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Study · Randomized controlled trial · n = 667 · 2023

7 results

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial.

Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT

Lancet (London, England)26 Jun 2023Cited by 315 (Europe PMC)

PMID37385278 (opens in a new tab)DOI10.1016/s0140-6736(23)01185-6 (opens in a new tab)PepBankPUB-37385278
Publisher pagePubMedAsk about this study
Jump to 7 results

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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity without type 2 diabetes, oral semaglutide 50 mg daily reduced bodyweight by 15.1% versus 2.4% with placebo at week 68.

    In plain wordsIn adults with overweight or obesity, oral semaglutide lost far more body weight than placebo over 68 weeks.

    Peptide
    Semaglutide
    Outcome
    DecreasePercentage change in bodyweight at week 68
    Study

    n = 667

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Mean bodyweight change
    −15.1%
    oral semaglutide 50 mg
    Mean bodyweight change
    −2.4%
    placebo
    Estimated treatment difference
    −12.7 percentage points
    vs placebo

    Source sentences

    Summary
    The estimated mean bodyweight change from baseline to week 68 was -15·1% (SE 0·5) with oral semaglutide 50 mg versus -2·4% (0·5) with placebo (estimated treatment difference -12·7 percentage points, 95% CI -14·2 to -11·3; p<0·0001).
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity without type 2 diabetes, more participants reached a bodyweight reduction of at least 5% with oral semaglutide 50 mg than with placebo (85% vs 26%).

    In plain wordsIn adults with overweight or obesity, many more people lost at least 5% of body weight with oral semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseBodyweight reduction of at least 5% at week 68
    Study

    n = 612

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with weight reduction >=5%
    85%
    oral semaglutide 50 mg
    Participants with weight reduction >=5%
    26%
    placebo

    Source sentences

    Summary
    More participants reached bodyweight reductions of at least 5% (269 [85%] of 317 vs 76 [26%] of 295; odds ratio [OR] 12·6, 95% CI 8·5 to 18·7; p<0·0001)
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity without type 2 diabetes, adverse events were more frequent with oral semaglutide 50 mg than with placebo (92% vs 86%).

    In plain wordsIn adults with overweight or obesity, side effects of any kind were somewhat more common with oral semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseAdverse events (any)
    Study

    n = 667

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with adverse events
    92%
    oral semaglutide 50 mg
    Participants with adverse events
    86%
    placebo

    Source sentences

    Summary
    Adverse events were more frequent with oral semaglutide 50 mg (307 [92%] of 334) than with placebo (285 [86%] of 333).
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with overweight or obesity without type 2 diabetes, gastrointestinal adverse events, mostly mild to moderate, were more frequent with oral semaglutide 50 mg than with placebo (80% vs 46%).

    In plain wordsIn adults with overweight or obesity, stomach and gut side effects were more common with oral semaglutide than with placebo, mostly mild to moderate.

    Peptide
    Semaglutide
    Outcome
    IncreaseGastrointestinal adverse events
    Study

    n = 667

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with gastrointestinal adverse events
    80%
    oral semaglutide 50 mg
    Participants with gastrointestinal adverse events
    46%
    placebo

    Source sentences

    Summary
    Gastrointestinal adverse events (mostly mild to moderate) were reported in 268 (80%) participants with oral semaglutide 50 mg and 154 (46%) with placebo.
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity without type 2 diabetes, more participants reached a bodyweight reduction of at least 10% with oral semaglutide 50 mg than with placebo (69% vs 12%).

    In plain wordsIn adults with overweight or obesity, many more people lost at least 10% of body weight with oral semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseBodyweight reduction of at least 10% at week 68
    Study

    n = 612

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with weight reduction >=10%
    69%
    oral semaglutide 50 mg
    Participants with weight reduction >=10%
    12%
    placebo

    Source sentences

    Summary
    10% (220 [69%] vs 35 [12%]; OR 14·7, 9·6 to 22·6)
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity without type 2 diabetes, more participants reached a bodyweight reduction of at least 15% with oral semaglutide 50 mg than with placebo (54% vs 6%).

    In plain wordsIn adults with overweight or obesity, many more people lost at least 15% of body weight with oral semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseBodyweight reduction of at least 15% at week 68
    Study

    n = 612

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with weight reduction >=15%
    54%
    oral semaglutide 50 mg
    Participants with weight reduction >=15%
    6%
    placebo

    Source sentences

    Summary
    15% (170 [54%] vs 17 [6%]; OR 17·9, 10·4 to 30·7)
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with overweight or obesity without type 2 diabetes, more participants reached a bodyweight reduction of at least 20% with oral semaglutide 50 mg than with placebo (34% vs 3%).

    In plain wordsIn adults with overweight or obesity, many more people lost at least 20% of body weight with oral semaglutide than with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseBodyweight reduction of at least 20% at week 68
    Study

    n = 612

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    50 mg once per day · oral · 68 weeksAs given in this study (human).

    Measurements

    Participants with weight reduction >=20%
    34%
    oral semaglutide 50 mg
    Participants with weight reduction >=20%
    3%
    placebo

    Source sentences

    Summary
    20% (107 [34%] vs 8 [3%]; OR 18·5, 8·8 to 38·9)
    2 context sentences
    Summary · context
    This randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with bodyweight-related complications and comorbidities, without type 2 diabetes.
    Summary · context
    Participants were randomly allocated (1:1) via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once per day for 68 weeks, plus lifestyle intervention.

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05035095

Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

Novo Nordisk A/Sn = 66713 Sept 2021 to 12 May 2023

Obesity · Overweight

Trial pageClinicalTrials.govUpdated 7 May 2026

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, 00:50 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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