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Can a diabetes drug shrink fatty liver in thyroid patients?

NCT ID NCT06373523

Disease control Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether dapagliflozin, a drug used for diabetes, can reduce liver fat in people with underactive thyroid (hypothyroidism) who also have non-alcoholic fatty liver disease (NAFLD). Half of the 50 participants will take dapagliflozin daily, and the other half will take a placebo, for 28 weeks. Researchers will measure liver fat using MRI and liver stiffness using elastography at the start, middle, and end of the study. The goal is to see if the drug can improve liver health in this group, who currently have limited treatment options.

What this could mean

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

Active substance
Dapagliflozin 10 mg tablet taken daily
What this could lead to
If it works, dapagliflozin could become a new treatment option for fatty liver disease in people with underactive thyroid, especially those who cannot manage the condition with lifestyle changes alone.
What could go wrong
This is a small early-stage trial, so the drug may not prove effective or safe in this specific group. Also, dapagliflozin is not currently approved for fatty liver disease without diabetes, and its benefits are uncertain.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

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

Started

Jan 2024

Expected to finish

Dec 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 75 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. Age 18-75 years 2. Patients with Overt Primary hypothyroidism (Low FT3/Low FT4 and TSH\>ULN) Exclusion Criteria: 1. Patients with Diabetes Mellitus(T1DM AND T2DM) 2. Patient with Secondary Hypothyroidism 3. Patients with other Endocrinopathies who are at risk of MASLD (T1DM and T2DM, Growth Hormone Insufficiency,Cushing Syndrome) 4. Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases (chronic viral hepatitis infection, autoimmune hepatitis, Wilson's disease, hemochromatosis, congestive hepatopathy, primary biliary cholangitis, primary sclerosing cholangitis, biliary tract obstruction) 5. Patient with Drug Induced Liver Injury(DILI) 6. Patients with Decompensated Cirrhosis or Portal hypertensionPatients with Cirrhosis or Portal hypertension 7. Patients with HCC or any other malignancy 8. Drugs like OCPS 9. Patients \<18 years of age 10. Patients already on Vitamin E or pioglitazone 11. Pregnancy/Lactation 12. Patients who are too sick to carry out the protocol 13. Those who do not consent to participate in the study

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Conditions

The condition(s) this trial relates to.

hypothyroidism metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Hepatic steato-fibrosis Non-alcoholic fatty liver disease

Contacts and locations

Locations

  • Postgraduate Institute of Medical Education and Research

    Chandigarh, Punjab, 160012, India

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