drugset / Trial / NCT07803705

Efficacy of Mazdutide on Fatty Pancreas

NCT07803705 ↗

Not yet recruiting 194 enrolled Tongji Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2026-11-15
Primary completion
2028-06-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mazdutide Protein / enzyme biologic 4 mg Subcutaneous
Subject Mazdutide Protein / enzyme biologic 6 mg Subcutaneous