Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.

Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT

The New England journal of medicine1 Sept 2025Cited by 54 (Europe PMC)

PMID40934115DOI10.1056/nejmoa2500969PepBankPUB-40934115

Publisher page PubMedAsk about this study

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.

01HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, oral semaglutide 25 mg reduced body weight by 13.6% versus 2.2% with placebo at week 64 (difference 11.4 percentage points).
In plain wordsIn adults with overweight or obesity, oral semaglutide 25 mg led to much more weight loss than placebo.
Peptide
Semaglutide
Outcome
DecreasePercent change in body weight at week 64
Study
n = 307
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Measurements
Body weight change
−13.6%
oral semaglutide
Body weight change
−2.2%
placebo
Estimated difference
−11.4 percentage points
vs placebo
Source sentences
Summary
The estimated mean change in body weight from baseline to week 64 was -13.6% in the oral semaglutide group and -2.2% in the placebo group (estimated difference, -11.4 percentage points; 95% confidence interval, -13.9 to -9.0; P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411501
02HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, more participants on oral semaglutide 25 mg than on placebo had a body-weight reduction of 5% or more.
In plain wordsIn adults with overweight or obesity, more people on oral semaglutide 25 mg lost at least 5% of body weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBody-weight reduction of 5% or more
Study
n = 307
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Source sentences
Summary
Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411502
03HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, more participants on oral semaglutide 25 mg than on placebo had a body-weight reduction of 10% or more.
In plain wordsIn adults with overweight or obesity, more people on oral semaglutide 25 mg lost at least 10% of body weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBody-weight reduction of 10% or more
Study
n = 307
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Source sentences
Summary
Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411503
04HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, more participants on oral semaglutide 25 mg than on placebo had a body-weight reduction of 15% or more.
In plain wordsIn adults with overweight or obesity, more people on oral semaglutide 25 mg lost at least 15% of body weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBody-weight reduction of 15% or more
Study
n = 307
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Source sentences
Summary
Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411504
05HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, more participants on oral semaglutide 25 mg than on placebo had a body-weight reduction of 20% or more.
In plain wordsIn adults with overweight or obesity, more people on oral semaglutide 25 mg lost at least 20% of body weight than on placebo.
Peptide
Semaglutide
Outcome
IncreaseBody-weight reduction of 20% or more
Study
n = 307
Comparator
Placebo
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Source sentences
Summary
Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411505
06HumanRandomized controlled trialEfficacy outcome
In adults with overweight or obesity, oral semaglutide 25 mg improved the IWQOL-Lite-CT Physical Function score more than placebo.
In plain wordsIn adults with overweight or obesity, oral semaglutide 25 mg improved physical function scores more than placebo.
Peptide
Semaglutide
Outcome
IncreaseIWQOL-Lite-CT Physical Function score
Study
n = 307
Comparator
Placebo
Analysis
Secondary
Outcome group
Exercise and physical function · Metabolic and weight
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Source sentences
Summary
Participants in the oral semaglutide group were significantly more likely than those in the placebo group to have body-weight reductions of 5% or more, 10% or more, 15% or more, and 20% or more (P<0.001 for all comparisons) and to have an improved IWQOL-Lite-CT Physical Function score (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411506
07HumanRandomized controlled trialSafety outcome
In adults with overweight or obesity, gastrointestinal adverse events were more common with oral semaglutide 25 mg than with placebo (74.0% vs. 42.2%).
In plain wordsIn adults with overweight or obesity, stomach and bowel side effects were more common with oral semaglutide 25 mg than with placebo.
Peptide
Semaglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 307
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
25 mg once daily · oral · 71 weeksAs given in this study (human).
Measurements
Gastrointestinal adverse events
74%
oral semaglutide
Gastrointestinal adverse events
42.2%
placebo
Source sentences
Summary
Gastrointestinal adverse events were more common with oral semaglutide than with placebo (74.0% vs. 42.2%).
2 context sentences(design, population, supporting numbers)
Summary · context
In a 71-week, double-blind, randomized, placebo-controlled trial conducted at 22 sites in four countries, we enrolled persons without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least…
Summary · context
The participants were randomly assigned in a 2:1 ratio to receive oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions.
Report a problemFND-4093411507

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 postedNCT05564117

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

Novo Nordisk A/Sn = 30711 Oct 2022 to 7 May 2024

Overweight · Obesity

Trial page ClinicalTrials.govUpdated 25 Feb 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.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
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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