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.

Liu L, Cheng Z, Wang L, Zhang L, Li S, Li S, Pang S, Li Q, Bian F, Gu J, Shen J, Fu L and 5 more

Show all authors

Sun B, Zhao Y, Dou C, Zeng Z, Guo L

Journal of diabetes1 Apr 2025Cited by 1 (Europe PMC)

PMID40214296PMCIDPMC11987204DOI10.1111/1753-0407.70077PepBankPUB-40214296

Download PDF PubMedAsk about this study

Jump to 19 results

Summary

BackgroundDulaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been approved for improving glycemic control and reducing the risk of cardiovascular (CV) adverse events. A previous result in healthy Chinese male subjects demonstrated the pharmacokinetic (PK) similarity of LY05008 and the licensed product dulaglutide, with comparable safety and immunogenicity profiles. A well-controlled phase 3 study with an adequate sample size was subsequently conducted for safety and efficacy evaluation.MethodsIn a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks. The primary endpoint was the mean change in HbA1c from baseline to Week 24. The secondary endpoints included the mean change in HbA1c from baseline to Week 12; the proportion of patients who had achieved HbA1c ≤ 6.5% at Weeks 12 and 24; and the mean change in body weight, fasting plasma glucose (FPG) level, and 2-h postprandial plasma glucose (PPG) level from baseline to Weeks 12 and 24. Safety, PK, and immunogenicity profiles were also included for data analysis.ResultsA total of 440 patients were randomized to receive LY05008 (n = 222) or dulaglutide (n = 218). The mean changes in HbA1c from baseline to Week 24 in the LY05008 group and dulaglutide group were -1.44% and -1.41%, respectively, with a least square mean difference (LSMD) and 95% confidence interval (CI) of 0.06% (-0.08, 0.19) (p > 0.05). Efficacy equivalence could be demonstrated since the 95% CI between the reference drug and a biosimilar fell entirely within the range of (-0.4%, 0.4%). The mean changes in HbA1c from baseline to Week 12 in the LY05008 group and dulaglutide group were -1.47% and -1.39% (p > 0.05), respectively. At Week 12, 40.1% of patients who received LY05008 and 42.2% of those who received dulaglutide had a decrease in the HbA1c level to 6.5% or less, and 60.4% and 60.6% of patients in the LY05008 group and the dulaglutide group had a decrease in the HbA1C level < 7%, respectively. At Week 24, 41.0% and 43.6% of patients achieved an HbA1c ≤ 6.5%. 55.9% and 66.5% of patients in the LY05008 group and the dulaglutide group achieved the HbA1c goal of < 7%, respectively. The mean changes in body weight from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.01 and -1.71 kg (p > 0.05) and -2.68 and -2.42 kg (p > 0.05), respectively. The mean changes in FPG level from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.578 and -2.681 mmol/L (p > 0.05) and -2.222 and -2.690 mmol/L, respectively. In the LY05008 group and the dulaglutide group, the mean changes in 2-h PPG levels from baseline to Weeks 12 and 24 were -4.364 and -4.800 mmol/L(p > 0.05) and-3.502 and -4.217 mmol/L (p > 0.05), respectively. The common treatment emergent adverse events (TEAEs) in the LY05008 and dulaglutide groups were decreased appetite, diarrhea, upper respiratory tract infection, hyperuricemia, nausea, urinary tract infection, and vomiting. Most TEAEs were mild to moderate in severity. No significant differences were observed between the groups in terms of TEAEs. Hypoglycemic events were noted in 0.9% of patients who had received LY05008 and in 3.7% of those who had received dulaglutide. Serious adverse events were reported in 4.1% of patients in the LY05008 group and in 3.7% of patients in the dulaglutide group. The PK parameter C_trough and immunogenicity profiles were similar across the two treatment groups.ConclusionThe primary endpoint was met in this study through the demonstration of equivalent efficacy in HbA1c reduction in Chinese adults with T2DM between LY05008 and dulaglutide. Overall, the biosimilar product LY05008 showed comparable safety, PK, and immunogenicity profiles against the reference drug dulaglutide.Trial registrationClinicalTrials.gov identifier: CTR20221721.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study19

