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Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease

NCT06501326 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-07-15

No results posted yet for this study

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.

Conditions

  • Non-alcoholic Fatty Liver Disease
  • Obesity

Interventions

DRUG

Liraglutide

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.

DRUG

Orlistat

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.

Sponsors & Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • GU Yunjuan, doctor · Affiliated Hospital of Nantong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-10-31
Completion
2025-02-28

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501326 on ClinicalTrials.gov