Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism (LIRA-NAFLD/LIP)

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

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

Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be associated with lipid abnormalities (such as hypertriglyceridemia and decreased HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type 2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between 3 and 5%).

Animal studies have shown that liraglutide is able to decrease liver fat content, but the effect of liraglutide on liver fat content in patients with diabetes remains unknown.

In addition, human studies with liraglutide have shown significant modification of plasma lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the mechanisms responsible for these liraglutide induced lipid modifications are not yet known.

Because increased in liver fat content and hypertriglyceridemia are associated in patients with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver fat content assessment and kinetic study with stable isotope to study lipoprotein metabolism).

This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide therapy (1.2 mg/day).

Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day hospitalization

For the main study, 3 visits will be performed:

  • a first visit at T0, before starting the treatment with liraglutide, including clinical and biological measurements and liver fat content assessment by proton-spectroscopy
  • a visit at 3 months including clinical and biological measurements
  • and a visit at 6 months including clinical and biological measurements and liver fat content assessment by proton-spectroscopy

For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will been performs during a 48h-hospitalization before starting the treatment with liraglutide and after 6 month-treatment with liraglutide

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main study
Drug: Liraglutide
Biological: Blood sample
Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Other: Kinetic substudy (10 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
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)
Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of body weight
Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of weight, induced by liraglutide 1.2 mg/d therapy.
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI)
Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of subcutaneous fat by MRI induced by liraglutide 1.2mg/d therapy
Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of visceral fat by Magnetic Resonance Imaging (MRI)
Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of visceral fat by MRI induced by liraglutide 1.2mg/d therapy
Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2012

Primary Completion (Actual)

October 2, 2019

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimated)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERGES NOVO 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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