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Can a diabetes drug combo revive the Body's growth hormone axis and protect the liver?

NCT ID NCT07778719

Disease control Sponsor: The 95th Hospital of Putian，Putian, Fujian, China Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing whether adding dapagliflozin to metformin can improve levels of a growth-related hormone (IGF-1) in men with type 2 diabetes and fatty liver disease. The study will include 84 men aged 30-60 who are already taking metformin. Half will continue metformin alone, while the other half will also take dapagliflozin for 3 months. Researchers will measure changes in IGF-1, liver fat, and liver stiffness to see if the combination offers extra benefits.

What this could mean

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

Active substance
metformin combined with dapagliflozin
What this could lead to
If adding dapagliflozin to metformin restores the body's growth hormone signaling, it could point to a better way to protect the liver in people with type 2 diabetes and fatty liver disease.
What could go wrong
This is a small, early-stage trial with only 84 men, so results may not apply to everyone. The study is open-label, meaning both patients and doctors know the treatment, 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 84 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

30 to 60 years

Sex

Male participants only

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. Males aged 30-60 years; 2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%; 3. Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks; 4. Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB/m detected, with the presence of at least one cardiometabolic risk factor; 5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists; 6. Willing to participate voluntarily and sign the informed consent form. Exclusion Criteria: 1. Type 1 diabetes mellitus or other specific types of diabetes; 2. Weekly alcohol intake exceeding 210g for males; 3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.); 4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis; 5. Previous or current use of GH preparations or IGF-1 preparations; 6. Baseline estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m²; 7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis); 8. Active malignant tumors; 9. Allergy to dapagliflozin or similar drugs; 10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months; 11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

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

Metabolic dysfunction-associated steatotic liver disease Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ethics Committee of Putian 95 Hospital

    Putian, Fujian, 351100, China

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