Type 2 DiabetesPhase 4LIRA-NAFLD/LIPNCT02721888
Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism
A Phase 4 study testing Liraglutide, MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) and Blood sample in people with Type 2 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Liraglutide, MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2012to 2 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Type 2 Diabetes
- Being tested
- Liraglutide, MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy), Blood sample, Kinetic substudy (10 patients)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)Drug
Blood sampleBiological
Kinetic substudy (10 patients)Other
| Study group | Role | What they receive |
|---|---|---|
| Main study | Experimental | Not described Receives: Drug: Liraglutide; Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy); Biological: Blood sample; Other: Kinetic substudy (10 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of liraglutide on fatty liver content evaluated by proton-spectroscopy (1H-spectroscopy and lipoprotein kinetics, in patients with type 2 diabetes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Secondary outcomes (3)
Modification of body weight
Modification of weight, induced by liraglutide 1.2 mg/d therapy.
Measured: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI)
Modification of subcutaneous fat by MRI induced by liraglutide 1.2mg/d therapy
Measured: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Modification of visceral fat by Magnetic Resonance Imaging (MRI)
Modification of visceral fat by MRI induced by liraglutide 1.2mg/d therapy
Measured: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start10 Jul 2012
- Primary completion2 Oct 2019
Why it stopped: Failure of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721888
- Sponsor's protocol ID
- VERGES NOVO 2012
- Acronym
- LIRA-NAFLD/LIP
- Status last verified
- Feb 2026
- First submitted
- 29 Feb 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
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 30026275Denimal 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 37143040Verges 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liraglutide on Fatty Liver Content Evaluated by Proton-spectroscopy (1H-spectroscopy) and Lipoprotein Kinetic, in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02721888
- Acronym / sponsor ID
- LIRA-NAFLD/LIP / VERGES NOVO 2012
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of inclusion
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 10 Jul 2012 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study | Experimental | Drug: Liraglutide, Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy), Biological: Blood sample, Other: Kinetic substudy (10 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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])
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide | Drug | Main study |
| MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) | Drug | Main study |
| Blood sample | Biological | Main study |
| Kinetic substudy (10 patients) | Other | Main study |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
3 secondary outcomes
Modification of body weight
Time frame: 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 visceral fat by Magnetic Resonance Imaging (MRI)
Time frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Results and safety
The study was stopped early (reason given: Failure of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 30026275Verges 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.
- Derived from this study: PubMed 37143040Denimal 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.
- Derived from this study: PubMed 33531418Verges 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide, MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) and Blood sample in people with Type 2 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721888, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.