On the evening of November 11, BrightGene reported that BGM0504, an injectable dual GLP-1 and GIP receptor agonist developed by its Suzhou subsidiary, met the objectives of two Phase III trials. The monotherapy and combination trials both used change from baseline in HbA1c at week 32 as the primary endpoint.
The monotherapy trial enrolled 227 Chinese adults with type 2 diabetes whose blood glucose remained inadequately controlled after diet and exercise interventions. At week 32, mean HbA1c fell by 2.20 and 2.60 percentage points with 5 mg and 10 mg, respectively, versus 0.51 points with placebo. Both doses were statistically superior to placebo.
The combination trial enrolled 553 Chinese adults whose blood glucose remained inadequately controlled on metformin alone or with a sulfonylurea. The comparator was semaglutide 1.0 mg once weekly. At week 32, mean HbA1c fell by 2.41 percentage points with BGM0504 10 mg and 1.95 points with semaglutide. The 10 mg dose was statistically superior, and the 5 mg dose was noninferior. At week 52, 10 mg remained statistically superior, and 5 mg also showed statistical superiority in a supplementary analysis.
Most common gastrointestinal adverse reactions were transient and mild to moderate. No severe hypoglycemia was reported in the BGM0504 arms during 52 weeks of treatment in either trial. The company said its Chinese marketing application for weight management was under review and it would continue pursuing a filing for glycemic control.

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