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Study · Randomized controlled trial · n = 32 · 2024

10 results

A phase 1, randomized, double-blind, placebo-controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects.

Xie P, Abildlund MT, Bækdal TA, He X, Lyauk YK, Patted URH, Ning Z, Shi A

Diabetes, obesity & metabolism29 May 2024Cited by 8 (Europe PMC)

PMID38808476 (opens in a new tab)DOI10.1111/dom.15624 (opens in a new tab)PepBankPUB-38808476
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: CC BY-NC. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, steady-state semaglutide exposure (AUC 0-24 h) with 3 mg oral semaglutide was 233 h·nmol/L.

    In plain wordsIn healthy Chinese adults, 3 mg oral semaglutide gave a steady-state exposure of 233 h·nmol/L.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide AUC0-24h at steady state, 3 mg
    Study

    n = 32

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    3 mg · oral · 12 weeksAs given in this study (human).

    Measurements

    AUC0-24h,sema,SS
    233 h·nmol/L
    3 mg oral semaglutide

    Source sentences

    Summary
    determined by AUC0-24h,sema,SS (233, 552 and 1288 h·nmol/L for 3, 7 and 14 mg of oral semaglutide, respectively)
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, steady-state semaglutide exposure (AUC 0-24 h) with 7 mg oral semaglutide was 552 h·nmol/L.

    In plain wordsIn healthy Chinese adults, 7 mg oral semaglutide gave a steady-state exposure of 552 h·nmol/L.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide AUC0-24h at steady state, 7 mg
    Study

    n = 32

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    7 mg · oral · 12 weeksAs given in this study (human).

    Measurements

    AUC0-24h,sema,SS
    552 h·nmol/L
    7 mg oral semaglutide

    Source sentences

    Summary
    determined by AUC0-24h,sema,SS (233, 552 and 1288 h·nmol/L for 3, 7 and 14 mg of oral semaglutide, respectively)
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, steady-state semaglutide exposure (AUC 0-24 h) with 14 mg oral semaglutide was 1288 h·nmol/L.

    In plain wordsIn healthy Chinese adults, 14 mg oral semaglutide gave a steady-state exposure of 1288 h·nmol/L.

    Peptide
    Semaglutide
    Outcome
    Not applicableSemaglutide AUC0-24h at steady state, 14 mg
    Study

    n = 32

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    14 mg · oral · 12 weeksAs given in this study (human).

    Measurements

    AUC0-24h,sema,SS
    1288 h·nmol/L
    14 mg oral semaglutide

    Source sentences

    Summary
    determined by AUC0-24h,sema,SS (233, 552 and 1288 h·nmol/L for 3, 7 and 14 mg of oral semaglutide, respectively)
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy Chinese adults, steady-state maximum semaglutide concentration rose with oral semaglutide dose.

    In plain wordsIn healthy Chinese adults, the peak semaglutide level in blood rose as the oral dose went up.

    Peptide
    Semaglutide
    Outcome
    IncreaseSemaglutide Cmax at steady state
    Study

    n = 32

    Analysis
    Secondary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment with all oral semaglutide doses showed dose-dependent increases in semaglutide exposure in healthy Chinese subjects at steady state, determined by AUC0-24h,sema,SS (233, 552 and 1288 h·nmol/L for 3, 7 and 14 mg of oral semaglutide, respectively) and Cmax,sema,SS.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In healthy Chinese adults, oral semaglutide significantly reduced body weight versus placebo at the end of treatment.

    In plain wordsIn healthy Chinese adults, oral semaglutide lowered body weight more than placebo after 12 weeks.

    Peptide
    Semaglutide
    Outcome
    DecreaseBody weight versus placebo
    Study

    n = 32

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Oral semaglutide treatment was associated with significant reductions in body weight (p = .0001)
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In healthy Chinese adults, oral semaglutide significantly reduced fasting plasma glucose versus placebo at the end of treatment.

    In plain wordsIn healthy Chinese adults, oral semaglutide lowered fasting blood glucose more than placebo after 12 weeks.

    Peptide
    Semaglutide
    Outcome
    DecreaseFasting plasma glucose versus placebo
    Study

    n = 32

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Oral semaglutide treatment was associated with significant reductions in body weight (p = .0001) and fasting plasma glucose (p = .0011) versus placebo at the end of treatment.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, oral semaglutide caused no severe or blood-glucose-confirmed symptomatic hypoglycaemic events.

    In plain wordsIn healthy Chinese adults, oral semaglutide caused no severe low blood sugar events.

    Peptide
    Semaglutide
    Outcome
    No significant changeSevere or confirmed symptomatic hypoglycaemia
    Study

    n = 32

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    with no severe or blood-glucose-confirmed symptomatic hypoglycaemic events, serious adverse events or deaths.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, there were no serious adverse events with oral semaglutide.

    In plain wordsIn healthy Chinese adults, oral semaglutide caused no serious side effects.

    Peptide
    Semaglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 32

    Outcome group
    Adverse events · Whole body
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    with no severe or blood-glucose-confirmed symptomatic hypoglycaemic events, serious adverse events or deaths.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  9. 09HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, there were no deaths with oral semaglutide.

    In plain wordsIn healthy Chinese adults, no one died during oral semaglutide treatment.

    Peptide
    Semaglutide
    Outcome
    No significant changeDeaths
    Study

    n = 32

    Outcome group
    Mortality · Whole body
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    with no severe or blood-glucose-confirmed symptomatic hypoglycaemic events, serious adverse events or deaths.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.
  10. 10HumanRandomized controlled trialSafety outcome

    In healthy Chinese adults, the most frequent adverse events with oral semaglutide were gastrointestinal disorders.

    In plain wordsIn healthy Chinese adults, the most common side effects of oral semaglutide were stomach and bowel problems.

    Peptide
    Semaglutide
    Outcome
    Not applicableMost frequent adverse events
    Study

    n = 32

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 to 14 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most frequent adverse events were gastrointestinal disorders.
    1 context sentence
    Summary · context
    This single-centre, multiple-dose, placebo-controlled trial randomized 32 healthy Chinese adults to once-daily oral semaglutide (3 mg escalating to 14 mg) or placebo for 12 weeks.

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 1NCT04016974

A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

Novo Nordisk A/Sn = 328 Oct 2019 to 26 Feb 2021

Healthy Volunteers · Diabetes Mellitus, Type 2

Trial pageClinicalTrials.govUpdated 12 Jul 2024

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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