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

Sponsor
Affiliated Hospital of Nantong University
Study ID
NCT06501326
Phase
PHASE4
Status
Unknown

Conditions

  • Non-alcoholic Fatty Liver Disease
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    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.
  • Orlistat — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Nov 2023
Primary completion
Oct 31, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Body weight [ Time Frame: Three months ]

Central Contacts

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