Study wrapper · #300
Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial.
Editor's note
A Phase 2b, randomised, open-label, active-controlled trial (n=272, 37 Chinese sites, 24 weeks) in which semaglutide 1 mg weekly served as the reference arm against a novel GLP-1 receptor agonist, bofanglutide, at several doses and schedules. At 24 weeks, bofanglutide lowered HbA1c by 1.87–2.32%, and the higher-dose arms (18 mg every two weeks and 24 mg weekly) showed statistically greater reductions than semaglutide 1 mg (differences about −0.68% and −0.72%). Importantly, the comparator was semaglutide 1 mg, not its higher 2 mg dose, so this does not establish superiority over maximal semaglutide. Gastrointestinal adverse events were more common with bofanglutide (82–87%) than semaglutide (52%), though mostly grade 1–2; no severe hypoglycaemia occurred. Limits the authors note: open-label design, short 24-week duration, and a Chinese-only population. A solid early-phase signal for bofanglutide; semaglutide's own large Phase 3 evidence base is unaffected by its role as comparator here.
Plain-language abstract
This was a mid-stage (Phase 2b) clinical trial testing a new diabetes drug called bofanglutide against semaglutide, a well-established GLP-1 medicine used as the comparison. Researchers enrolled 272 adults with type 2 diabetes at 37 sites in China and randomly assigned them to one of five groups: bofanglutide at various doses given weekly or every two weeks, or semaglutide 1 mg weekly. Everyone knew which drug they received (open-label). After 24 weeks, all bofanglutide doses lowered the blood-sugar marker HbA1c by about 1.9% to 2.3%. The higher bofanglutide doses lowered it more than semaglutide 1 mg did, by roughly 0.7 percentage points. Stomach and gut side effects — mostly mild to moderate — were more common with bofanglutide (about 82–87% of people) than with semaglutide (about 52%). Low blood sugar was rare and never severe. The authors note the study was short, unblinded, compared against the lower 1 mg semaglutide dose rather than the maximum dose, and included only Chinese participants, so the results are an early signal that will need larger, longer trials.