Metabolic Dysfunction-Associated Steatotic Liver DiseasePhase 4NCT07274644
Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease
A Phase 4 study testing iGlarLixi and IGlar U100 in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Diabetes Mellitus Type 2, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Diabetes Mellitus Type 2
- What is being tested?
- iGlarLixi and IGlar U100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2025to 30 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus.
- Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%.
- HbA1c ≥ 9.0% at screening.
- Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change < 10% in the past 3 months).
- Stable antidiabetic regimen for at least 3 months prior to screening.
Who cannot join
- 1. History of excessive alcohol consumption (≥210 g/week for men, ≥140 g/week for women).
- 2. Other known causes of chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis).
- 3. Use of medications known to affect liver fat content (e.g., thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, systemic corticosteroids) within 3 months prior to screening.
- 4. Presence of acute infections or diabetic acute complications (e.g., ketoacidosis, hyperosmolar state) within 2 weeks prior to screening.
- 5. History of pancreatitis or elevated amylase/lipase > 3 times the upper limit of normal (ULN).
- 6. Significant liver impairment (ALT or AST > 3 × ULN). 7. Moderate to severe renal impairment (eGFR < 60 mL/min/1.73m²). 8. Congestive heart failure (NYHA class III-IV). 9. Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN-2).
- 10. Severe gastrointestinal disease. 11. Contraindications to MRI examination. 12. Pregnancy or lactation. 13. Participation in another investigational drug study within 6 months prior to enrollment.
- 14. Known hypersensitivity to the study drugs or their excipients.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial
This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.
Read the detailed description
This study is designed as a single-center, randomized, open-label, parallel controlled trial. A total of 36 participants with T2DM and MASLD (defined by MRI-PDFF ≥10%) will be randomized in a 1:1 ratio to receive either once-daily iGlarLixi or iGlar, both in combination with metformin, for 12 weeks. The primary outcome is the change in liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to week 12. Key secondary outcomes include changes in liver enzymes, liver inflammation, fibrosis indices (assessed by transient elastography and FIB-4 index), body composition (weight, BMI, waist circumference, waist-to-hip ratio, and visceral fat area), glycemic control (HbA1c, fasting and postprandial glucose), insulin function, lipid profiles, and uric acid. Safety assessments will include monitoring of hypoglycemic events, gastrointestinal adverse events, and other adverse events.
- Being tested
- iGlarLixi, IGlar U100
- 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.
iGlarLixiDrug
The iGlarLixi is administered as a subcutaneous injection once daily within 1 hour before breakfast. The starting dose ranges from 0.1 to 0.2 U/kg, with a maximum daily dose of 20 U (equivalent to 20 U iGlar or 20 μg Lixi). Dose titration is guided by fasting self-monitored plasma glucose (SMPG) levels, with the goal of achieving a target range of 4.4-5.6 mmol/L while avoiding hypoglycemia. All participants continue to receive background metformin therapy throughout the treatment period.
IGlar U100Drug
The iGlar is administered via subcutaneous injection once daily at a fixed time. The recommended starting dose ranges from 0.1 to 0.2 U/kg. The dose is subsequently titrated to achieve a fasting self-monitored plasma glucose (SMPG) target of 4.4-5.6 mmol/L, with careful attention to avoiding hypoglycemia. Throughout the study, all participants maintain their background metformin therapy
| Study group | Role | What they receive |
|---|---|---|
| iGlarLixi group | Experimental | Participants receive iGlarLixi once daily before breakfast for 12 weeks. Receives: Drug: iGlarLixi |
| iGlar group | Other | Participants receive iGlar once daily at a fixed time for 12 weeks. Receives: Drug: IGlar U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline to Week 12 in hepatic fat fraction
The absolute change of liver fat content were measured by MRI-PDFF
Measured: Baseline, Week 12
Secondary outcomes (16)
Percent change from baseline to Week 12 in hepatic fat fraction
The relative changes of liver fat content were measured by MRI-PDFF
Measured: Baseline, Week 12
Percentage of participants with at least 30% relative fat reduction at Week 12
The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% as measured by MRI-PDFF at Week 12.
Measured: week 12
Changes of liver transaminase
The changes of liver transaminase were measured by ALT, AST, γ-GGT.
Measured: Baseline, 12 weeks
Changes of liver inflammation index
The changes of liver inflammation index were measured by TE.
Measured: Baseline, 12 weeks
Changes of liver stiffness measurement
The changes of liver stiffness measurement were measured by MRE.
Measured: Baseline, 12 weeks
Changes of FIB-4 index
The changes of liver fibrosis can be measured by FIB-4 index.
Measured: Baseline, 12 weeks
Changes of body weight
The changes of body weight were measured by InBody-770 equipment.
Measured: Baseline, 12 weeks
Changes of visceral fat area
The changes of visceral fat area were measured by InBody-770 equipment.
Measured: Baseline, Week 12
Changes of percent body fat
The changes of percent body fat were measured by InBody-770 equipment.
Measured: Baseline, Week 12
Changes of skeletal muscle mass index
The changes of skeletal muscle mass index were measured by InBody-770 equipment.
Measured: Baseline, Week 12
Changes of HbA1c
The changes of glucose metabolism indexes were measured by HbA1c.
