the efficacy and safety of once-weekly Insulin Ludefen versus once-daily insulin degludec (Tresiba®), with or without concomitant non-insulin anti-diabetic treatment. Key results showed that once-weekly Insulin Ludefen was superior to once-daily degludec in reducing HbA1c.
|
*Glycated hemoglobin A1c (HbA1c): A biomarker that reflects average blood glucose levels over the preceding 2 to 3 months and is the gold-standard endpoint for evaluating the efficacy of anti-diabetic treatment. |
|
The primary efficacy endpoints were derived from the modified intention-to-treat (mITT) population under the treatment strategy, secondary efficacy endpoints from the mITT population under the hypothetical strategy, and safety endpoints from the safety set (SS) population. |
Bofanglutide injection: Key Phase 3 Study in China Meets Primary Endpoint
The GRADUAL-1 study is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study conducted in adults with overweight or obesity in China (ClinicalTrials.gov Identifier: NCT06728124). The study enrolled 640 participants who were randomized to receive bofanglutide injection 24 mg, bofanglutide injection 48 mg , or placebo once every two weeks (Q2W) for 52 weeks. Participants had a mean baseline body weight of 93.71 kg and a mean body mass index (BMI) of 33.28 kg/m², with baseline characteristics generally well-balanced across treatment groups.
The results showed that after 52 weeks of treatment, participants receiving bofanglutide injection 24 mg and 48 mg achieved mean body weight reductions of 15.12% and 18.54%, respectively, compared with 1.11% in the placebo group. In addition, 91.8% and 98.1% of participants in the bofanglutide injection 24 mg and 48 mg groups, respectively, achieved at least 5% weight loss from baseline.
In addition, bofanglutide injection also showed comprehensive improvements in cardiovascular and metabolic parameters, including waist circumference, blood pressure, triglycerides, and serum uric acid.
Regarding safety, bofanglutide injection was generally well tolerated in both the 24 mg and 48 mg groups. The safety profile was consistent with that of other GLP-1 RAs. The most common adverse events were gastrointestinal reactions and were mostly mild to moderate and transient, with no new safety signals identified.
|
The above topline results were based on analyses of the modified intention-to-treat (mITT) population and the safety set (SS). |
Meanwhile, a Phase 2 clinical trial evaluating the efficacy and safety of bofanglutide injection in overweight and obese participants in the United States has also met its primary endpoint.
This Phase 2 clinical study (NCT06737042) was a multicenter, randomized, controlled study that enrolled a total of 326 participants across 20 clinical trial sites in the United States. Bofanglutide injection and placebo were administered under double-blind conditions, while tirzepatide injection served as an open-label comparator. The study evaluated the efficacy and safety of bofanglutide injection in adult participants who had inadequate weight control despite lifestyle interventions and had either a BMI > 30 kg/m², or a BMI ≥ 27 kg/m² accompanied by weight-related comorbidities (excluding type 2 diabetes). Participants were randomized to receive bofanglutide injection 24 mg, 36 mg, or 48 mg Q2W or placebo, or 15 mg of tirzepatide injection once weekly for 36 weeks (including a dose-escalation phase).
After 36 weeks of treatment, among participants with overweight/obesity without type 2 diabetes, the 48 mg bofanglutide injection group achieved an average weight loss of 15.18%, with no weight loss plateau observed; the 15 mg tirzepatide injection group achieved a mean weight reduction of 16.93%. Bofanglutide injection also demonstrated significant improvements in cardiovascular and metabolic parameters, including blood pressure, waist circumference, and serum uric acid levels. The most common adverse events were gastrointestinal in nature, including nausea, vomiting, and diarrhea; these events were generally mild and transient, and no new safety signals were identified.
|
The above top-line results are based on analyses of the Per-Protocol set (PPS). |
The Insulin Ludefen SUPER-8 study (a head-to-head comparison with insulin icodec) and other studies in the GRADUAL clinical program of bofanglutide injection are currently underway. Detailed results from these two studies are scheduled to be presented at future scientific conferences and published in international academic journals.