Gan & Lee has reported positive topline trial results for insulin ludefen in type 2 diabetes and the GLP-1 bofanglutide in obesity.
China-based pharmaceutical company Gan & Lee Pharmaceuticals has reported positive topline results for 2 metabolic disease candidates, a once-weekly insulin, ludefen (GZR4), in type 2 diabetes and a glucagon-like peptide-1 (GLP-1) receptor agonist, bofanglutide, in obesity or overweight. The data include a China phase 3 trial of insulin ludefen and China phase 3 and US phase 2 studies of bofanglutide. Full datasets have not yet been presented or peer reviewed.¹
In a company press release, the company stated that the phase 3 trial (SUPER-3) results provide key support for the use of once-weekly basal insulin in intensive treatment settings.¹ The results have clinical relevance because both candidates target areas in which injection burden, durability of glycemic control, weight reduction, and gastrointestinal tolerability remain central treatment considerations.
SUPER-3 was a 26-week, treat-to-target, phase 3 trial conducted at 80 sites in China. It enrolled 596 adults with type 2 diabetes previously treated with basal-bolus insulin, premixed insulin analogs, or dual insulin analogs.¹ Participants received once-weekly insulin ludefen or once-daily insulin glargine U100, each combined with insulin aspart, with or without noninsulin antidiabetic agents.
The trial met its prespecified primary endpoint. Mean hemoglobin A1c (HbA1c) reduction at week 26 was −1.58% with insulin ludefen vs −1.41% with insulin glargine U100, for an estimated between-group difference of −0.17% favoring insulin ludefen (P = .0021).¹ The company also reported higher rates of composite glycemic target attainment, defined as HbA1c less than 7.0% or 6.5% or lower without clinically significant or severe hypoglycemia during the final 12 weeks.
Safety findings were limited, with no severe, level 3 hypoglycemic events occurring in the insulin ludefen group. In comparison, 3 severe events were reported with insulin glargine U100.¹ Detailed rates of level 2 hypoglycemia, nocturnal hypoglycemia, treatment-emergent adverse events, weight change, discontinuations, and insulin dose titration were not provided.
The modest absolute HbA1c difference suggests that clinical significance will depend on the full safety profile, dosing algorithm, adherence data, and patient-reported outcomes. Current diabetes guidance emphasizes individualized glycemic targets, avoidance of hypoglycemia, and simplification of treatment where feasible, particularly for patients requiring injectable therapy.²
The company’s report on GRADUAL-1, a multicenter, randomized, double-blind, placebo-controlled phase 3 study in China, noted that this trial met its primary endpoint.¹ GRADUAL-1 enrolled 640 adults with overweight or obesity and randomized participants to bofanglutide 24 mg, bofanglutide 48 mg, or placebo once every 2 weeks for 52 weeks. Mean baseline body weight was 93.71 kg, and mean body mass index was 33.28.
At week 52, mean body weight reduction was 15.12% with bofanglutide 24 mg and 18.54% with bofanglutide 48 mg vs 1.11% with placebo. At least 5% weight loss was achieved by 91.8% and 98.1% of participants in the 24-mg and 48-mg groups, respectively.¹ The company also reported improvements in waist circumference, blood pressure, triglycerides, and serum uric acid.
In a separate US phase 2 trial, 326 adults with obesity or overweight and weight-related comorbidities, excluding type 2 diabetes, were enrolled across 20 sites.¹ Participants received bofanglutide 24 mg, 36 mg, or 48 mg every 2 weeks, placebo under blinded conditions, or open-label tirzepatide 15 mg once weekly for 36 weeks. Mean weight loss was 15.18% with bofanglutide 48 mg and 16.93% with tirzepatide 15 mg. The company stated that no weight loss plateau was observed in the bofanglutide 48-mg arm.1
Bofanglutide’s adverse event profile was described as consistent with GLP-1 receptor agonists, with gastrointestinal events such as nausea, vomiting, and diarrhea most common and generally mild to moderate or transient.¹ The company’s announcement did not include discontinuation rates, serious adverse events, gallbladder events, pancreatitis signals, or detailed dose-escalation tolerability.
For insulin ludefen, the broader SUPER phase 3 program includes prior China trials in insulin-naive adults and patients previously treated with basal insulin, as well as an ongoing SUPER-8 head-to-head study against insulin icodec.¹ Once-weekly basal insulin development has focused on reducing injection frequency while maintaining glycemic control. Insulin icodec has shown noninferior or superior HbA1c reduction vs daily basal insulin in phase 3 studies, but hypoglycemia and patient selection remain important considerations.3
For both candidates, the main unanswered questions are whether topline efficacy would translate into durable, clinically meaningful benefit, and how safety compares across broader populations. An additional question is whether regulators will view the datasets as sufficient for approval. The company said that detailed results are expected at future scientific meetings and in peer-reviewed publications.¹
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