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Can a weekly injection melt fat hiding in the pancreas?

NCT ID NCT07803705

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 18, 2026 · Updated 1 time

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: Participants meeting any of the following conditions will be excluded from this study: Glycated hemoglobin HbA1c ≥7.5% at screening; history of diabetic ketoacidosis (DKA) or other diabetic emergencies; Use within 3 months before screening of glucagon-like peptide-1 receptor (GLP-1R) agonists, GLP-1R/glucagon receptor (GCGR) dual agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, GIPR/GLP-1R/GCGR triple agonists, insulin, or oral antidiabetic drugs other than metformin; Use of any weight-loss drug or fat-reducing dietary supplement within 1 month before screening/enrollment; or use within 1 month before screening of systemic medications that may cause weight gain, including systemic glucocorticoids, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers; Self-reported or documented weight fluctuation of \>5% within 3 months before screening; Current or history of acute pancreatitis or chronic pancreatitis; or serum triglycerides (TG) \>5.6 mmol/L at screening; or history of acute cholecystitis or symptomatic/requiring-treatment gallbladder disease (except participants who have undergone cholecystectomy and are judged by the investigator to be eligible); Chronic kidney disease stage 3 or higher, eGFR \<60 mL/min/1.73 m² (calculated by CKD-EPI formula); Obesity secondary to other endocrine diseases, such as Cushing syndrome; Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (MTC); History of malignancy within 5 years before screening (except cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.); Acute myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 6 months before screening; or New York Heart Association (NYHA) class III or IV heart failure; Acute or chronic hepatitis at screening (except chronic hepatitis B), autoimmune hepatitis, or significantly abnormal liver function: ALT or AST \>3×ULN, or total bilirubin \>2×ULN (except Gilbert syndrome); History of pancreatic injury; imaging findings suggestive of pancreatic space-occupying lesion, pancreatic atrophy, pancreatic calcification, or history of pancreatic surgery that may affect IPFD assessment; Contraindications to MRI examination (e.g., metallic implants in the body, claustrophobia, etc.) or inability to cooperate with breath-holding for the examination; Blood amylase or lipase \>2×ULN at screening; Pregnant or lactating women, or positive pregnancy test at screening; women of childbearing potential who are unwilling to use medically accepted contraception during the study; Allergy to GLP-1 receptor agonists or any component of the study drug; or prior discontinuation of GLP-1 receptor agonist drugs due to safety or tolerability reasons; Participation in another interventional clinical trial within 3 months before screening; History of major depressive disorder, or current severe psychiatric illness (e.g., schizophrenia, bipolar disorder, etc.) judged by the investigator to be unable to comply with study procedures; History of conditions affecting gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, severe diabetic gastroparesis, etc.), long-term use of drugs directly affecting gastrointestinal motility, severe gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, etc.), or prior gastrointestinal surgery (except surgeries with no significant effect on gastrointestinal motility, such as gastrointestinal polypectomy, appendectomy, and hemorrhoid surgery); Severe infection, severe trauma, or major or moderate surgery within 1 month before screening; Severe ECG abnormalities at screening (e.g., QTcF \>450 ms, supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), or poorly controlled blood pressure: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Additional laboratory criteria: alkaline phosphatase (ALP) ≥2×ULN; calcitonin ≥50 ng/L; thyroid-stimulating hormone (TSH) \<0.4 or \>6.0 mIU/L; hemoglobin \<100 g/L; Presence of acute or chronic hepatitis, or history of other severe liver diseases except metabolic-associated fatty liver disease; presence of significant hematologic diseases (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or diseases causing hemolysis/red blood cell instability; presence of autoimmune disease with planned systemic glucocorticoid or immunosuppressant therapy during the study; prior organ or bone marrow transplantation or planned transplantation during the trial; Known or suspected history of excessive alcohol consumption (weekly ethanol intake ≥210 g for men and ≥140 g for women for \>3 months), or history of drug abuse or illicit drug use; Any other condition that, in the investigator's opinion, may affect compliance or safety assessment.

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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

    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

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

    Wuhan, Hubei, 430030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.