Clinical Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism-associated Fatty Liver Disease (MAFLD)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

STUDY OBJECTIVE: To explore the clinical efficacy and safety of liraglutide in obesity combined with metabolism-associated fatty liver disease (MAFLD). INTERVENTION PROGRAM: All subjects underwent dietary control and exercise therapy, and controlled smoking and alcohol consumption. During the 3 months of the trial, men were instructed to follow a diet of 1,500 to 1,800 kcal per day and women followed a diet of 1,200 to 1,500 kcal per day. All three diets included 40 to 55 percent carbohydrates, 15 to 20 percent protein and 20 to 30 percent fat. During the 3-month trial period, subjects performed at least 150 minutes of moderate-intensity exercise per week with an energy expenditure of 1500 kcal/week or more. Other medications containing the same ingredients as orlistat and liraglutide were prohibited during the trial period. After randomization, the control group was treated with lifestyle intervention + orlistat until the end of follow-up. Trial group 1 was treated with lifestyle intervention + liraglutide. Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Clinical diagnosis of Metabolic Associated Fatty Liver Disease(MAFLD);

• Clinical diagnosis of Obesity.

Locations
Other Locations
China
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
GU Yunjuan, doctor
desette@ntu.edu.cn
15851207860
Backup
XIA Jie, master
desette@ntu.edu.cn
19502555209
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 102
Treatments
Active_comparator: lifestyle intervention + orlistat group
The control group was treated with lifestyle intervention + orlistat until the end of follow-up.
Experimental: lifestyle intervention + liraglutide group
Trial group 1 was treated with lifestyle intervention + liraglutide.
Experimental: lifestyle intervention + liraglutide + orlistat group
Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months.
Sponsors
Collaborators: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov