Could a diabetes drug reverse liver scarring?

NCT ID NCT06005012

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether semaglutide, a drug already used for obesity and type 2 diabetes, can reduce liver scarring in people with non-alcoholic fatty liver disease (NAFLD). Participants are adults aged 40 to 80 who are overweight or have type 2 diabetes. The trial will also validate a screening method to identify those at high risk for advanced liver disease.

What this could mean

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

Active substance
semaglutide, a GLP-1 receptor agonist drug approved for obesity and type 2 diabetes
What this could lead to
If successful, this could provide a treatment option for liver scarring in people with fatty liver disease, potentially preventing progression to cirrhosis.
What could go wrong
This is a phase 2 trial with 120 participants, so results are preliminary. Semaglutide may not reduce fibrosis in all patients, and side effects like nausea or gastrointestinal issues are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Started

Jul 2023

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

40 to 79 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. Adult, age ≥ 40 and \< 80 years 2. Participant must meet at least one of following sets of conditions: 1. BMI ≥ 27 kg/m² OR 2. BMI ≥ 25 kg/m² AND presence of i) pre-diabetes (HbA1C ≥ 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations. The ADA definition of T2DM is applicable if one of the following criteria is met: * Presence of diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) and casual plasma glucose ≥ 200 mg/dL (11.1 mmol/L) * Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/L) * Plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT)⁶⁸. If any of the above test results occur, testing should be repeated on a different day to confirm the diagnosis. OR • Hemoglobin A1C (HbA1C) ≥ 6.5% ⁶⁹. 3. FAST score ≥ 0.5 and VCTE ≥ 8.0 kPa; FAST score threshold based on data from MAESTRO-NASH trial⁴²; VCTE cutpoint based on AASLD guidelines for identification of patients with significant fibrosis risk. 4. Participants without a VCTE assessment in their medical record may qualify for the study if they have a FIB-4 ≥ 1.0, which is a cutpoint based on observations of patients with T2DM in Ajmera et al³⁰, and VCTE ≥ 8.0 kPa. 5. The subject is fully informed and willing and able to perform all the procedures specified in the protocol and has signed a written informed consent to participate Exclusion criteria: 1. Presence of regular and/or excessive use of alcohol, defined as \> 30 g/day for males and \> 20 g/day for females, for a period longer than 2 years at any time in the last 10 years 2. Evidence of cirrhosis or previously known cirrhosis, based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices 3. VCTE ≥ 20 kPa 4. Platelet count ≤ 140,000 per Ml 5. Albumin \< 3.6 g/dL 6. INR \> 1.35, unless on coumadin for another indication 7. Serum creatinine \> 2.0 mg/dL 8. eGFR \< 30 mL/min/1.73 m² as defined according to the CKDEPI creatinine equation⁷⁰ 9. Use of other weight loss medications, including GLP1RA within the last 90 days 10. Greater than 10% weight loss in the prior six months 11. Known or suspected hypersensitivity to GLP1RA medications including semaglutide 12. History of bariatric surgery within the past 5 years or expected bariatric surgery 13. Evidence of other causes of chronic liver disease including: 1. Hepatitis B, as defined as presence of hepatitis B surface antigen (HBsAg). 2. Previous or current infection with Hepatitis C, as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab). 3. Autoimmune hepatitis, as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. 4. Autoimmune cholestatic liver disorders, as defined by elevation of alkaline phosphatase and anti- mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. 5. Wilson disease, as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease deficiency, as defined by alpha-1-antitrypsin phenotype and liver histology consistent with alpha-1-antitrypsin deficiency.

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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

  • University of California, San Diego

    La Jolla, California, 92093, United States

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