Summary: In a phase 3, open-label, active-comparator trial of 440 Chinese adults with type 2 diabetes, the dulaglutide biosimilar LY05008 met its predefined equivalence margin against reference dulaglutide (Trulicity). The mean change in HbA1c at week 24 was -1.44% with LY05008 versus -1.41% with dulaglutide (least-squares mean difference 0.06%, 95% CI -0.08 to 0.19), and safety, pharmacokinetic, and immunogenicity profiles were comparable.
PICO Summary
| Element | Detail |
|---|---|
| Population | 440 Chinese adults with type 2 diabetes mellitus; multicentre, randomised 1:1, open-label phase 3 trial (China). |
| Intervention | Dulaglutide biosimilar LY05008, 1.5 mg subcutaneously once weekly for 24 weeks (n=222). |
| Comparison | Reference dulaglutide (Trulicity), 1.5 mg subcutaneously once weekly for 24 weeks (n=218). |
| Outcome | Primary endpoint, mean change in HbA1c from baseline to week 24: -1.44% (LY05008) vs -1.41% (dulaglutide); least-squares mean difference 0.06%, 95% CI -0.08 to 0.19, p>0.05. The 95% CI fell entirely within the prespecified equivalence margin of -0.4% to 0.4%, so efficacy equivalence was demonstrated. Secondary endpoints were similar between arms: week 24 weight change -2.68 vs -2.42 kg; HbA1c ≤6.5% achieved in 41.0% vs 43.6%. Hypoglycaemic events occurred in 0.9% (LY05008) vs 3.7% (dulaglutide); serious adverse events in 4.1% vs 3.7%. No effect size, ARR, or NNT applies to an equivalence design. |
Expert Commentary
This trial does what a biosimilar confirmatory study is meant to do, and the verdict is that equivalence was met. The least-squares mean difference of 0.06% for HbA1c sits comfortably inside the prespecified -0.4% to 0.4% margin, and the secondary glycaemic, weight, and safety readouts track closely between the two arms. It is worth being precise about what p>0.05 means here: the absence of a significant difference is the desired result in an equivalence framework, not a sign of underpowering, and it should not be read as proof of superiority for either product. The most important caveat is the open-label design, which leaves subjective and behaviour-sensitive outcomes, weight and adverse-event reporting in particular, open to ascertainment bias; a double-blind design would have been more reassuring. Sponsorship by the manufacturer (several authors are affiliated with the company that produces LY05008) is a further reason to weigh the conclusions conservatively, though the tight confidence interval and prespecified margin temper that concern. Can I use this with my patients? For a Chinese adult with type 2 diabetes already suited to once-weekly dulaglutide, an equivalent, potentially lower-cost biosimilar is a reasonable option where it is licensed and available. Regulators and formularies should treat this as supportive evidence and continue routine post-marketing immunogenicity surveillance.
References
Liu L, Cheng Z, Wang L, et al. Efficacy and safety of dulaglutide biosimilar LY05008 versus the reference product dulaglutide (Trulicity) in Chinese adults with type 2 diabetes mellitus: a randomized, open-label, active comparator study. J Diabetes. 2025;17(4):e70077. doi:10.1111/1753-0407.70077
