Chinese pharmaceutical company Gan & Lee Pharmaceuticals (SH:603087) announced on Saturday that it presented multiple Phase 2 clinical study results of ultra-long-acting GLP-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection and once-weekly basal insulin analogue GZR4 injection during a poster presentation at the 85th Scientific Sessions of the American Diabetes Association (ADA).

In a Phase 2a clinical trial of bofanglutide injection, 36 adults with Type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control through diet and exercise and/or irregular use of antidiabetic medications were randomised to receive either bofanglutide injection (N=27) or placebo (N=9) once weekly (QW) for 23 weeks, with the dose escalating from 1.5 mg to 13 mg. The key efficacy endpoint was HbA1c change from baseline to week 23.

After 23 weeks of treatment, the mean HbA1c change from baseline in the bofanglutide groups was -1.81% compared to 0.12% in the placebo group, with an estimated treatment difference of -1.93 percentage points. The company says that bofanglutide showed comprehensive improvements over placebo in multiple metabolic parameters, including fasting plasma glucose (FPG), glycated albumin (GA), waist circumference (WC), blood pressure, and lipid profiles. In terms of safety, bofanglutide was well tolerated in patients with T2DM. No hypoglycaemic events or investigational product-related serious adverse events were reported during the study.

The Phase 2 clinical study of GZR4 injection enrolled a total of 83 Chinese patients with T2DM who had inadequate glycaemic control on oral antidiabetic drugs (OADs) (Part A), and 96 patients with inadequate control on OADs combined with basal insulin therapy (Part B). Participants were randomised to receive QW GZR4 injection (Part A: N=42; Part B: N=41) or once-daily IDeg (Tresiba) injection (Part A: N=48; Part B: N=48) for 16 weeks of treatment. The primary efficacy endpoint was the change in HbA1c from baseline to week 16.

After 16 weeks of treatment, in patients from Part A, the mean change in HbA1c was comparable between GZR4 groups and IDeg groups (-1.50% versus -1.48%, p = 0.90). The proportion of participants achieving HbA1c target of