CSPC Pharmaceutical Group Limited (CSPC Pharma) has disclosed favourable Phase III data for Efmedaglutide Alfa Injection (TG103), a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, combined with metformin in Chinese adults with type 2 diabetes mellitus (T2DM). The findings were presented during a short oral discussion at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026).
The multicentre, randomised, open-label study enrolled 632 adults (18–75 years) whose glycated haemoglobin (HbA1c) remained between 7.0 % and 10.5 % despite at least 1,500 mg/day of metformin for eight weeks. Participants were randomised to once-weekly TG103 7.5 mg (n = 210), TG103 15 mg following a four-week uptitration (n = 211), or dulaglutide 1.5 mg (n = 211) for 28 weeks. After Week 28, the 7.5 mg TG103 cohort escalated to 15 mg, while the other regimens continued unchanged to Week 52.
Efficacy data show both TG103 doses delivered clinically meaningful HbA1c reductions at Week 28, with the 15 mg arm achieving a 1.38 % decrease from baseline. Under the treatment-policy strategy analysis, both TG103 groups were non-inferior to dulaglutide. A rapid onset was observed as early as Week 4, and ≥1 % HbA1c reductions were recorded by Week 8. At Week 52, the 15 mg TG103 group sustained a 1.31 % HbA1c decline versus 1.25 % for dulaglutide; the 7.5 mg/15 mg sequence was comparable to the comparator. The proportion of patients reaching HbA1c ≤7.0 % was higher for TG103 15 mg than for dulaglutide at both Week 28 (53.9 % vs 52.2 %) and Week 52 (52.2 % vs 46.8 %).
Safety profiles were similar across treatment arms. Gastrointestinal events were the most common adverse events and occurred at comparable rates. Incidence of hypoglycaemia and treatment discontinuations was low, and no severe hypoglycaemic episodes were reported.
Investigators concluded that TG103 provides rapid, durable glycaemic control with a favourable safety and tolerability profile under a straightforward dose-escalation scheme. As a recombinant human GLP-1 Fc fusion protein, TG103 selectively activates GLP-1 receptors, enhancing insulin secretion, suppressing glucagon, reducing appetite, and offering potential cardiovascular and metabolic benefits.