19 results from studies that gave the peptide. 19 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, reference dulaglutide and LY05008 produced equivalent HbA1c reductions at Week 24.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar produced similar blood sugar reductions at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeHbA1c change at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
HbA1c change
−1.41%
reference dulaglutide at Week 24
HbA1c change
−1.44%
LY05008 at Week 24
Least square mean difference in HbA1c change, LY05008 minus dulaglutide
0.06%
Week 24; 95% CI -0.08 to 0.19; p > 0.05
Source sentences
Summary
The mean changes in HbA1c from baseline to Week 24 in the LY05008 group and dulaglutide group were -1.44% and -1.41%, respectively, with a least square mean difference (LSMD) and 95% confidence interval (CI) of 0.06% (-0.08, 0.19) (p > 0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
Efficacy equivalence could be demonstrated since the 95% CI between the reference drug and a biosimilar fell entirely within the range of (-0.4%, 0.4%).
Summary · context
The primary endpoint was the mean change in HbA1c from baseline to Week 24.
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429601
02HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, HbA1c reductions at Week 12 did not differ significantly between reference dulaglutide and LY05008.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in blood sugar reduction at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeHbA1c change at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
HbA1c change
−1.39%
reference dulaglutide
HbA1c change
−1.47%
LY05008
Source sentences
Summary
The mean changes in HbA1c from baseline to Week 12 in the LY05008 group and dulaglutide group were -1.47% and -1.39% (p > 0.05), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429602
03HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, 42.2% on reference dulaglutide versus 40.1% on LY05008 achieved HbA1c at most 6.5% at Week 12.
In plain wordsIn adults with diabetes, 42.2% on dulaglutide versus 40.1% on its biosimilar met the lower blood sugar target at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedHbA1c at most 6.5% at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Responders
42.2%
reference dulaglutide; HbA1c at most 6.5% at Week 12
Responders
40.1%
LY05008; HbA1c at most 6.5% at Week 12
Source sentences
Summary
At Week 12, 40.1% of patients who received LY05008 and 42.2% of those who received dulaglutide had a decrease in the HbA1c level to 6.5% or less, and 60.4% and 60.6% of patients in the LY05008 group and the dulaglutide group had a decrease in the HbA1C level < 7%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429603
04HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, 43.6% on reference dulaglutide versus 41.0% on LY05008 achieved HbA1c at most 6.5% at Week 24.
In plain wordsIn adults with diabetes, 43.6% on dulaglutide versus 41.0% on its biosimilar met the lower blood sugar target at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedHbA1c at most 6.5% at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Responders (HbA1c at most 6.5%)
43.6%
reference dulaglutide; Week 24
Responders (HbA1c at most 6.5%)
41%
LY05008; Week 24
Source sentences
Summary
At Week 24, 41.0% and 43.6% of patients achieved an HbA1c ≤ 6.5%.
2 context sentences(design, population, supporting numbers)
Summary · context
A total of 440 patients were randomized to receive LY05008 (n = 222) or dulaglutide (n = 218).
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429605
05HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, weight changes were -1.71 kg with reference dulaglutide and -2.01 kg with LY05008, without significant difference.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in weight reduction at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeBody weight change at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Body weight change
−1.71 kg
reference dulaglutide; Week 12
Body weight change
−2.01 kg
LY05008; Week 12
Source sentences
Summary
The mean changes in body weight from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.01 and -1.71 kg (p > 0.05) and -2.68 and -2.42 kg (p > 0.05), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429607
06HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, weight changes were -2.42 kg with reference dulaglutide and -2.68 kg with LY05008, without significant difference.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in weight reduction at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeBody weight change at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Body weight change
−2.42 kg
reference dulaglutide; Week 24
Body weight change
−2.68 kg
LY05008; Week 24
Source sentences
Summary
The mean changes in body weight from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.01 and -1.71 kg (p > 0.05) and -2.68 and -2.42 kg (p > 0.05), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429608
07HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, fasting glucose changes were -2.681 mmol/L with reference dulaglutide and -2.578 mmol/L with LY05008, without significant difference.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in fasting glucose reduction at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeFasting plasma glucose at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Fasting plasma glucose change
−2.681 mmol/L
reference dulaglutide; Week 12
Fasting plasma glucose change
−2.578 mmol/L
LY05008; Week 12
Source sentences
Summary
The mean changes in FPG level from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.578 and -2.681 mmol/L (p > 0.05) and -2.222 and -2.690 mmol/L, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429609
08HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, fasting glucose changed by -2.690 mmol/L with reference dulaglutide versus -2.222 mmol/L with LY05008 at Week 24.
In plain wordsIn adults with diabetes, fasting glucose fell numerically more with dulaglutide than its biosimilar at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedFasting plasma glucose at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Fasting plasma glucose change
−2.69 mmol/L
reference dulaglutide; Week 24
Fasting plasma glucose change
−2.222 mmol/L
LY05008; Week 24
Source sentences
Summary
The mean changes in FPG level from baseline to Weeks 12 and 24 in the LY05008 group and dulaglutide group were -2.578 and -2.681 mmol/L (p > 0.05) and -2.222 and -2.690 mmol/L, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429610
09HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, postprandial glucose changes were -4.800 mmol/L with reference dulaglutide and -4.364 mmol/L with LY05008, without significant difference.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in post-meal glucose reduction at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changePostprandial glucose at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
2-h postprandial glucose change
−4.8 mmol/L
reference dulaglutide; Week 12
2-h postprandial glucose change
−4.364 mmol/L
LY05008; Week 12
Source sentences
Summary
In the LY05008 group and the dulaglutide group, the mean changes in 2-h PPG levels from baseline to Weeks 12 and 24 were -4.364 and -4.800 mmol/L(p > 0.05) and-3.502 and -4.217 mmol/L (p > 0.05), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429611
10HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, postprandial glucose changes were -4.217 mmol/L with reference dulaglutide and -3.502 mmol/L with LY05008, without significant difference.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar showed no significant difference in post-meal glucose reduction at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changePostprandial glucose at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
2-h postprandial glucose change
−4.217 mmol/L
reference dulaglutide; Week 24
2-h postprandial glucose change
−3.502 mmol/L
LY05008; Week 24
Source sentences
Summary
In the LY05008 group and the dulaglutide group, the mean changes in 2-h PPG levels from baseline to Weeks 12 and 24 were -4.364 and -4.800 mmol/L(p > 0.05) and-3.502 and -4.217 mmol/L (p > 0.05), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429612
11HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, 60.6% on reference dulaglutide versus 60.4% on LY05008 achieved HbA1c below 7% at Week 12.
In plain wordsIn adults with diabetes, 60.6% on dulaglutide versus 60.4% on its biosimilar reached HbA1c below 7% at Week 12.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedHbA1c below 7% at week 12
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 12 weeksAs given in this study (human).
Measurements
Responders (HbA1c below 7%)
60.6%
reference dulaglutide; Week 12
Responders (HbA1c below 7%)
60.4%
LY05008; Week 12
Source sentences
Summary
At Week 12, 40.1% of patients who received LY05008 and 42.2% of those who received dulaglutide had a decrease in the HbA1c level to 6.5% or less, and 60.4% and 60.6% of patients in the LY05008 group and the dulaglutide group had a decrease in the HbA1C level < 7%, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429604
12HumanRandomized controlled trialEfficacy outcome
In Chinese adults with type 2 diabetes, 66.5% on reference dulaglutide versus 55.9% on LY05008 achieved HbA1c below 7% at Week 24.
In plain wordsIn adults with diabetes, 66.5% on dulaglutide versus 55.9% on its biosimilar reached HbA1c below 7% at Week 24.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedHbA1c below 7% at week 24
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Responders (HbA1c below 7%)
66.5%
reference dulaglutide; Week 24
Responders (HbA1c below 7%)
55.9%
LY05008; Week 24
Source sentences
Summary
55.9% and 66.5% of patients in the LY05008 group and the dulaglutide group achieved the HbA1c goal of < 7%, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
At Week 24, 41.0% and 43.6% of patients achieved an HbA1c ≤ 6.5%.
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429606
13HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, the common treatment-emergent adverse events in both the reference dulaglutide and LY05008 groups were decreased appetite, diarrhea, upper respiratory tract infection, hyperuricemia, nausea, urinary tract infection and vomiting.
