Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study.

Armstrong MJ, Gaunt P, Aithal GP, Barton D, Hull D, Parker R, Hazlehurst JM, Guo K, Abouda G, Aldersley MA, Stocken D, Gough SC and 4 more

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Tomlinson JW, Brown RM, Hübscher SG, Newsome PN

Lancet (London, England)20 Nov 2015Cited by 1,668 (Europe PMC)

PMID26608256DOI10.1016/s0140-6736(15)00803-xPepBankPUB-26608256

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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 study7

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

01HumanRandomized controlled trialEfficacy outcome
In overweight patients with NASH, more patients had resolution of definite NASH with no worsening in fibrosis with liraglutide (39%) than with placebo (9%) at 48 weeks.
In plain wordsIn overweight patients with NASH, liraglutide cleared the liver disease in more patients than placebo did over 48 weeks.
Peptide
Liraglutide
Outcome
IncreaseResolution of definite NASH with no worsening in fibrosis
Study
n = 45
Comparator
Placebo
Analysis
Primary
Outcome group
Liver fat and liver function · Liver
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Resolution of definite NASH
39%
liraglutide
Resolution of definite NASH
9%
placebo
Source sentences
Summary
Nine (39%) of 23 patients who received liraglutide and underwent end-of-treatment liver biopsy had resolution of definite non-alcoholic steatohepatitis compared with two (9%) of 22 such patients in the placebo group (relative risk 4·3 [95% CI 1·0-17·7]; p=0·019).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome measure was resolution of definite non-alcoholic steatohepatitis with no worsening in fibrosis from baseline to end of treatment (48 weeks), as assessed centrally by two independent pathologists.
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825601
02HumanRandomized controlled trialEfficacy outcome
In overweight patients with NASH, fewer patients had progression of fibrosis with liraglutide (9%) than with placebo (36%).
In plain wordsIn overweight patients with NASH, liver scarring got worse in fewer patients on liraglutide than on placebo.
Peptide
Liraglutide
Outcome
DecreaseProgression of fibrosis
Study
n = 45
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Fibrosis progression
9%
liraglutide
Fibrosis progression
36%
placebo
Source sentences
Summary
Two (9%) of 23 patients in the liraglutide group versus eight (36%) of 22 patients in the placebo group had progression of fibrosis (0·2 [0·1-1·0]; p=0·04).
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825602
03HumanRandomized controlled trialSafety outcome
In overweight patients with NASH, most adverse events were mild to moderate and transient, and similar in the liraglutide and placebo groups, except for gastrointestinal disorders.
In plain wordsIn overweight patients with NASH, apart from stomach and gut problems, side effects were mostly mild and similar with liraglutide and placebo.
Peptide
Liraglutide
Outcome
No significant changeAdverse events other than gastrointestinal disorders
Study
n = 45
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
Most adverse events were grade 1 (mild) to grade 2 (moderate) in severity, transient, and similar in the two treatment groups for all organ classes and symptoms
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825603
04HumanRandomized controlled trialSafety outcome
In overweight patients with NASH, gastrointestinal disorders occurred in 81% of patients with liraglutide and 65% with placebo.
In plain wordsIn overweight patients with NASH, more patients on liraglutide than on placebo had stomach and gut problems.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal disorders
Study
n = 45
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Gastrointestinal disorders
81%
liraglutide
Gastrointestinal disorders
65%
placebo
Source sentences
Summary
gastrointestinal disorders in 21 (81%) of 23 patients in the liraglutide group and 17 (65%) of 22 patients in the placebo group
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825604
05HumanRandomized controlled trialSafety outcome
In overweight patients with NASH, diarrhoea occurred in 38% of patients with liraglutide and 19% with placebo.
In plain wordsIn overweight patients with NASH, diarrhoea was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseDiarrhoea
Study
n = 45
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Diarrhoea
38%
liraglutide
Diarrhoea
19%
placebo
Source sentences
Summary
diarrhoea (ten [38%] patients in the liraglutide group vs five [19%] in the placebo group)
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825605
06HumanRandomized controlled trialSafety outcome
In overweight patients with NASH, constipation occurred in 27% of patients with liraglutide and in none with placebo.
In plain wordsIn overweight patients with NASH, constipation occurred with liraglutide but not with placebo.
Peptide
Liraglutide
Outcome
IncreaseConstipation
Study
n = 45
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Constipation
27%
liraglutide
Source sentences
Summary
constipation (seven [27%] vs none)
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825606
07HumanRandomized controlled trialSafety outcome
In overweight patients with NASH, loss of appetite occurred in 31% of patients with liraglutide and 8% with placebo.
In plain wordsIn overweight patients with NASH, loss of appetite was more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseLoss of appetite
Study
n = 45
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1·8 mg daily · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Loss of appetite
31%
liraglutide
Loss of appetite
8%
placebo
Source sentences
Summary
loss of appetite (eight [31%] vs two [8%])
1 context sentence(design, population, supporting numbers)
Summary · context
This multicentre, double-blinded, randomised, placebo-controlled phase 2 trial was conducted in four UK medical centres to assess subcutaneous injections of liraglutide (1·8 mg daily) compared with placebo for patients who are overweight and show clinical evidence of non-alcoholic steatohepatitis.
Report a problemFND-2660825607

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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 2NCT01237119

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

University of Birminghamn = 52Aug 2010 to Jul 2014

Nonalcoholic Steatohepatitis

Trial page ClinicalTrials.govUpdated 23 Mar 2016

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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