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

NCTNCT06501326Other idliraglutide

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Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 102 participants (estimated)
Sponsor: Affiliated Hospital of Nantong University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 1 Nov 2023
Primary completion: 31 Oct 2024 (estimated)
Completion: 28 Feb 2025 (estimated)
First posted: 15 Jul 2024
Last update posted: 15 Jul 2024
Conditions: Non-alcoholic Fatty Liver Disease · Obesity

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 4
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
NCT06501326
1 Nov 2023 to est. 28 Feb 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
OrlistatDrug

Arms3

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 outcomes6

Outcomes the sponsor listed as primary.

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

Secondary outcomes(2)

Waist circumference,
Time frame · Three months
Registry description
Waist circumference
hip circumference
Time frame · Three months
Registry description
hip circumference

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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;

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