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Study · Observational study · n = 11,220 · 2026

8 results

Hepatic Safety of Orforglipron in Adults With Obesity or Overweight and/or Type 2 Diabetes: A Pooled Analysis of the Orforglipron Phase 3 Clinical Trials.

Wharton S, Stefanski A, Chen J, Rao G, Twum EA, Denning M

Diabetes, obesity & metabolism23 Jun 2026Cited by 2 (Europe PMC)

PMID42338042 (opens in a new tab)PMCIDPMC13448879 (opens in a new tab)DOI10.1111/dom.71032 (opens in a new tab)PepBankPUB-42338042
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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. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, concurrent enzyme and bilirubin elevations affected six orforglipron-treated participants, with similar reported comparator incidence.

    In plain wordsIn adults with obesity, overweight and/or diabetes, concurrent liver enzyme and bilirubin elevations had similar reported incidence with orforglipron and comparators.

    Peptide
    Orforglipron
    Outcome
    No significant changeConcurrent aminotransferase and bilirubin elevations
    Study

    n = 11,220

    Comparator
    Pooled placebo, oral semaglutide, dapagliflozin and insulin glargine
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Measurements

    Participants with ALT or AST >= 3 x ULN and TBIL >= 2 x ULN (n)
    6 participants
    orforglipron-treated
    Participants with ALT or AST >= 3 x ULN and TBIL >= 2 x ULN
    0.1%
    orforglipron-treated
    Participants with ALT or AST >= 3 x ULN and TBIL >= 2 x ULN (n)
    6 participants
    comparator-treated
    Participants with ALT or AST >= 3 x ULN and TBIL >= 2 x ULN
    0.1%
    comparator-treated

    Source sentences

    Summary
    Six (0.1%) orforglipron-treated participants and six (0.1%) comparator-treated participants had ALT or AST ≥ 3 × ULN and TBIL ≥ 2 × ULN; however, alternative etiologies accounted for all orforglipron cases and thus did not meet criteria for drug induced liver injury/Hy's Law.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  2. 02HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, hepatic adverse-event incidence was balanced between orforglipron and pooled comparators.

    In plain wordsIn adults with obesity, overweight and/or diabetes, liver adverse-event incidence was balanced between orforglipron and pooled comparators.

    Peptide
    Orforglipron
    Outcome
    No significant changeHepatic adverse events
    Study

    n = 11,220

    Comparator
    Pooled comparators
    Outcome group
    Adverse events · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    The incidence of hepatic AEs was balanced between orforglipron and pooled comparators, suggesting no increased risk with orforglipron.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  3. 03HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, all orforglipron cases with concurrent enzyme and bilirubin elevations had alternative etiologies and failed liver-injury criteria.

    In plain wordsIn adults with obesity, overweight and/or diabetes, orforglipron cases with concurrent liver abnormalities had alternative causes and failed liver-injury criteria.

    Peptide
    Orforglipron
    Outcome
    Not applicableDrug-induced liver injury or Hy's Law
    Study

    n = 6,920

    Outcome group
    Adverse events · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Measurements

    Orforglipron-treated participants with ALT or AST >= 3 x ULN and TBIL >= 2 x ULN, none meeting DILI/Hy's Law criteria
    6 participants
    orforglipron-treated

    Source sentences

    Summary
    Six (0.1%) orforglipron-treated participants and six (0.1%) comparator-treated participants had ALT or AST ≥ 3 × ULN and TBIL ≥ 2 × ULN; however, alternative etiologies accounted for all orforglipron cases and thus did not meet criteria for drug induced liver injury/Hy's Law.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  4. 04HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, orforglipron treatment was associated with mean ALT reductions from baseline.

    In plain wordsIn adults with obesity, overweight and/or diabetes, orforglipron treatment was linked to lower ALT from baseline.

    Peptide
    Orforglipron
    Outcome
    DecreaseMean ALT
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    Orforglipron treatment was associated with mean reductions in ALT/AST.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  5. 05HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, orforglipron treatment was associated with mean AST reductions from baseline.

    In plain wordsIn adults with obesity, overweight and/or diabetes, orforglipron treatment was linked to lower AST from baseline.

    Peptide
    Orforglipron
    Outcome
    DecreaseMean AST
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    Orforglipron treatment was associated with mean reductions in ALT/AST.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  6. 06HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, categorical ALT elevations were generally balanced between orforglipron and comparators.

    In plain wordsIn adults with obesity, overweight and/or diabetes, ALT elevations were generally balanced between orforglipron and comparators.

    Peptide
    Orforglipron
    Outcome
    No significant changeCategorical ALT elevations
    Study

    n: not reported in source

    Comparator
    Comparators
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    Categorical ALT/AST elevations were generally balanced between orforglipron and comparators.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  7. 07HumanObservational studySafety outcome

    In adults with obesity, overweight and/or diabetes, categorical AST elevations were generally balanced between orforglipron and comparators.

    In plain wordsIn adults with obesity, overweight and/or diabetes, AST elevations were generally balanced between orforglipron and comparators.

    Peptide
    Orforglipron
    Outcome
    No significant changeCategorical AST elevations
    Study

    n: not reported in source

    Comparator
    Comparators
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    Categorical ALT/AST elevations were generally balanced between orforglipron and comparators.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.
  8. 08HumanObservational studyOther

    In adults with obesity, overweight and/or diabetes, orforglipron hepatic results were consistent across normal and elevated baseline aminotransferase groups.

    In plain wordsIn adults with obesity, overweight and/or diabetes, orforglipron liver results were consistent across normal and elevated baseline liver enzyme groups.

    Peptide
    Orforglipron
    Outcome
    No significant changeHepatic result consistency by baseline aminotransferases
    Study

    n: not reported in source

    Comparator
    Normal versus elevated baseline aminotransferases
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · oral · up to 104 weeks, including safety follow-upAs given in this study (human).

    Source sentences

    Summary
    Results were consistent in participants with normal and elevated baseline aminotransferases.
    2 context sentences
    Summary · context
    The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
    Summary · context
    Overall, 11 220 participants were included in this analysis (orforglipron N = 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine] N = 4300) for up to 104 weeks, including safety follow-up.

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. Versions 4 to 15Current

    28 Oct 2026, 02:03 UTC

    The same notice was added 12 times, first on 14 Oct 2026, 05:02 UTC. The status did not change between them.

    Study results updated

  2. Version 3

    14 Oct 2026, 01:46 UTC

    Study data updated · source update from Europe PMC

  3. Version 2

    11 Oct 2026, 00:04 UTC

    Study results updated

  4. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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