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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Orlistat; Drug: Liraglutide

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: GU Yunjuan, doctor; Phone Number: 86 15851207860; Email: desette@ntu.edu.cn
• Study Contact Backup: Name: XIA Jie, master; Phone Number: 86 19502555209; Email: desette@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: GU Yunjuan, doctor; Phone Number: 15851207860; Email: desette@ntu.edu.cn
      • Contact: XIA JACK, Master; Phone Number: 19502555209; Email: 2465731173@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lifestyle intervention + orlistat group; The control group was treated with lifestyle intervention + orlistat until the end of follow-up.	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.
Experimental: lifestyle intervention + liraglutide group; Trial group 1 was treated with lifestyle intervention + liraglutide.	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.
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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight	Three months
FABP4	fatty acid-binding protein-4	Three months
BMI	body mass index	Three months
lipid indices	TC, TG, HDL-C, LDL-C	Three months
LSM	liver stiffness measurement	Three months
CAP	Controlled attenuation parameters	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference,	Waist circumference	Three months
hip circumference	hip circumference	Three months

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Collaborators: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
• Investigators: Study Director: GU Yunjuan, doctor, Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Liver Diseases; Obesity; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Lipid Regulating Agents; Anti-Obesity Agents; Incretins; Glucagon-Like Peptide-1 Receptor Agonists; Liraglutide; Orlistat
• Other Study ID Numbers: liraglutide

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No