Summary: In 440 Chinese adults with type 2 diabetes, the once-weekly dulaglutide biosimilar LY05008 was tested for equivalence against reference dulaglutide (Trulicity) over 24 weeks. The mean HbA1c change was -1.44% versus -1.41% (least-squares mean difference 0.06%, 95% CI -0.08 to 0.19), with the confidence interval contained within the prespecified +/-0.4% margin, so analytical and clinical equivalence was demonstrated rather than any added benefit.
PICO Summary
| Element | Detail |
|---|---|
| Population | 440 Chinese adults with type 2 diabetes mellitus; multicentre, randomised (1:1), open-label, active-comparator phase 3 trial conducted in China (ClinicalTrials.gov CTR20221721). |
| Intervention | LY05008, a dulaglutide biosimilar, 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 HbA1c change from baseline to Week 24: -1.44% (LY05008) versus -1.41% (dulaglutide); LSMD 0.06%, 95% CI -0.08 to 0.19, p > 0.05. Equivalence was demonstrated as the 95% CI fell entirely within the prespecified +/-0.4% margin. Secondary endpoints did not differ significantly: HbA1c ≤ 6.5% at Week 24 (41.0% vs 43.6%), weight change at Week 24 (-2.68 vs -2.42 kg), and FPG change at Week 24 (-2.222 vs -2.690 mmol/L). Hypoglycaemia occurred in 0.9% versus 3.7%, and serious adverse events in 4.1% versus 3.7%. No ARR or NNT applies to an equivalence design. |
LY05008 dulaglutide biosimilar vs Trulicity
RCT · type 2 diabetes · 24 weeks
The biosimilar LY05008 was therapeutically equivalent to reference dulaglutide, with the HbA1c difference well inside the prespecified +/-0.4% margin and matching weight and safety profiles over 24 weeks.
Expert Commentary
This was a well-sized phase 3 equivalence trial, and on its own terms it succeeded: the 95% confidence interval for the HbA1c difference sat comfortably within the prespecified +/-0.4% margin, and secondary glycaemic, weight, and safety measures tracked closely between arms. The verdict is that LY05008 behaves like reference dulaglutide across 24 weeks, which is exactly what a biosimilar is required to show, no more and no less. Equivalence is not superiority, and a comparable gastrointestinal and immunogenicity profile should be read as expected rather than reassuring beyond the molecule’s known behaviour. The principal limitation is the open-label design, which can bias subjective endpoints and adherence, though the objective HbA1c primary endpoint is relatively robust to this. Generalisability is also constrained to a Chinese population over a short horizon, with no cardiovascular or durability data. Sponsorship by the manufacturer, with several authors employed by the company that makes LY05008, warrants the usual caution despite the prespecified equivalence margins. Can I use this with my patients? Not yet outside the regions where this product is approved and reimbursed, but for a clinician already prescribing dulaglutide it signals a plausible future lower-cost option once local regulators and real-world safety surveillance catch up. Independent confirmation and longer follow-up would strengthen confidence.
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