LIRA-NAFLD/LIP

TerminatedPhase 4

Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

Effect of Liraglutide on Fatty Liver Content Evaluated by Proton-spectroscopy (1H-spectroscopy) and Lipoprotein Kinetic, in Patients With Type 2 Diabetes

Lead sponsor

Centre Hospitalier Universitaire Dijon

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

127

actual

Study population

Dyslipidemia, Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoints

•Liver fat content, change•Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein•Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02721888

Org study IDVERGES NOVO 2012

Timeline

Milestones

Study start2012-07-10actual

Study first posted2016-03-29estimated

Primary completion2019-10-02actual

Last update posted2026-02-06actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

DyslipidemiaType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes

•Patients treated by metformin and/or sulfonylureas (or glinides) and/or acarbose and/or insulin,

•HbA1C >= 7 %,

•Patients who gave their written consent.

For the kinetic substudy:

•Patients who have the typical features of diabetic dyslipidemia (triglycerides >= 1.50 g/l and/or HDL<0.50 g/l [women], 0.40 g/l [men])

Exclusion criteria

•Treatment with thiazolidinediones or other Glucagon-like peptide-1(GLP1) agonist.

•No treatment with a Dipeptidyl peptidase-4 (DPP4) inhibitor during the 3 previous months,

•Renal or hepatic failure,

•Contra-indication for proton-spectroscopy (pacemaker, implantable prosthesis,..),

•Pregnancy.

For the kinetic substudy:

•Patients on hypolipidemic agents

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

MASH / liver

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Modification of body weight

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI)

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Modification of visceral fat by Magnetic Resonance Imaging (MRI)

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Visceral fat, change

change from baseline, improvement

MASH / liver

1 endpoint

Primary/protocol endpoint

Effect of liraglutide on fatty liver content evaluated by proton-spectroscopy (1H-spectroscopy and lipoprotein kinetics, in patients with type 2 diabetes

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

Primary/protocol endpoint

Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein B (apoB) production rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint/low confidence

Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein B (apoB) production rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint

Effects of liraglutide on Intermediate Density Lipoprotein (IDL) apolipoprotein B (apoB) production rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

ApoB, change

change from baseline, improvement

Primary/protocol endpoint

Effects of liraglutide on Low Density Lipoprotein (LDL) apolipoprotein B (apoB) production rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

ApoB, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Effects of liraglutide on High Density Lipoprotein (HDL) apolipoprotein A1 (apoA1) production rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint

Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein B (apoB) fractional catabolic rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint/low confidence

Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein B (apoB) fractional catabolic rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint/low confidence

Effects of liraglutide on Intermediate Density Lipoprotein (IDL) apolipoprotein B (apoB) fractional catabolic rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Primary/protocol endpoint

Effects of liraglutide on Low Density Lipoprotein (LDL) apolipoprotein B (apoB) fractional catabolic rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

ApoB, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Effects of liraglutide on High Density Lipoprotein (HDL) apolipoprotein A1 (apoA1) fractional catabolic rate

Time frame:Before and after 6 month-treatment with liraglutide (1.2 mg/day)

change from baseline, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide reduces plasma dihydroceramide levels in patients with type 2 diabetes.
Cardiovascular diabetology2023 May 4PMID37143040doi:10.1186/s12933-023-01845-0via clinicaltrials gov reference derived + pubmed nct search
Liraglutide Increases the Catabolism of Apolipoprotein B100-Containing Lipoproteins in Patients With Type 2 Diabetes and Reduces Proprotein Convertase Subtilisin/Kexin Type 9 Expression.
Diabetes care2021 Apr (month)PMID33531418doi:10.2337/dc20-1843via clinicaltrials gov reference derived + pubmed nct search
Liraglutide Reduces Postprandial Hyperlipidemia by Increasing ApoB48 (Apolipoprotein B48) Catabolism and by Reducing ApoB48 Production in Patients With Type 2 Diabetes Mellitus.
Arteriosclerosis, thrombosis, and vascular biology2018 Sep (month)PMID30026275doi:10.1161/ATVBAHA.118.310990via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.