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Life sciences · Interventional Study
ClinicalTrials.gov · September 18, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07803705). This is a study registration, not published results. Lead sponsor: Tongji Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 194 participants (ESTIMATED). Conditions: Fatty Pancreas, Overweight, Obesity. Interventions: DRUG: mazdutide; OTHER: Placebo matching mazdutide. Primary outcome measures: Percentage change in Intrapancreatic Fat Deposition (IPFD) from baseline , From baseline to Week 48. Brief 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.