Dulaglutide Biosimilar LY05008 Shows Efficacy and Safety in Treating Type 2 Diabetes

The biosimilar LY05008 demonstrated equivalent efficacy to dulaglutide in reducing hemoglobin A1c (HbA1c) levels, with comparable safety, pharmacokinetic, and immunogenicity profiles in Chinese adults with type 2 diabetes, according to a study published in the Journal of Diabetes.1

Several Chinese companies are developing biosimilars for dulaglutide, a weekly GLP-1 receptor agonist approved for type 2 diabetes.2 Boan Biotech's dulaglutide biosimilar (BA5101) has demonstrated effectiveness in controlling blood glucose and HbA1C.3 It also helps manage cardiovascular risk factors, such as weight gain and hyperlipidemia, with a lower risk of hypoglycemia.

Researchers conducted a phase 3 clinical trial to confirm that LY05008 biosimilar is therapeutically equivalent to the original dulaglutide by comparing the 2 products' efficacy, safety, pharmacokinetics, and immunogenicity in Chinese adults with type 2 diabetes whose condition is not adequately managed by metformin alone.1

The study screened 536 patients with type 2 diabetes, with 440 ultimately enrolled and randomized into either the LY05008 group (n = 222 patients) or the dulaglutide group (n = 218 patients). Both groups received a weekly subcutaneous injection of 1.5 mg. The per-protocol set included 95.5% of all patients, with similar percentages in each treatment group.

The majority of participants were Chinese men (59.1%). The average age, weight, and BMI were comparable between both groups. For example, the LY05008 group had a mean age of 52.9 years, while the dulaglutide group had a mean age of 52 years.

Additionally, the baseline HbA1c levels were similar across both groups, with about 56% of patients having an HbA1c level below 8.5% and the remaining having an HbA1c level of 8.5% or higher. Overall, no significant differences in baseline characteristics were observed between the 2 groups.

At week 24, the mean HbA1c reduction from baseline was –1.44% for the LY05008 group and –1.41% for the dulaglutide group. The difference in the least square mean change between the 2 groups was 0.06%, falling within the -0.4% to 0.4% equivalence margin. These results confirm that there was no statistically significant difference in clinical efficacy between LY05008 and dulaglutide (P > .05).

After 12 weeks, both the LY05008 and dulaglutide groups showed significant reductions in average HbA1c levels, with mean changes of −1.47% and −1.39%, respectively. The difference between the 2 groups was not statistically significant. At this time point, a similar percentage of patients in both groups achieved the HbA1c goals of 6.5% or less (40.1% for LY05008 vs 42.2% for dulaglutide) and less than 7% (60.4% vs 60.6%).

By week 24, the results remained comparable. The percentage of patients reaching the HbA1c goal of 6.5% or less was 41% for the LY05008 group and 43.6% for the dulaglutide group. Additionally, 55.9% of patients on LY05008 and 66.5% on dulaglutide achieved an HbA1c level below 7%.

Both LY05008 and dulaglutide showed a significant reduction in fasting plasma glucose (FPG) levels. At week 12, the FPG reduction was comparable between the 2 groups. However, at week 24, dulaglutide demonstrated a slightly greater reduction. For postprandial glucose (2-hour PPG), both treatments reduced levels, with no significant difference between the 2 groups at either week 12 or week 24.

Regarding weight loss, both groups experienced similar reductions. At week 12, patients on LY05008 lost an average of 2.01 kg, while those on dulaglutide lost 1.71 kg. By week 24, the weight loss was 2.68 kg for the LY05008 group and 2.42 kg for the dulaglutide group.

Overall, the safety profiles of LY05008 and dulaglutide were comparable. In the LY05008 group, 91% of patients experienced at least 1 treatment-emergent adverse event (TEAE), compared with 89.9% in the dulaglutide group. The number of TEAEs related to the study drug was similar between both groups: 57.7% for LY05008 and 61.5% for dulaglutide.

The most common side effects, occurring in at least 10% of patients, were also similar for both drugs. These included decreased appetite, diarrhea, nausea, and vomiting. Hypoglycemia occurred less frequently in the LY05008 group (0.9%) than in the dulaglutide group (3.7%). The rate of serious adverse events was also similar between the 2 groups, at 4.1% and 3.7%, respectively.

Trough plasma concentrations at steady state were comparable between the LY05008 and dulaglutide groups. Only 1 patient, who was in the LY05008 group, tested positive for neutralizing antibodies. All other patients with positive antidrug antibodies in both groups tested negative.

“In Chinese patients with T2DM [type 2 diabetes mellitus] following multiple subcutaneous injections, efficacy equivalence was achieved between LY05008 and dulaglutide with respect to change from baseline in HbA1C reduction to week 24,” study authors concluded.

References

1. 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. Journal of Diabetes. 2025;17(4). doi:10.1111/1753-0407.70077
2. Jeremias S. Phase 1 study shows promise for dulaglutide biosimilar. The Center for Biosimilars®. July 25, 2024. Accessed August 6, 2025. https://www.centerforbiosimilars.com/view/phase-1-study-shows-promise-for-dulaglutide-biosimilar
3. Boan Biotech announces publication of phase 1 clinical study results of BA5101 in the Journal of Expert Opinion on Biological Therapy. News release. Boan Biotech. March 15, 2023. Accessed August 6, 2025. https://www.boan-bio.com/en/info.php?id=197