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Study · Randomized controlled trial · n = 82 · 2023

6 results

Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects.

Zhang Q, Sun C, Wu J, Wu J, Zhang X, Liu Y, Dou C, Qin H, Zhang Q, Zhou R, Hu W

Expert opinion on biological therapy13 Mar 2023Cited by 1 (Europe PMC)

PMID36880118 (opens in a new tab)DOI10.1080/14712598.2023.2189009 (opens in a new tab)PepBankPUB-36880118
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, dulaglutide and LY05008 met bioequivalence limits for AUC to infinity.

    In plain wordsIn healthy Chinese men, dulaglutide and LY05008 had equivalent total drug exposure.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableAUC to infinity
    Study

    n = 82

    Comparator
    LY05008
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0 - ∞, AUC0-t and Cmax of LY05008 to dulaglutide were all within the bioequivalence limits of 80%-125%.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, dulaglutide and LY05008 met bioequivalence limits for AUC to the last quantifiable concentration.

    In plain wordsIn healthy Chinese men, dulaglutide and LY05008 had equivalent exposure through the last measurable concentration.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableAUC to last quantifiable concentration
    Study

    n = 82

    Comparator
    LY05008
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0 - ∞, AUC0-t and Cmax of LY05008 to dulaglutide were all within the bioequivalence limits of 80%-125%.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, dulaglutide and LY05008 met bioequivalence limits for maximum serum concentration.

    In plain wordsIn healthy Chinese men, dulaglutide and LY05008 had equivalent peak concentrations.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    Not applicableMaximum serum concentration
    Study

    n = 82

    Comparator
    LY05008
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0 - ∞, AUC0-t and Cmax of LY05008 to dulaglutide were all within the bioequivalence limits of 80%-125%.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, other pharmacokinetic parameters were comparable between dulaglutide and LY05008.

    In plain wordsIn healthy Chinese men, other drug movement measures were similar for dulaglutide and LY05008.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeOther pharmacokinetic parameters
    Study

    n = 82

    Comparator
    LY05008
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Other PK parameters, safety, and immunogenicity profiles were comparable across the two treatment groups.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy Chinese men, safety profiles were comparable between dulaglutide and LY05008.

    In plain wordsIn healthy Chinese men, dulaglutide and LY05008 had similar safety profiles.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeSafety profile
    Study

    n = 82

    Comparator
    LY05008
    Outcome group
    Adverse events · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Other PK parameters, safety, and immunogenicity profiles were comparable across the two treatment groups.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.
  6. 06HumanRandomized controlled trialSafety outcome

    In healthy Chinese men, immunogenicity profiles were comparable between dulaglutide and LY05008.

    In plain wordsIn healthy Chinese men, dulaglutide and LY05008 caused similar immune responses to treatment.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeImmunogenicity
    Study

    n = 82

    Comparator
    LY05008
    Outcome group
    Immune response · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Other PK parameters, safety, and immunogenicity profiles were comparable across the two treatment groups.
    1 context sentence
    Summary · context
    In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously.

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.

  1. Version 2Current

    22 Oct 2026, 02:25 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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