Non-alcoholic Fatty Liver DiseasePhase 4NCT06501326
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver Disease
A Phase 4 study testing Liraglutide and Orlistat in people with Non-alcoholic Fatty Liver Disease and Obesity, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Liraglutide and Orlistat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 28 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Metabolic Associated Fatty Liver Disease(MAFLD);
- Clinical diagnosis of Obesity.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
GU Yunjuan, doctor, 15851207860, desette@ntu.edu.cn
XIA JACK, Master, 19502555209, 2465731173@qq.com
About this study
Official title: 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.
Read the detailed description
- 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.
- Name and specification of the intervention / study medication Use: liraglutide injection, 3ml: 18mg (prefilled pen) and orlistat capsules.
- 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.
- 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.
- Conditions
- Non-alcoholic Fatty Liver Disease, Obesity
- Being tested
- Liraglutide, Orlistat
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
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.
OrlistatDrug
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 group | Role | What they receive |
|---|---|---|
| lifestyle intervention + orlistat group | Active comparator | The control group was treated with lifestyle intervention + orlistat until the end of follow-up. Receives: Drug: Orlistat |
| lifestyle intervention + liraglutide group | Experimental | Trial group 1 was treated with lifestyle intervention + liraglutide. Receives: 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. Receives: Drug: Liraglutide; Drug: Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight
Measured: Three months
FABP4
fatty acid-binding protein-4
Measured: Three months
BMI
body mass index
Measured: Three months
lipid indices
TC, TG, HDL-C, LDL-C
Measured: Three months
LSM
liver stiffness measurement
Measured: Three months
CAP
Controlled attenuation parameters
Measured: Three months
Secondary outcomes (2)
Waist circumference,
Waist circumference
Measured: Three months
hip circumference
hip circumference
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- GU Yunjuan, doctor, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501326
- Sponsor's protocol ID
- liraglutide
- Status last verified
- Nov 2023
- First submitted
- 26 Dec 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism-associated Fatty Liver Disease (MAFLD)
- ClinicalTrials.gov ID
- NCT06501326
- Acronym / sponsor ID
- liraglutide
- Conditions
- Non-alcoholic Fatty Liver Disease, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Name and specification of the intervention / study medication Use: liraglutide injection, 3ml: 18mg (prefilled pen) and orlistat capsules.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention + orlistat group | Active comparator | Drug: OrlistatThe control group was treated with lifestyle intervention + orlistat until the end of follow-up. |
| lifestyle intervention + liraglutide group | Experimental | Drug: LiraglutideTrial group 1 was treated with lifestyle intervention + liraglutide. |
| lifestyle intervention + liraglutide + orlistat group | Experimental | Drug: Liraglutide, Drug: OrlistatTrial group 2 was treated with lifestyle intervention + liraglutide + orlistat for a total treatment and follow-up period of 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Metabolic Associated Fatty Liver Disease(MAFLD);
- Clinical diagnosis of Obesity.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAfter 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 | lifestyle intervention + liraglutide + orlistat group, lifestyle intervention + liraglutide group |
| OrlistatAfter 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 | lifestyle intervention + liraglutide + orlistat group, lifestyle intervention + orlistat group |
Primary outcome
Body weight
Time frame: Three months
Body weight
FABP4
Time frame: Three months
fatty acid-binding protein-4
BMI
Time frame: Three months
body mass index
lipid indices
Time frame: Three months
TC, TG, HDL-C, LDL-C
LSM
Time frame: Three months
liver stiffness measurement
CAP
Time frame: Three months
Controlled attenuation parameters
2 secondary outcomes
Waist circumference,
Time frame: Three months
hip circumference
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GU Yunjuan, doctor study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Orlistat in people with Non-alcoholic Fatty Liver Disease and Obesity, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GU Yunjuan, doctor (15851207860 ext. 86, desette@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Three months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.