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

NCT06501326 · Unknown status

Last updated 2026-05-28

This clinical trial tests whether the medication liraglutide helps reduce body weight in adults who have both obesity and metabolism-associated fatty liver disease.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 102 people Planned (estimated).

Who can join Ages 18–70 · all sexes

Timeline Started 2023-11 · est. completion 2025-02

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06501326 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Body weight
Sponsor	Affiliated Hospital of Nantong University
Conditions studied	Non-alcoholic Fatty Liver Disease, Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06501326 ↗