Clinical trial NCT06501326: Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
Official title: Clinical Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism-associated Fatty Liver Disease (MAFLD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Non-alcoholic Fatty Liver Disease
Obesity
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
First posted: 2024-07-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. Randomization Patients were divided into three groups by lifestyle intervention + orlistat treatment, in lifestyle intervention + liraglutide treatment and in lifestyle intervention + orlistat + liraglutide treatment, and eligible patients were randomized into trial group 1,2 and control group strictly according to the random number method. The ratio of test group 1,2 and control group was 1:1:1.
2. Name and specification of the intervention / study medication Use: liraglutide injection, 3ml: 18mg (prefilled pen) and orlistat capsules.
3. Study the intervention program All subjects were treated with 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 1500 to 1800 kcal per day and women followed a diet of 1200 to 1500 kcal per day. All three groups of diets included 40% to 55% carbohydrates, 15% to 20% protein and 20% to 30% fat.During the 3-month trial period, conduct at least 150 minutes of moderate intensity exercise per week, with exercise energy consumption of 1500 kcal / week or more.Other drugs containing the same ingredients of orlistat and liraglutide were prohibited during the trial.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 plus liraglutide.Trial Group 2 was treated with lifestyle intervention plus liraglutide plus orlistat.Medication regimen: Patients in the test or control groups were treated with liraglutide or (and) orlistat for 3 months from the first day after enrollment. The starting dose of liraglutide was 0.6mg per day, gradually increased to 1.2mg per day after one week, and continued to 1.8mg per day when tolerated. Patients taking orlistat should take 120mg orlistat capsules every day or one hour after a meal, and if one meal is not eaten or the food is not fat, they can be omitted.
4. Efficacy evaluation index (primary efficacy index and secondary efficacy index) glycosylated hemoglobin, FABP 4, body weight, waist circumference, hip circumference, BMI, and lipid index: TC, TG, HDL-C, LDL-C; Liver fibrosis index: liver hardness, liver fat attenuation (fibro scan detection instrument), body fat volume, visceral fat area (inbody body meter), liver function index: balanced and comparable analysis of ALT and AST before the treatment of the three groups of (1); (2) the change of each level before and after treatment, Test of their respective efficacy; (3) The difference between the three groups after treatment and the difference between the groups and the three groups.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Metabolic Associated Fatty Liver Disease(MAFLD);
2. Clinical diagnosis of Obesity.

Exclusion Criteria:

1. Medicated Hepatitis and Viral Hepatitis;
2. Have severe hepatic or renal insufficiency;
3. have used any weight-loss drug;
4. History of severe gastrointestinal disorders;
5. Malignant tumors, autoimmune diseases, hematologic diseases;
6. Psychopath;
7. Women who are pregnant, breastfeeding or preparing for pregnancy;

Primary outcomes:
measure: Body weight
timeFrame: Three months
measure: FABP4
timeFrame: Three months
measure: BMI
timeFrame: Three months
measure: lipid indices
timeFrame: Three months
measure: LSM
timeFrame: Three months
measure: CAP
timeFrame: Three months
Secondary outcomes:
measure: Waist circumference,
timeFrame: Three months
measure: hip circumference
timeFrame: Three months
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: GU Yunjuan, doctor
role: STUDY_DIRECTOR
References: