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Study · Animal study (in vivo) · mouse and rat · 2015

13 results

Chronic Toxicity and Carcinogenicity Studies of the Long-Acting GLP-1 Receptor Agonist Dulaglutide in Rodents.

Byrd RA, Sorden SD, Ryan T, Pienkowski T, LaRock R, Quander R, Wijsman JA, Smith HW, Blackbourne JL, Rosol TJ, Long GG, Martin JA, Vahle JL

Endocrinology10 Apr 2015Cited by 23 (Europe PMC)

PMID25860029 (opens in a new tab)DOI10.1210/en.2014-1722 (opens in a new tab)PepBankPUB-25860029
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 study13

13 results from studies that gave the peptide. No result from this study comes from people.

  1. 01AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide statistically increased diffuse thyroid C-cell hyperplasia in rats at 0.5 mg/kg or greater.

    In plain wordsIn rats, dulaglutide increased widespread thyroid C-cell overgrowth at 0.5 mg/kg or greater compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseDiffuse C-cell hyperplasia
    Study

    ratn: not reported in source

    Rat carcinogenicity study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.5 mg/kg or greater twice weekly · subcutaneous · 93 weeksAs given in this study (rat).

    Source sentences

    Summary
    In rats, diffuse C-cell hyperplasia and adenomas were statistically increased at 0.5 mg/kg or greater (P ≤ .01 at 5 mg/kg), and C-cell carcinomas were numerically increased at 5 mg/kg.
    1 context sentence
    Summary · context
    Rats were injected sc twice weekly for 93 weeks with dulaglutide 0, 0.05, 0.5, 1.5, or 5 mg/kg corresponding to 0, 0.5, 7, 20, and 58 times, respectively, the maximum recommended human dose based on plasma area under the curve.
  2. 02AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide statistically increased thyroid C-cell adenomas in rats at 0.5 mg/kg or greater.

    In plain wordsIn rats, dulaglutide increased benign thyroid C-cell tumors at 0.5 mg/kg or greater compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseC-cell adenomas
    Study

    ratn: not reported in source

    Rat carcinogenicity study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.5 mg/kg or greater twice weekly · subcutaneous · 93 weeksAs given in this study (rat).

    Source sentences

    Summary
    In rats, diffuse C-cell hyperplasia and adenomas were statistically increased at 0.5 mg/kg or greater (P ≤ .01 at 5 mg/kg), and C-cell carcinomas were numerically increased at 5 mg/kg.
    1 context sentence
    Summary · context
    Rats were injected sc twice weekly for 93 weeks with dulaglutide 0, 0.05, 0.5, 1.5, or 5 mg/kg corresponding to 0, 0.5, 7, 20, and 58 times, respectively, the maximum recommended human dose based on plasma area under the curve.
  3. 03AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide numerically increased thyroid C-cell carcinomas in rats at 5 mg/kg.

    In plain wordsIn rats, thyroid C-cell cancers were numerically more frequent with dulaglutide 5 mg/kg than controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseC-cell carcinomas
    Study

    ratn: not reported in source

    Rat carcinogenicity study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 93 weeksAs given in this study (rat).

    Source sentences

    Summary
    In rats, diffuse C-cell hyperplasia and adenomas were statistically increased at 0.5 mg/kg or greater (P ≤ .01 at 5 mg/kg), and C-cell carcinomas were numerically increased at 5 mg/kg.
    1 context sentence
    Summary · context
    Rats were injected sc twice weekly for 93 weeks with dulaglutide 0, 0.05, 0.5, 1.5, or 5 mg/kg corresponding to 0, 0.5, 7, 20, and 58 times, respectively, the maximum recommended human dose based on plasma area under the curve.
  4. 04AnimalAnimal study (in vivo)Safety outcome

    Focal C-cell hyperplasia was higher than controls in female rats receiving dulaglutide 0.5, 1.5, and 5 mg/kg.

    In plain wordsIn female rats, dulaglutide increased localized thyroid C-cell overgrowth compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseFocal C-cell hyperplasia
    Study

    ratn: not reported in source

    Female rats
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.5, 1.5, and 5 mg/kg twice weekly · subcutaneous · 93 weeksAs given in this study (rat).

    Source sentences

    Summary
    Focal C-cell hyperplasia was higher compared with controls in females given 0.5, 1.5, and 5 mg/kg.
    1 context sentence
    Summary · context
    Rats were injected sc twice weekly for 93 weeks with dulaglutide 0, 0.05, 0.5, 1.5, or 5 mg/kg corresponding to 0, 0.5, 7, 20, and 58 times, respectively, the maximum recommended human dose based on plasma area under the curve.
  5. 05AnimalAnimal study (in vivo)Safety outcome

    No dulaglutide-related thyroid C-cell hyperplasia occurred in transgenic mice at any tested dose.

    In plain wordsIn transgenic mice, dulaglutide did not cause thyroid C-cell overgrowth compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeC-cell hyperplasia
    Study

    mousen: not reported in source

    Transgenic mice
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.3, 1, or 3 mg/kg twice weekly · subcutaneous · 26 weeksAs given in this study (mouse).

    Source sentences

    Summary
    In transgenic mice, no dulaglutide-related C-cell hyperplasia or neoplasia was observed at any dose; however, minimal cytoplasmic hypertrophy of C cells was observed in all dulaglutide groups.
    1 context sentence
    Summary · context
    Transgenic mice were dosed sc twice weekly with dulaglutide 0, 0.3, 1, or 3 mg/kg for 26 weeks.
  6. 06AnimalAnimal study (in vivo)Safety outcome

    No dulaglutide-related thyroid C-cell neoplasia occurred in transgenic mice at any tested dose.

    In plain wordsIn transgenic mice, dulaglutide did not cause thyroid C-cell tumors compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeC-cell neoplasia
    Study

    mousen: not reported in source

    Transgenic mice
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.3, 1, or 3 mg/kg twice weekly · subcutaneous · 26 weeksAs given in this study (mouse).

    Source sentences

    Summary
    In transgenic mice, no dulaglutide-related C-cell hyperplasia or neoplasia was observed at any dose; however, minimal cytoplasmic hypertrophy of C cells was observed in all dulaglutide groups.
    1 context sentence
    Summary · context
    Transgenic mice were dosed sc twice weekly with dulaglutide 0, 0.3, 1, or 3 mg/kg for 26 weeks.
  7. 07AnimalAnimal study (in vivo)Safety outcome

    Minimal thyroid C-cell cytoplasmic hypertrophy occurred in all dulaglutide groups in transgenic mice.

    In plain wordsIn transgenic mice, all dulaglutide groups showed minimal enlargement of thyroid C-cell cytoplasm.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseC-cell cytoplasmic hypertrophy
    Study

    mousen: not reported in source

    Transgenic mice
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    0.3, 1, or 3 mg/kg twice weekly · subcutaneous · 26 weeksAs given in this study (mouse).

    Source sentences

    Summary
    In transgenic mice, no dulaglutide-related C-cell hyperplasia or neoplasia was observed at any dose; however, minimal cytoplasmic hypertrophy of C cells was observed in all dulaglutide groups.
    1 context sentence
    Summary · context
    Transgenic mice were dosed sc twice weekly with dulaglutide 0, 0.3, 1, or 3 mg/kg for 26 weeks.
  8. 08AnimalAnimal study (in vivo)Pharmacokinetics

    Dulaglutide systemic exposures decreased over time in mice, possibly because of an antidrug antibody response.

    In plain wordsIn mice, dulaglutide exposure decreased over time, possibly because of antibodies against the drug.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    DecreaseSystemic exposure over time
    Study

    mousen: not reported in source

    Transgenic mice
    Comparator
    Earlier exposure
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (mouse).

    Source sentences

    Summary
    Systemic exposures decreased over time in mice, possibly due to an antidrug antibody response.
    1 context sentence
    Summary · context
    Transgenic mice were dosed sc twice weekly with dulaglutide 0, 0.3, 1, or 3 mg/kg for 26 weeks.
  9. 09AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide increased focal thyroid C-cell hyperplasia in the rat C-cell mass study.

    In plain wordsIn rats, dulaglutide increased localized thyroid C-cell overgrowth compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    IncreaseFocal C-cell hyperplasia
    Study

    ratn: not reported in source

    Rat C-cell mass study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 52 weeksAs given in this study (rat).

    Source sentences

    Summary
    Dulaglutide increased focal C-cell hyperplasia; however, quantitative increases in C-cell mass did not occur.
    1 context sentence
    Summary · context
    In a 52-week study designed to quantitate C-cell mass and plasma calcitonin responses, rats received twice-weekly sc injections of dulaglutide 0 or 5 mg/kg.
  10. 10AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide did not quantitatively increase thyroid C-cell mass in the rat C-cell mass study.

    In plain wordsIn rats, dulaglutide did not increase measured thyroid C-cell mass compared with controls.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeC-cell mass
    Study

    ratn: not reported in source

    Rat C-cell mass study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 52 weeksAs given in this study (rat).

    Source sentences

    Summary
    Dulaglutide increased focal C-cell hyperplasia; however, quantitative increases in C-cell mass did not occur.
    1 context sentence
    Summary · context
    In a 52-week study designed to quantitate C-cell mass and plasma calcitonin responses, rats received twice-weekly sc injections of dulaglutide 0 or 5 mg/kg.
  11. 11AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide did not affect diffuse C-cell hyperplasia incidence during the initial 52 weeks in rats.

    In plain wordsIn rats, dulaglutide did not change widespread thyroid C-cell overgrowth compared with controls during the initial 52 weeks.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeDiffuse C-cell hyperplasia
    Study

    ratn: not reported in source

    Rat C-cell mass study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 52 weeksAs given in this study (rat).

    Source sentences

    Summary
    Consistent with the lack of morphometric changes in C-cell mass, dulaglutide did not affect the incidence of diffuse C-cell hyperplasia or basal or calcium-stimulated plasma calcitonin,
    1 context sentence
    Summary · context
    In a 52-week study designed to quantitate C-cell mass and plasma calcitonin responses, rats received twice-weekly sc injections of dulaglutide 0 or 5 mg/kg.
  12. 12AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide did not affect basal plasma calcitonin during the initial 52 weeks in rats.

    In plain wordsIn rats, dulaglutide did not change basal calcitonin compared with controls during the initial 52 weeks.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeBasal plasma calcitonin
    Study

    ratn: not reported in source

    Rat C-cell mass study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 52 weeksAs given in this study (rat).

    Source sentences

    Summary
    Consistent with the lack of morphometric changes in C-cell mass, dulaglutide did not affect the incidence of diffuse C-cell hyperplasia or basal or calcium-stimulated plasma calcitonin,
    1 context sentence
    Summary · context
    In a 52-week study designed to quantitate C-cell mass and plasma calcitonin responses, rats received twice-weekly sc injections of dulaglutide 0 or 5 mg/kg.
  13. 13AnimalAnimal study (in vivo)Safety outcome

    Dulaglutide did not affect calcium-stimulated plasma calcitonin during the initial 52 weeks in rats.

    In plain wordsIn rats, dulaglutide did not change stimulated calcitonin compared with controls during the initial 52 weeks.

    Peptide
    Dulaglutide (Trulicity)
    Outcome
    No significant changeCalcium-stimulated plasma calcitonin
    Study

    ratn: not reported in source

    Rat C-cell mass study
    Comparator
    Control
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    5 mg/kg twice weekly · subcutaneous · 52 weeksAs given in this study (rat).

    Source sentences

    Summary
    Consistent with the lack of morphometric changes in C-cell mass, dulaglutide did not affect the incidence of diffuse C-cell hyperplasia or basal or calcium-stimulated plasma calcitonin,
    1 context sentence
    Summary · context
    In a 52-week study designed to quantitate C-cell mass and plasma calcitonin responses, rats received twice-weekly sc injections of dulaglutide 0 or 5 mg/kg.

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, 02:26 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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