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Study · Randomized controlled trial · n = 49 · 2022

5 results

A phase I study comparing the pharmacokinetics of the biosimilar (RD12014) with liraglutide (Victoza) in healthy Chinese male subjects.

Zhou R, Guo L, Gao X, Wang Y, Xu W, Zou Y, Li W, Zhuang Y, Liu G, Liu Y

Clinical and translational science31 Jul 2022Cited by 4 (Europe PMC)

PMID35871497 (opens in a new tab)PMCIDPMC9579399 (opens in a new tab)DOI10.1111/cts.13374 (opens in a new tab)PepBankPUB-35871497
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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, the 90% CI of the geometric mean ratio of Cmax for RD12014 to Victoza was within 80.00-125.00%, so the products were bioequivalent for Cmax.

    In plain wordsIn healthy Chinese men, peak blood levels of the biosimilar and Victoza were within the accepted equivalence range.

    Peptide
    Liraglutide
    Outcome
    No significant changeCmax bioequivalence
    Study

    n: not reported in source

    Comparator
    Victoza (reference liraglutide)
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Cmax GMR 90% CI limit
    80 to 125%
    RD12014 vs Victoza

    Source sentences

    Summary
    The 90% CIs of the GMR of RD12014 to Victoza for Cmax and AUC0-last were completely within the range of 80.00-125.00%.
    2 context sentences
    Summary · context
    Eligible subjects were randomized 1:1 to two sequences (RD12014-Victoza or Victoza-RD12014).
    Summary · context
    Subjects received a single 0.6 mg dose of Victoza or RD12014 by abdominal subcutaneous injection during the first period.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese men, the 90% CI of the geometric mean ratio of AUC0-last for RD12014 to Victoza was within 80.00-125.00%, so the products were bioequivalent for AUC.

    In plain wordsIn healthy Chinese men, total blood exposure to the biosimilar and Victoza was within the accepted equivalence range.

    Peptide
    Liraglutide
    Outcome
    No significant changeAUC0-last bioequivalence
    Study

    n: not reported in source

    Comparator
    Victoza (reference liraglutide)
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC0-last GMR 90% CI limit
    80 to 125%
    RD12014 vs Victoza

    Source sentences

    Summary
    The 90% CIs of the GMR of RD12014 to Victoza for Cmax and AUC0-last were completely within the range of 80.00-125.00%.
    2 context sentences
    Summary · context
    Eligible subjects were randomized 1:1 to two sequences (RD12014-Victoza or Victoza-RD12014).
    Summary · context
    Subjects received a single 0.6 mg dose of Victoza or RD12014 by abdominal subcutaneous injection during the first period.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy Chinese men, blood samples of 49 subjects were negative for anti-drug antibody after RD12014 or Victoza.

    In plain wordsIn healthy Chinese men, no antibodies against the drug were found in 49 subjects.

    Peptide
    Liraglutide
    Outcome
    No significant changeAnti-drug antibodies
    Study

    n = 49

    Comparator
    Victoza (reference liraglutide)
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    The blood samples of 49 subjects were negative for anti-drug antibody and the neutralizing antibody was not further detected.
    2 context sentences
    Summary · context
    Eligible subjects were randomized 1:1 to two sequences (RD12014-Victoza or Victoza-RD12014).
    Summary · context
    Subjects received a single 0.6 mg dose of Victoza or RD12014 by abdominal subcutaneous injection during the first period.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy Chinese men, thirteen treatment-related adverse events occurred in 11 subjects (22.4%) after RD12014, similar to Victoza.

    In plain wordsIn healthy Chinese men, side effects after the biosimilar were similar in rate to those after Victoza.

    Peptide
    Liraglutide
    Outcome
    No significant changeTreatment-related adverse events, RD12014
    Study

    n: not reported in source

    Comparator
    Victoza (reference liraglutide)
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Subjects with TRAEs
    22.4%
    RD12014

    Source sentences

    Summary
    Thirteen treatment-related adverse events (TRAEs) were reported in 11 subjects (22.4%) in the RD12014 group, compared to 12 TRAEs reported in 12 subjects (24.5%) in the Victoza group.
    2 context sentences
    Summary · context
    Eligible subjects were randomized 1:1 to two sequences (RD12014-Victoza or Victoza-RD12014).
    Summary · context
    Subjects received a single 0.6 mg dose of Victoza or RD12014 by abdominal subcutaneous injection during the first period.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy Chinese men, 12 treatment-related adverse events occurred in 12 subjects (24.5%) after Victoza, similar to RD12014.

    In plain wordsIn healthy Chinese men, side effects after Victoza were similar in rate to those after the biosimilar.

    Peptide
    Liraglutide
    Outcome
    No significant changeTreatment-related adverse events, Victoza
    Study

    n: not reported in source

    Comparator
    Victoza (reference liraglutide)
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Subjects with TRAEs
    24.5%
    Victoza

    Source sentences

    Summary
    Thirteen treatment-related adverse events (TRAEs) were reported in 11 subjects (22.4%) in the RD12014 group, compared to 12 TRAEs reported in 12 subjects (24.5%) in the Victoza group.
    2 context sentences
    Summary · context
    Eligible subjects were randomized 1:1 to two sequences (RD12014-Victoza or Victoza-RD12014).
    Summary · context
    Subjects received a single 0.6 mg dose of Victoza or RD12014 by abdominal subcutaneous injection during the first period.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT05294536

A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

Sunshine Lake Pharma Co., Ltd.n = 5022 Jun 2020 to 27 Nov 2020

Type 2 Diabetes

Trial pageClinicalTrials.govUpdated 24 Mar 2022

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

    12 Oct 2026, 11:11 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:04 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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