Safety and efficacy of liraglutide in patients with type 2 diabetes and elevated liver enzymes: individual patient data meta-analysis of the LEAD program.

Armstrong MJ, Houlihan DD, Rowe IA, Clausen WH, Elbrønd B, Gough SC, Tomlinson JW, Newsome PN

Alimentary pharmacology & therapeutics19 Nov 2012Cited by 186 (Europe PMC)

PMID23163663DOI10.1111/apt.12149PepBankPUB-23163663

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanSystematic reviewEfficacy outcome
In adults with type 2 diabetes and abnormal baseline ALT, liraglutide 1.8 mg reduced ALT more than placebo over 26 weeks.
In plain wordsIn adults with type 2 diabetes and raised liver enzyme levels, liraglutide 1.8 mg lowered ALT more than placebo.
Peptide
Liraglutide
Outcome
DecreaseALT change in patients with abnormal baseline ALT (1.8 mg)
Study
n = 2,241
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
ALT change
−8.2 IU/L
liraglutide 1.8 mg
ALT change
−5.01 IU/L
placebo
Source sentences
Summary
Liraglutide 1.8 mg reduced ALT in these patients vs. placebo (-8.20 vs. -5.01 IU/L; P = 0.003)
2 context sentences(design, population, supporting numbers)
Summary · context
Of 4442 patients analysed, 2241 (50.8%) patients had an abnormal ALT at baseline [mean ALT 33.8(14.9) IU/L in females; 47.3(18.3) IU/L in males].
Summary · context
Individual patient data meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program.
Report a problemFND-2316366301
02HumanSystematic reviewEfficacy outcome
In adults with type 2 diabetes and abnormal baseline ALT, liraglutide 0.6 mg and 1.2 mg did not reduce ALT significantly more than placebo.
In plain wordsIn adults with type 2 diabetes and raised liver enzyme levels, liraglutide 0.6 and 1.2 mg did not lower ALT more than placebo.
Peptide
Liraglutide
Outcome
No significant changeALT change in patients with abnormal baseline ALT (0.6 and 1.2 mg)
Study
n = 2,241
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
0.6 or 1.2 mg · 26 weeksAs given in this study (human).
Source sentences
Summary
and was dose-dependent (no significant differences vs. placebo with liraglutide 0.6 or 1.2 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
Of 4442 patients analysed, 2241 (50.8%) patients had an abnormal ALT at baseline [mean ALT 33.8(14.9) IU/L in females; 47.3(18.3) IU/L in males].
Summary · context
Individual patient data meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program.
Report a problemFND-2316366302
03HumanSystematic reviewEfficacy outcome
After adjustment for weight reduction, the ALT difference between liraglutide 1.8 mg and placebo was no longer significant.
In plain wordsAfter allowing for weight loss, liraglutide 1.8 mg no longer lowered ALT more than placebo did.
Peptide
Liraglutide
Outcome
No significant changeALT difference versus placebo after adjusting for weight loss
Study
n = 2,241
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
ALT difference vs placebo
−1.41 IU/L
adjusted for weight
Source sentences
Summary
This effect was lost after adjusting for liraglutide's reduction in weight (mean ALT difference vs. placebo -1.41 IU/L, P = 0.21) and HbA1c (+0.57 IU/L, P = 0.63).
2 context sentences(design, population, supporting numbers)
Summary · context
Of 4442 patients analysed, 2241 (50.8%) patients had an abnormal ALT at baseline [mean ALT 33.8(14.9) IU/L in females; 47.3(18.3) IU/L in males].
Summary · context
Individual patient data meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program.
Report a problemFND-2316366303
04HumanSystematic reviewEfficacy outcome
After adjustment for HbA1c reduction, the ALT difference between liraglutide 1.8 mg and placebo was no longer significant.
In plain wordsAfter allowing for blood sugar control, liraglutide 1.8 mg no longer lowered ALT more than placebo did.
Peptide
Liraglutide
Outcome
No significant changeALT difference versus placebo after adjusting for HbA1c
Study
n = 2,241
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
ALT difference vs placebo
0.57 IU/L
adjusted for HbA1c
Source sentences
Summary
This effect was lost after adjusting for liraglutide's reduction in weight (mean ALT difference vs. placebo -1.41 IU/L, P = 0.21) and HbA1c (+0.57 IU/L, P = 0.63).
2 context sentences(design, population, supporting numbers)