In plain wordsIn adults with diabetes, common side effects in both groups included reduced appetite, diarrhea, nausea, vomiting, high uric acid and infections.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedCommon treatment-emergent adverse events
Study
n = 440
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
The common treatment emergent adverse events (TEAEs) in the LY05008 and dulaglutide groups were decreased appetite, diarrhea, upper respiratory tract infection, hyperuricemia, nausea, urinary tract infection, and vomiting.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429613
14HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, most treatment-emergent adverse events during dulaglutide product treatment were mild to moderate.
In plain wordsIn adults with diabetes, most adverse events during dulaglutide product treatment were mild to moderate.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicableAdverse event severity
Study
n = 440
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
Most TEAEs were mild to moderate in severity.
2 context sentences(design, population, supporting numbers)
Summary · context
The common treatment emergent adverse events (TEAEs) in the LY05008 and dulaglutide groups were decreased appetite, diarrhea, upper respiratory tract infection, hyperuricemia, nausea, urinary tract infection, and vomiting.
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429620
15HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, treatment-emergent adverse events did not differ significantly between reference dulaglutide and LY05008.
In plain wordsIn adults with diabetes, adverse events did not differ significantly between dulaglutide and its biosimilar.
Peptide
Dulaglutide (Trulicity)
Outcome
No significant changeTreatment-emergent adverse events
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
No significant differences were observed between the groups in terms of TEAEs.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429621
16HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, hypoglycemic events occurred in 3.7% on reference dulaglutide versus 0.9% on LY05008.
In plain wordsIn adults with diabetes, low blood sugar occurred in 3.7% on dulaglutide versus 0.9% on its biosimilar.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedHypoglycemic events
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Hypoglycemic events
3.7%
reference dulaglutide
Hypoglycemic events
0.9%
LY05008
Source sentences
Summary
Hypoglycemic events were noted in 0.9% of patients who had received LY05008 and in 3.7% of those who had received dulaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429622
17HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, serious adverse events occurred in 3.7% on reference dulaglutide versus 4.1% on LY05008.
In plain wordsIn adults with diabetes, serious adverse events occurred in 3.7% on dulaglutide versus 4.1% on its biosimilar.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedSerious adverse events
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Adverse events · Whole body
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Serious adverse events
3.7%
reference dulaglutide
Serious adverse events
4.1%
LY05008
Source sentences
Summary
Serious adverse events were reported in 4.1% of patients in the LY05008 group and in 3.7% of patients in the dulaglutide group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429623
18HumanRandomized controlled trialPharmacokinetics
In Chinese adults with type 2 diabetes, trough concentrations were similar between reference dulaglutide and LY05008.
In plain wordsIn adults with diabetes, dulaglutide and its biosimilar had similar trough drug concentrations.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedTrough concentration
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
The PK parameter C_trough and immunogenicity profiles were similar across the two treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429624
19HumanRandomized controlled trialSafety outcome
In Chinese adults with type 2 diabetes, immunogenicity profiles were similar between reference dulaglutide and LY05008.
In plain wordsIn adults with diabetes, immune reactions were similar with dulaglutide and its biosimilar.
Peptide
Dulaglutide (Trulicity)
Outcome
Direction not reportedImmunogenicity
Study
n = 440
Comparator
LY05008 dulaglutide biosimilar
Outcome group
Immune response · Immune and inflammation
Studied dose
1.5 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).
Source sentences
Summary
The PK parameter C_trough and immunogenicity profiles were similar across the two treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
In a multicenter, randomized, open-label, active comparator phase 3 study, Chinese adults diagnosed with type 2 diabetes mellitus (T2DM) were randomly assigned 1:1 to receive a subcutaneous injection of 1.5 mg LY05008 or dulaglutide once weekly for 24 weeks.
Show in the study text Report a problemFND-4021429625

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.

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.

Summary

Results from this study19

Version history

Subjects

Publication types

MeSH terms

Keywords