Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus … (NCT07274644) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease
China36 participantsStarted 2025-03-29
Plain-language 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 Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing iGlarLixi — which combines insulin glargine with lixisenatide — against insulin glargine alone, specifically to see which one reduces liver fat more in people who have both type 2 diabetes and metabolic dysfunction-associated steatotic liver disease. Given my specific situation, does it make sense to discuss whether either of these medications could be an option for me?
2Since this is a Phase 4 trial, these medications have already been approved, but the question of whether iGlarLixi specifically helps with liver fat in MASLD is still being studied — what does that mean for how confident we can be about any liver-related benefit compared to the diabetes management benefit we already know about?
3The trial is active but no longer enrolling new participants — is there any way to find out when results might be published, and should we wait for those findings before making decisions about my treatment plan?
4Liver fat content is the main thing being measured here — how would my doctor actually track whether my liver fat is changing on whatever treatment I'm currently on, and what tools or tests are typically used to monitor that?
5Are there other ongoing studies or already-approved treatment pathways specifically targeting liver fat in people with both type 2 diabetes and MASLD that my doctor thinks I should know about while waiting for results from trials like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change from baseline to Week 12 in hepatic fat fraction
Timeframe: Baseline, Week 12
Trial details
NCT IDNCT07274644
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School