Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults.

Lean ME, Carraro R, Finer N, Hartvig H, Lindegaard ML, Rössner S, Van Gaal L, Astrup A

International journal of obesity (2005)14 Aug 2013Cited by 135 (Europe PMC)

PMID23942319PMCIDPMC4010971DOI10.1038/ijo.2013.149PepBankPUB-23942319

Read at source 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialSafety outcome
In obese non-diabetic adults, more participants reported at least one episode of nausea or vomiting with liraglutide 1.2-3.0 mg (17-38%) than with placebo or orlistat (both 4%) in year 1.
In plain wordsIn obese adults without diabetes, nausea or vomiting was reported more often with liraglutide than with placebo or orlistat in the first year.
Peptide
Liraglutide
Outcome
IncreaseNausea or vomiting (at least 1 episode) in year 1
Study
n = 561
Comparator
Placebo or orlistat
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.2-3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Measurements
Participants with nausea/vomiting
17 to 38%
liraglutide 1.2-3.0 mg
Participants with nausea/vomiting
4%
placebo
Participants with nausea/vomiting
4%
orlistat
Source sentences
Summary
In year 1, more participants reported ⩾1 episode of nausea/vomiting on treatment with liraglutide 1.2-3.0 mg (17-38%) than with placebo or orlistat (both 4%, P⩽0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231901
02HumanRandomized controlled trialSafety outcome
In obese non-diabetic adults on liraglutide 3.0 mg, 48% reported some nausea.
In plain wordsIn obese adults without diabetes taking liraglutide 3.0 mg, 48% reported some nausea.
Peptide
Liraglutide
Outcome
Not applicableNausea reported, liraglutide 3.0 mg
Study
n = 93
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Measurements
Participants with nausea
48%
liraglutide 3.0 mg
Source sentences
Summary
Among participants on liraglutide 3.0 mg, 48% reported some nausea
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231902
03HumanRandomized controlled trialSafety outcome
In obese non-diabetic adults on liraglutide 3.0 mg, 13% reported some vomiting.
In plain wordsIn obese adults without diabetes taking liraglutide 3.0 mg, 13% reported some vomiting.
Peptide
Liraglutide
Outcome
Not applicableVomiting reported, liraglutide 3.0 mg
Study
n = 93
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Measurements
Participants with vomiting
13%
liraglutide 3.0 mg
Source sentences
Summary
Among participants on liraglutide 3.0 mg, 48% reported some nausea and 13% some vomiting
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231903
04HumanRandomized controlled trialSafety outcome
In obese non-diabetic adults on liraglutide 3.0 mg, 4 of 93 participants (4%) reported withdrawals.
In plain wordsIn obese adults without diabetes taking liraglutide 3.0 mg, 4 of 93 people (4%) reported withdrawals.
Peptide
Liraglutide
Outcome
Not applicableWithdrawals, liraglutide 3.0 mg
Study
n = 93
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Measurements
Withdrawals
4 participants
liraglutide 3.0 mg, of 93
Source sentences
Summary
but only 4 out of 93 (4%) reported withdrawals.
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231904
05HumanRandomized controlled trialEfficacy outcome
In obese non-diabetic adults on liraglutide 3.0 mg, weight loss, with or without nausea/vomiting, was significantly greater than with placebo.
In plain wordsIn obese adults without diabetes, liraglutide 3.0 mg led to more weight loss than placebo, whether or not nausea or vomiting occurred.
Peptide
Liraglutide
Outcome
Increase1-year weight loss versus placebo
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Source sentences
Summary
Both weight losses were significantly greater than the respective weight losses for participants on placebo (P<0.001) or orlistat (P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
The mean 1-year weight loss on treatment with liraglutide 3.0 mg from randomization was 9.2 kg for participants reporting nausea/vomiting episodes, versus 6.3 kg for those with none (a treatment difference of 2.9 kg (95% confidence interval 0.5-5.3); P=0.02).
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231906
06HumanRandomized controlled trialEfficacy outcome
