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

NCT06501326 | Unknown Phase 4 DMC

• 1 other identifier: liraglutide
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Waist circumference,

  Three months

• hip circumference

  Three months

Study Arms (3)

lifestyle intervention + orlistat group

ACTIVE COMPARATOR

The control group was treated with lifestyle intervention + orlistat until the end of follow-up.

Drug: Orlistat

lifestyle intervention + liraglutide group

EXPERIMENTAL

Trial group 1 was treated with lifestyle intervention + liraglutide.

Drug: Liraglutide

lifestyle intervention + liraglutide + orlistat group

EXPERIMENTAL

Trial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months.

Drug: Liraglutide; Drug: Orlistat

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.

lifestyle intervention + liraglutide + orlistat group; lifestyle intervention + liraglutide group

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.

lifestyle intervention + liraglutide + orlistat group; lifestyle intervention + orlistat group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Interventions

Liraglutide; Orlistat

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Lactones; Organic Chemicals

Study Officials

• GU Yunjuan, doctor

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Central Study Contacts

GU Yunjuan, doctor

CONTACT

15851207860; desette@ntu.edu.cn

XIA Jie, master

CONTACT

19502555209; desette@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: July 15, 2024
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: February 28, 2025
• Last Updated: July 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)