Can a weekly injection melt fat hiding in the pancreas?

NCT ID NCT07803705

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether mazdutide, an experimental weekly injection, can reduce fat buildup in the pancreas of adults with overweight or obesity. About 194 participants will receive either mazdutide or a placebo, alongside standard lifestyle advice, for 48 weeks. Researchers will measure changes in pancreatic fat using MRI scans, along with body weight, waist size, and blood sugar and fat levels. The goal is to see if mazdutide can improve fatty pancreas and related metabolic problems.

What this could mean

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

Active substance
mazdutide, an experimental injectable drug given weekly under the skin
What this could lead to
If it works, mazdutide could become a treatment to reduce fatty pancreas and improve metabolic health in people with overweight or obesity.
What could go wrong
This is an early-stage trial with a modest number of participants, so results may not apply broadly. The drug may cause side effects, and the effect on fatty pancreas may be small or absent.

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 194 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 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: Patients participating in this study must meet all of the following criteria: 1. Age 18-60 years (inclusive) at screening, regardless of gender; 2. BMI at screening meets one of the following conditions: ① BMI ≥28 kg/m²; or ② 24 kg/m² ≤ BMI \<28 kg/m², with at least one obesity-related metabolic abnormality (elevated fasting blood glucose, dyslipidemia, hypertension, etc.); 3. Pancreatic MRI-PDFF quantitative assessment completed during the screening period, with intrapancreatic fat deposition (IPFD) ≥6%; 4. Fully informed about the study and voluntarily signed written informed consent; 5. Agreed to maintain a stable lifestyle (including diet and exercise habits) during the study. Note: Diagnostic criteria for Metabolic Syndrome (meeting ≥3 of the following items) \[ChineseDiabetesSociety(CDS)2020\]: 1. Abdominal obesity (central obesity): Waist circumference ≥90 cm in men, ≥85 cm in women; 2. Fasting blood glucose ≥6.1 mmol/L and/or 2-hour postprandial blood glucose ≥7.8 mmol/L, and/or diagnosed diabetes under treatment; 3. Blood pressure ≥130/85 mmHg, and/or diagnosed hypertension under treatment; 4. Fasting triglycerides (TG) ≥1.7 mmol/L; 5. Fasting HDL-C \<1.04 mmol/L. Exclusion Criteria: Patients with any of the following conditions will be excluded from participation in this study: 1. HbA1c ≥6.5% at screening; history of diabetic ketoacidosis (DKA) or other diabetic emergencies; 2. Use of GLP-1 receptor agonists (GLP-1RA), DPP-4 inhibitors, or insulin within 3 months prior to screening; 3. Use of any weight-loss drugs or dietary supplements for fat reduction within 1 month prior to screening enrollment; or use of systemic medications known to cause weight gain within 1 month prior to screening, including systemic glucocorticoids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers; 4. Self-reported or documented significant weight fluctuation (\>5%) within 3 months prior to screening; 5. Current or history of acute pancreatitis, chronic pancreatitis, or gallbladder disease (gallstones, cholecystitis); or serum triglycerides (TG) \>5 mmol/L during the screening period; 6. Chronic kidney disease stage 3 or higher, eGFR \<60 mL/(min·1.73m²) (calculated using the CKD-EPI formula); 7. Obesity secondary to other endocrine disorders, such as Cushing's syndrome; 8. Personal or family history of Multiple Endocrine Neoplasia type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC); 9. History of severe depression, or current severe psychiatric illness (schizophrenia, bipolar disorder, etc.), where the investigator judges that the patient cannot comply with the study procedures; 10. History of allergy to Tirzepatide injection or its excipients; 11. Pregnant or lactating women; women of childbearing potential unwilling to adopt effective contraceptive measures throughout the study and for 3 months after the last dose; 12. Contraindications to MRI examination (e.g., magnetic metal implants in the body, severe claustrophobia), preventing completion of pancreatic MRI-PDFF assessment; 13. Participation in other drug or medical device clinical trials within 3 months prior to screening; 14. Other serious organic diseases judged by the investigator to interfere with efficacy/safety evaluation or pose a risk to subject safety.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

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

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Contacts and locations

Locations

  • TongjHospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

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