Opening soonNot applicableInterventional
What this study is about
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center clinical trial designed to evaluate the efficacy and safety of mazdutide in improving fatty pancreas in patients with overweight or obesity. The study plans to enroll 194 participants with overweight or obesity, who will be randomly assigned in a 1:1 ratio to either the mazdutide plus standardized lifestyle intervention group or the placebo plus standardized lifestyle intervention group, for a treatment duration of 48 weeks. The primary efficacy endpoint is the change from baseline in pancreatic proton density fat fraction (PDFF) measured by MRI at week 48. Secondary efficacy endpoints include changes in body weight, body mass index (BMI), waist circumference, glycemic and lipid metabolic parameters, visceral fat, and hepatic fat content. This study aims to provide preliminary evidence-based data supporting the application of mazdutide in the treatment of fatty pancreas associated with metabolic dysfunction.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionFatty Pancreas, Overweight, Obesity
Full registry criteria
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.
Treatments and study arms
mazdutide
Drug
On the basis of standardized lifestyle intervention, patients received mazdutide injection (prefilled auto-injector pen) via weekly subcutaneous injection (abdominal), following a dose-escalation regimen: an initial dose of 2 mg for weeks 1-4, escalation to 4 mg for weeks 5-8, and a maintenance dose of either 4 mg or 6 mg starting from week 9 (determined by tolerability and efficacy), with a treatment duration of 48 weeks.
Placebo matching mazdutide
Other
On the basis of standardized lifestyle intervention, patients received a placebo injection identical to mazdutide injection in appearance, volume, and administration route, via weekly subcutaneous injection (abdominal), with a treatment duration of 48 weeks.