Measured: Baseline, 12 weeks
Changes of plasma glucose
The changes of glucose metabolism indexes were measured by fasting plasma glucose and 2-h postprandial plasma glucose.
Measured: Baseline, 12 weeks
Changes of C-peptide
The changes of glucose metabolism indexes were measured by fasting C-peptide and 2-h postprandial C-peptide.
Measured: Baseline, 12 weeks
Changes of lipid metabolism indexes
The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.
Measured: Baseline, 12 weeks
Changes of uric acid
Changes of uric acid will be assessed and compared between treatment groups.
Measured: Baseline, Week 12
Changes of urine albumin to creatinine ratio
Changes of urine albumin to creatinine ratio will be assessed and compared between treatment groups.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start29 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, Study director, Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274644
- Sponsor's protocol ID
- 2024-325-03
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07274644
- Acronym / sponsor ID
- 2024-325-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- 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.
This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.
Detailed description
This study is designed as a single-center, randomized, open-label, parallel controlled trial. A total of 36 participants with T2DM and MASLD (defined by MRI-PDFF ≥10%) will be randomized in a 1:1 ratio to receive either once-daily iGlarLixi or iGlar, both in combination with metformin, for 12 weeks. The primary outcome is the change in liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to week 12. Key secondary outcomes include changes in liver enzymes, liver inflammation, fibrosis indices (assessed by transient elastography and FIB-4 index), body composition (weight, BMI, waist circumference, waist-to-hip ratio, and visceral fat area), glycemic control (HbA1c, fasting and postprandial glucose), insulin function, lipid profiles, and uric acid. Safety assessments will include monitoring of hypoglycemic events, gastrointestinal adverse events, and other adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iGlarLixi group | Experimental | Drug: iGlarLixiParticipants receive iGlarLixi once daily before breakfast for 12 weeks. |
| iGlar group | Other | Drug: IGlar U100Participants receive iGlar once daily at a fixed time for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Type 2 Diabetes Mellitus.
- Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%.
- HbA1c ≥ 9.0% at screening.
- Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change < 10% in the past 3 months).
- Stable antidiabetic regimen for at least 3 months prior to screening.
Key exclusion criteria (8 listed)
- 1. History of excessive alcohol consumption (≥210 g/week for men, ≥140 g/week for women).
- 2. Other known causes of chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis).
- 3. Use of medications known to affect liver fat content (e.g., thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, systemic corticosteroids) within 3 months prior to screening.
- 4. Presence of acute infections or diabetic acute complications (e.g., ketoacidosis, hyperosmolar state) within 2 weeks prior to screening.
- 5. History of pancreatitis or elevated amylase/lipase > 3 times the upper limit of normal (ULN).
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 |
|---|---|---|
| iGlarLixiThe iGlarLixi is administered as a subcutaneous injection once daily within 1 hour before breakfast. The starting dose ranges from 0.1 to 0.2 U/kg, with a maximum daily dose of 20 U (equivalent to 20 U iGlar or 20 μg Lixi). Dose titration is guided by fasting self-monitored plasma glucose (SMPG) levels, with the goal of achieving a target range of 4.4-5.6 mmol/L while avoiding hypoglycemia. All participants continue to receive background metformin therapy throughout the treatment period. | Drug | iGlarLixi group |
| IGlar U100The iGlar is administered via subcutaneous injection once daily at a fixed time. The recommended starting dose ranges from 0.1 to 0.2 U/kg. The dose is subsequently titrated to achieve a fasting self-monitored plasma glucose (SMPG) target of 4.4-5.6 mmol/L, with careful attention to avoiding hypoglycemia. Throughout the study, all participants maintain their background metformin therapy | Drug | iGlar group |
Primary outcome
Absolute change from baseline to Week 12 in hepatic fat fraction
Time frame: Baseline, Week 12
The absolute change of liver fat content were measured by MRI-PDFF
16 secondary outcomes
Percent change from baseline to Week 12 in hepatic fat fraction
Time frame: Baseline, Week 12
Percentage of participants with at least 30% relative fat reduction at Week 12
Time frame: week 12
Changes of liver transaminase
Time frame: Baseline, 12 weeks
Changes of liver inflammation index
Time frame: Baseline, 12 weeks
Changes of liver stiffness measurement
Time frame: Baseline, 12 weeks
Changes of FIB-4 index
Time frame: Baseline, 12 weeks
Changes of body weight
Time frame: Baseline, 12 weeks
Changes of visceral fat area
Time frame: Baseline, Week 12
Changes of percent body fat
Time frame: Baseline, Week 12
Changes of skeletal muscle mass index
Time frame: Baseline, Week 12
Changes of HbA1c
Time frame: Baseline, 12 weeks
Changes of plasma glucose
Time frame: Baseline, 12 weeks
Changes of C-peptide
Time frame: Baseline, 12 weeks
Changes of lipid metabolism indexes
Time frame: Baseline, 12 weeks
Changes of uric acid
Time frame: Baseline, Week 12
Changes of urine albumin to creatinine ratio
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Yan Bi study director
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
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 iGlarLixi and IGlar U100 in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Diabetes Mellitus Type 2, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Absolute change from baseline to Week 12 in hepatic fat fraction (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.