In obese non-diabetic adults on liraglutide 3.0 mg, weight loss, with or without nausea/vomiting, was significantly greater than with orlistat.
In plain wordsIn obese adults without diabetes, liraglutide 3.0 mg led to more weight loss than orlistat, whether or not nausea or vomiting occurred.
Peptide
Liraglutide
Outcome
Increase1-year weight loss versus orlistat
Study
n: not reported in source
Comparator
Orlistat
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Source sentences
Summary
Both weight losses were significantly greater than the respective weight losses for participants on placebo (P<0.001) or orlistat (P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
The mean 1-year weight loss on treatment with liraglutide 3.0 mg from randomization was 9.2 kg for participants reporting nausea/vomiting episodes, versus 6.3 kg for those with none (a treatment difference of 2.9 kg (95% confidence interval 0.5-5.3); P=0.02).
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231907
07HumanRandomized controlled trialSafety outcome
In obese non-diabetic adults on liraglutide, most nausea and vomiting episodes occurred during dose escalation (weeks 1-6) and were mild or moderate.
In plain wordsIn obese adults without diabetes taking liraglutide, most nausea and vomiting happened in the first weeks of raising the dose and was mild or moderate.
Peptide
Liraglutide
Outcome
Not applicableTiming and severity of nausea and vomiting episodes
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.2-3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Source sentences
Summary
Most episodes occurred during dose escalation (weeks 1-6), with 'mild' or 'moderate' symptoms.
Report a problemFND-2394231909
08HumanObservational studyEfficacy outcome
In obese non-diabetic adults on liraglutide 3.0 mg, 1-year weight loss was greater in participants who reported nausea or vomiting (9.2 kg) than in those with none (6.3 kg).
In plain wordsIn obese adults without diabetes on liraglutide 3.0 mg, nausea or vomiting was linked to greater one-year weight loss than no nausea or vomiting.
Peptide
Liraglutide
Outcome
Increase1-year weight loss by nausea/vomiting status
Study
n: not reported in source
Comparator
Liraglutide 3.0 mg without nausea/vomiting
Outcome group
Body weight · Metabolic and weight
Studied dose
3.0 mg · subcutaneous · 1 yearAs given in this study (human).
Measurements
Weight loss
9.2 kg
with nausea/vomiting
Weight loss
6.3 kg
no nausea/vomiting
Treatment difference
2.9 kg
95% CI 0.5-5.3
Source sentences
Summary
The mean 1-year weight loss on treatment with liraglutide 3.0 mg from randomization was 9.2 kg for participants reporting nausea/vomiting episodes, versus 6.3 kg for those with none (a treatment difference of 2.9 kg (95% confidence interval 0.5-5.3); P=0.02).
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231905
09HumanObservational studyEfficacy outcome
In obese non-diabetic adults on liraglutide 3.0 mg, quality-of-life scores at 20 weeks improved similarly with or without nausea or vomiting.
In plain wordsIn obese adults without diabetes on liraglutide 3.0 mg, quality of life improved similarly whether or not nausea or vomiting occurred.
Peptide
Liraglutide
Outcome
No significant changeQuality-of-life score at 20 weeks by nausea/vomiting status
Study
n: not reported in source
Comparator
Liraglutide 3.0 mg without nausea/vomiting
Outcome group
Adverse events · Whole body
Studied dose
3.0 mg · subcutaneous · 20 weeksAs given in this study (human).
Source sentences
Summary
Quality-of-life scores at 20 weeks improved similarly with or without nausea/vomiting on treatment with liraglutide 3.0 mg.
1 context sentence(design, population, supporting numbers)
Summary · context
After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day).
Report a problemFND-2394231908

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 2Results postedNCT00422058

The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Novo Nordisk A/Sn = 56410 Jan 2007 to 30 Apr 2009

Metabolism and Nutrition Disorder · Obesity

Trial page ClinicalTrials.govUpdated 1 Nov 2017

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
12 Oct 2026, 12:10 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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