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Could a diabetes combo drug melt liver fat better than insulin alone?

NCT ID NCT07274644

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a combination diabetes drug (iGlarLixi) against insulin alone to see which better reduces liver fat in people with type 2 diabetes and a common fatty liver condition called MASLD. About 36 participants will take one of the two treatments for 12 weeks, and doctors will measure liver fat using MRI scans. The goal is to find a more effective way to manage both blood sugar and liver health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iGlarLixi (a combination of insulin glargine and lixisenatide)
What this could lead to
If successful, this could show that iGlarLixi is a better option than insulin alone for reducing liver fat in people with type 2 diabetes and fatty liver disease.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply to everyone. The study is also open-label, meaning both patients and doctors know which treatment is given, which can introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of Type 2 Diabetes Mellitus. 2. Diagnosis of MASLD with liver fat content defined by MRI-PDFF ≥ 10%. 3. HbA1c ≥ 9.0% at screening. 4. Body Mass Index (BMI) between 25.0 and 35.0 kg/m², with stable weight (change \< 10% in the past 3 months). 5. Stable antidiabetic regimen for at least 3 months prior to screening. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

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