Study · Randomized controlled trial · n = 3,731 · 2015

6 results

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP

The New England journal of medicine1 Jul 2015Cited by 1,954 (Europe PMC)

PMID26132939DOI10.1056/nejmoa1411892PepBankPUB-26132939

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight without type 2 diabetes, liraglutide 3.0 mg reduced body weight more than placebo at week 56.
In plain wordsIn adults with obesity or overweight without diabetes, liraglutide lowered body weight more than placebo after 56 weeks.
Peptide
Liraglutide
Outcome
DecreaseChange in body weight at week 56
Study
n = 3,731
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Weight difference vs placebo
−5.6 kg
week 56
Weight loss
8.4 kg
liraglutide
Weight loss
2.8 kg
placebo
Source sentences
Summary
At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293901
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight without type 2 diabetes, more patients on liraglutide than on placebo lost at least 5% of body weight.
In plain wordsIn adults with obesity or overweight without diabetes, more people on liraglutide than on placebo lost at least 5% of their body weight.
Peptide
Liraglutide
Outcome
IncreaseProportion losing at least 5% of body weight
Study
n = 3,731
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Proportion losing >=5% weight
63.2%
liraglutide
Proportion losing >=5% weight
27.1%
placebo
Source sentences
Summary
A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293902
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight without type 2 diabetes, more patients on liraglutide than on placebo lost more than 10% of body weight.
In plain wordsIn adults with obesity or overweight without diabetes, more people on liraglutide than on placebo lost more than 10% of their body weight.
Peptide
Liraglutide
Outcome
IncreaseProportion losing more than 10% of body weight
Study
n = 3,731
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Proportion losing >10% weight
33.1%
liraglutide
Proportion losing >10% weight
10.6%
placebo
Source sentences
Summary
A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293903
04HumanRandomized controlled trialSafety outcome
In adults with obesity or overweight without type 2 diabetes, mild or moderate nausea was among the most frequently reported adverse events with liraglutide.
In plain wordsIn adults with obesity or overweight without diabetes, mild or moderate nausea was one of the most common side effects of liraglutide.
Peptide
Liraglutide
Outcome
Direction not reportedNausea
Study
n = 3,731
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293904
05HumanRandomized controlled trialSafety outcome
In adults with obesity or overweight without type 2 diabetes, mild or moderate diarrhea was among the most frequently reported adverse events with liraglutide.
In plain wordsIn adults with obesity or overweight without diabetes, mild or moderate diarrhea was one of the most common side effects of liraglutide.
Peptide
Liraglutide
Outcome
Direction not reportedDiarrhea
Study
n = 3,731
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Source sentences
Summary
The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293905
06HumanRandomized controlled trialSafety outcome
In adults with obesity or overweight without type 2 diabetes, serious events occurred in 6.2% of the liraglutide group and 5.0% of the placebo group, with no test reported.
In plain wordsIn adults with obesity or overweight without diabetes, serious events occurred in 6.2% on liraglutide and 5.0% on placebo.
Peptide
Liraglutide
Outcome
Direction not reportedSerious events
Study
n = 3,731
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg once daily · subcutaneous · 56 weeksAs given in this study (human).
Measurements
Serious events
6.2%
liraglutide
Serious events
5%
placebo
Source sentences
Summary
Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
Summary · context
We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification.
Report a problemFND-2613293906

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials6

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

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Trial page ClinicalTrials.govUpdated 17 Jun 2026

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Trial page ClinicalTrials.govUpdated 20 Nov 2024

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Combined Effects of GLP-1 Analogue and Exercise on Maintenance of Weight Loss and Health After Very-low Calorie Diet

Signe Torekovn = 215Sept 2016 to est. Nov 2021

Obesity

Trial page ClinicalTrials.govUpdated 2 Nov 2020

CompletedPhase 4NCT02616003

Preoperative Condition in Giant Obese Patients

Sana Klinikum Offenbachn = 50Apr 2014 to Apr 2018

Morbid Obesity · Bariatric Surgery Candidate

Trial page ClinicalTrials.govUpdated 23 Mar 2021

CompletedPhase 3Results postedNCT01272219

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Novo Nordisk A/Sn = 3,7311 Jun 2011 to 2 Mar 2015

Metabolism and Nutrition Disorder · Obesity

Trial page ClinicalTrials.govUpdated 19 Jan 2018

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
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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