CClinicalTrials.gg
Sign In
TerminatedNCT02721888LIRA-NAFLD/LIPUpdated Feb 6, 2026

Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

A Phase 4 interventional study of Liraglutide and MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) in Type 2 Diabetes, sponsored by Centre Hospitalier Universitaire Dijon. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Centre Hospitalier Universitaire Dijon · Phase 4, Interventional, and Treatment

Why this study was terminated
Failure of inclusion

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Jul 2012, registered Feb 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
127
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 127 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Main study

    Drug: Liraglutide · Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) · Biological: Blood sample · Other: Kinetic substudy (10 patients)

Interventions

  • DrugLiraglutide
  • DrugMRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
  • BiologicalBlood sample
  • OtherKinetic substudy (10 patients)
06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Secondary outcomes

  1. Modification of body weight

    Modification of weight, induced by liraglutide 1.2 mg/d therapy.

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

  2. Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI)

    Modification of subcutaneous fat by MRI induced by liraglutide 1.2mg/d therapy

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

  3. Modification of visceral fat by Magnetic Resonance Imaging (MRI)

    Modification of visceral fat by MRI induced by liraglutide 1.2mg/d therapy

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

07

Study locations

1 site
  • CHU de Dijon
    Dijon, 21079, France
08

References and documents

Publications

  • Verges B, Duvillard L, Pais de Barros JP, Bouillet B, Baillot-Rudoni S, Rouland A, Sberna AL, Petit JM, Degrace P, Demizieux L. Liraglutide Reduces Postprandial Hyperlipidemia by Increasing ApoB48 (Apolipoprotein B48) Catabolism and by Reducing ApoB48 Production in Patients With Type 2 Diabetes Mellitus. Arterioscler Thromb Vasc Biol. 2018 Sep;38(9):2198-2206. doi: 10.1161/ATVBAHA.118.310990. PubMed 30026275 ↗
  • Denimal D, Bergas V, Pais-de-Barros JP, Simoneau I, Demizieux L, Passilly-Degrace P, Bouillet B, Petit JM, Rouland A, Bataille A, Duvillard L, Verges B. Liraglutide reduces plasma dihydroceramide levels in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 May 4;22(1):104. doi: 10.1186/s12933-023-01845-0. PubMed 37143040 ↗
  • Verges B, Duvillard L, Pais de Barros JP, Bouillet B, Baillot-Rudoni S, Rouland A, Petit JM, Degrace P, Demizieux L. 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 Care. 2021 Apr;44(4):1027-1037. doi: 10.2337/dc20-1843. Epub 2021 Feb 2. PubMed 33531418 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02721888
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Mar 29, 2016
Start date
Jul 10, 2012
Primary completion
Oct 2, 2019
Last update
Feb 6, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Centre Hospitalier Universitaire Dijon

Start the discussion