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NOT YET RECRUITING
NCT07803705
NA

Efficacy of Mazdutide on Fatty Pancreas

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of Mazdutide on Fatty Pancreas in Overweight or Obese Adults: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2026-11-15

Completion Date

2028-12-30

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

mazdutide

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.

OTHER

Placebo matching mazdutide

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.

Locations (1)

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

Wuhan, Hubei, China