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New Dual-Action drug aims to tackle fatty liver where semaglutide falls short

NCT ID NCT07713992

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether switching to a new drug called mazdutide can reduce liver fat more effectively than staying on semaglutide in people with type 2 diabetes and moderate-to-severe fatty liver. Participants who have been on semaglutide for at least 16 weeks are randomly assigned to either switch to mazdutide or continue semaglutide. The main goal is to measure changes in liver fat using MRI and ultrasound.

What this could mean

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

Active substance
a dual GLP-1/glucagon receptor agonist called mazdutide
What this could lead to
If successful, this could offer a new treatment option for people with type 2 diabetes and fatty liver who do not get enough benefit from semaglutide alone.
What could go wrong
This is a relatively small, early-stage trial. The results may not apply to all patients, and mazdutide may cause side effects like nausea or gastrointestinal issues.

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 72 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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 60 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: * Aged between 18 and 60 years (inclusive) at the time of informed consent signing. * Diagnosed with type 2 diabetes mellitus. * Received once-weekly semaglutide 1.0 mg treatment for at least 16 consecutive weeks verified by medication records. * Diagnosed with moderate-to-severe fatty liver, defined as hepatic attenuation ≥269 dB/m by transient elastography and hepatic fat fraction \>10% measured by MRI-PDFF. * HbA1c level \<7%. * Body mass index (BMI) ≥24 kg/m². * Glycemic and weight management regimens without adjustments within 3 months prior to screening. * Voluntarily signed written informed consent and agreed to comply with the study protocol. Exclusion Criteria: * History of alcoholic fatty liver, drug-induced fatty liver, viral hepatitis, autoimmune diseases, or acute gallbladder diseases. * Use of medications affecting fatty liver metabolism within 3 months prior to screening, including but not limited to SGLT-2 inhibitors, vitamin E, GLP-1R/GIPR agonists, liver-selective thyroid receptor β agonists, PPAR agonists, and aspirin. * Use of weight-loss drugs or alternative weight-loss therapies within 3 months prior to screening. * Addition to sulfonylureas, glinides, dorzagliatin, or various insulin preparations within 3 months prior to screening. * History of bariatric surgery or planned bariatric surgery during the study (excluding acupuncture, liposuction and abdominal liposuction performed more than 1 year before screening). * Diagnosed with type 1 diabetes or latent autoimmune diabetes in adults. * Personal history of acute or chronic pancreatitis, personal or family history of medullary thyroid carcinoma (MTC), or family history of multiple endocrine neoplasia type 2 (MEN2). * Presence of severe cardiovascular, cerebrovascular, hepatic or renal insufficiency, uncontrolled diabetes, malignancy, cirrhosis or advanced liver fibrosis. * Pregnant or lactating females, those planning pregnancy within half a year, or with recent major surgery or severe infection. * Mental disorders or cognitive disorders that may interfere with study compliance, or any other conditions judged inappropriate for study participation by the investigator. * Contraindications to MRI examination, including implantation of pacemakers, metallic heart valves, magnetic surgical clips, implantable electronic infusion pumps, severe claustrophobia, or inability to tolerate MRI scanning.

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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.

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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