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Study · Observational study · 2026

3 results

Efficacy, Safety and PK of Once-Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model-Informed Drug Development Approach.

Overgaard RV, Birkhan O, Rathor N, Sparsø T, Strathe A, Wharton S, Rubino D

Diabetes, obesity & metabolism23 Apr 2026Cited by 4 (Europe PMC)

PMID42023428 (opens in a new tab)PMCIDPMC13243942 (opens in a new tab)DOI10.1111/dom.70769 (opens in a new tab)PepBankPUB-42023428
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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 study3

3 results from studies that gave the peptide. 1 result from people.

  1. 01HumanObservational studyPharmacokinetics

    In OASIS 4, most participants given oral semaglutide 25 mg reached exposure levels in the same range as participants given once-weekly subcutaneous semaglutide 2.4 mg in STEP 1.

    In plain wordsMost people taking daily oral semaglutide 25 mg had blood levels in the same range as people taking weekly semaglutide 2.4 mg injections.

    Peptide
    Semaglutide
    Outcome
    Not applicableExposure of oral semaglutide 25 mg versus subcutaneous semaglutide 2.4 mg
    Study

    n: not reported in source

    Comparator
    Subcutaneous semaglutide 2.4 mg (STEP 1)
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    25 mg · oralAs given in this study (human).

    Measurements

    Proportion within subcutaneous exposure range
    82.2%
    oral semaglutide 25 mg, OASIS 4

    Source sentences

    Summary
    Most participants (82.2%) treated with oral semaglutide 25 mg in OASIS 4 achieved exposure levels within the same range as participants treated with once-weekly subcutaneous semaglutide 2.4 mg in STEP 1.
    1 context sentence
    Summary · context
    To fulfil health authority approval requirements, population pharmacokinetic and exposure-response analyses were used to extrapolate efficacy and safety data from subcutaneous to oral semaglutide.
  2. 02Computer modelIn silicoEfficacy outcome

    In a simulated trial of people with overweight/obesity and type 2 diabetes, oral semaglutide 25 mg gave greater weight reduction than placebo.

    In plain wordsIn a computer simulation, oral semaglutide 25 mg gave more weight loss than placebo in a virtual group with obesity and type 2 diabetes.

    Peptide
    Semaglutide
    Outcome
    DecreaseWeight reduction versus placebo in overweight/obesity with type 2 diabetes (simulated)
    Study

    humann: not reported in source

    Simulated Phase 3 trial
    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    25 mg · oralAs given in this study (human).

    Measurements

    Weight reduction
    9.4%
    trial product estimand, with T2D
    Weight reduction
    7.8%
    treatment policy estimand, with T2D

    Source sentences

    Summary
    In the simulated studies, oral semaglutide 25 mg provided significantly greater weight reduction compared with placebo, for the trial product estimand and treatment policy estimand, respectively, in those with overweight/obesity and T2D (9.4% and 7.8%), and in those with overweight/obesity without T…
    2 context sentences
    Summary · context
    Two studies were simulated: a modelled/virtual Phase 2 trial to establish efficacy across different oral semaglutide dose levels, and a modelled/virtual Phase 3 trial to assess efficacy in a population with overweight/obesity and T2D.
    Summary · context
    To fulfil health authority approval requirements, population pharmacokinetic and exposure-response analyses were used to extrapolate efficacy and safety data from subcutaneous to oral semaglutide.
  3. 03Computer modelIn silicoEfficacy outcome

    In a simulated trial of people with overweight/obesity without type 2 diabetes, oral semaglutide 25 mg gave greater weight reduction than placebo.

    In plain wordsIn a computer simulation, oral semaglutide 25 mg gave more weight loss than placebo in a virtual group with obesity and no diabetes.

    Peptide
    Semaglutide
    Outcome
    DecreaseWeight reduction versus placebo in overweight/obesity without type 2 diabetes (simulated)
    Study

    humann: not reported in source

    Simulated Phase 2 trial
    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    25 mg · oralAs given in this study (human).

    Measurements

    Weight reduction
    16.3%
    trial product estimand, without T2D
    Weight reduction
    14.7%
    treatment policy estimand, without T2D

    Source sentences

    Summary
    In the simulated studies, oral semaglutide 25 mg provided significantly greater weight reduction compared with placebo, for the trial product estimand and treatment policy estimand, respectively, in those with overweight/obesity and T2D (9.4% and 7.8%), and in those with overweight/obesity without T…
    2 context sentences
    Summary · context
    Two studies were simulated: a modelled/virtual Phase 2 trial to establish efficacy across different oral semaglutide dose levels, and a modelled/virtual Phase 3 trial to assess efficacy in a population with overweight/obesity and T2D.
    Summary · context
    To fulfil health authority approval requirements, population pharmacokinetic and exposure-response analyses were used to extrapolate efficacy and safety data from subcutaneous to oral semaglutide.

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

    11 Oct 2026, 00:04 UTC

    Study results updated

  2. 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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