Summary · context
Of 4442 patients analysed, 2241 (50.8%) patients had an abnormal ALT at baseline [mean ALT 33.8(14.9) IU/L in females; 47.3(18.3) IU/L in males].
Summary · context
Individual patient data meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program.
Report a problemFND-2316366304
05HumanSystematic reviewSafety outcome
Adverse effects with liraglutide 1.8 mg were similar in patients with and without abnormal baseline ALT.
In plain wordsSide effects of liraglutide 1.8 mg were similar in people with and without raised liver enzymes at the start.
Peptide
Liraglutide
Outcome
No significant changeAdverse effects by baseline ALT status
Study
n: not reported in source
Comparator
Patients without abnormal baseline ALT
Outcome group
Adverse events · Whole body
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Source sentences
Summary
Adverse effects with 1.8 mg liraglutide were similar between patients with and without baseline abnormal ALT.
1 context sentence(design, population, supporting numbers)
Summary · context
Individual patient data meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program.
Report a problemFND-2316366305
06HumanSystematic reviewEfficacy outcome
In the LEAD-2 sub-study, liraglutide 1.8 mg showed a non-significant trend towards improved CT-measured hepatic steatosis versus placebo.
In plain wordsIn a sub-study, liraglutide 1.8 mg showed a trend towards less liver fat than placebo, but the difference was not significant.
Peptide
Liraglutide
Outcome
No significant changeHepatic steatosis (liver-to-spleen attenuation ratio) in LEAD-2 sub-study
Study
n: not reported in source
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
Liver-to-spleen attenuation ratio change
0.1
liraglutide 1.8 mg
Liver-to-spleen attenuation ratio change
0
placebo
Source sentences
Summary
In LEAD-2 sub-study, liraglutide 1.8 mg showed a trend towards improving hepatic steatosis vs. placebo (liver-to-spleen attenuation ratio +0.10 vs. 0.00; P = 0.07).
1 context sentence(design, population, supporting numbers)
Summary · context
The LEAD-2 sub-study was analysed to assess the effect on CT-measured hepatic steatosis.
Report a problemFND-2316366306
07HumanSystematic reviewEfficacy outcome
After correction for weight change, the difference in hepatic steatosis between liraglutide 1.8 mg and placebo was reduced and not significant.
In plain wordsAfter allowing for weight change, liraglutide 1.8 mg showed no clear difference from placebo in liver fat.
Peptide
Liraglutide
Outcome
No significant changeHepatic steatosis difference after adjusting for weight change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
Liver-to-spleen attenuation ratio difference
0.06
adjusted for weight
Source sentences
Summary
This difference was reduced when correcting for changes in weight (+0.06, P = 0.25) and HbA(1c) (0.00, P = 0.93).
1 context sentence(design, population, supporting numbers)
Summary · context
The LEAD-2 sub-study was analysed to assess the effect on CT-measured hepatic steatosis.
Report a problemFND-2316366307
08HumanSystematic reviewEfficacy outcome
After correction for HbA1c change, the difference in hepatic steatosis between liraglutide 1.8 mg and placebo was reduced to zero and not significant.
In plain wordsAfter allowing for blood sugar control, liraglutide 1.8 mg showed no difference from placebo in liver fat.
Peptide
Liraglutide
Outcome
No significant changeHepatic steatosis difference after adjusting for HbA1c
Study
n: not reported in source
Comparator
Placebo
Outcome group
Liver fat and liver function · Liver
Studied dose
1.8 mg · 26 weeksAs given in this study (human).
Measurements
Liver-to-spleen attenuation ratio difference
0
adjusted for HbA1c
Source sentences
Summary
This difference was reduced when correcting for changes in weight (+0.06, P = 0.25) and HbA(1c) (0.00, P = 0.93).
1 context sentence(design, population, supporting numbers)
Summary · context
The LEAD-2 sub-study was analysed to assess the effect on CT-measured hepatic steatosis.
Report a problemFND-2316366308

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

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

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