Metabolic Dysfunction-associated Fatty Liver Disease

12

Review clinical trials related to Metabolic Dysfunction-associated Fatty Liver Disease. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD

This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Participants needed: 10,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUpdated: Jun 8, 2026Locations: 22
Eligibility criteria

Adults aged ≥18 years, with no restrictions on sex; [+1]

Presence of unhealed wounds, scars, or other conditions in the right upper abdom... [+8]

Status: Not yet recruiting

An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines With Metabolic Dysfunction-associated Fatty Liver Disease

Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Zhujiang HospitalUpdated: Mar 6, 2026Locations: 1
Eligibility criteria

1.Healthy individuals without a history of liver disease or related underlying d...

1. History of severe organic diseases in the liver, gastrointestinal tract, kidn...

Status: Not yet recruiting

Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease

The purpose of this research study is to determine whether taking glycine, a naturally occurring amino acid, as a supplement improves liver health measurements in individuals with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD). This project will be divided into two parts. The first part will be a case-control study comparing parameters of glycine-dependent metabolic pathways between individuals with MASLD and healthy controls. The second part will be a randomized placebo-controlled trial (RCT) to evaluate the impact of 26-week dietary glycine supplementation on parameters of liver health versus 26-week placebo in patients with MASLD.

Participants needed: 60
Trial details
Age: 21-70Biological sex: AllType: InterventionalSponsor: Singapore General HospitalUpdated: Dec 16, 2025
Eligibility criteria

Age 21-70 years [+7]

Uncontrolled diabetes (HbA1c > 8%) [+17]

Status: Not yet recruiting

CPET-based HIIT for MAFLD

High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols. Based on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.

Participants needed: 54
Trial details
Age: 35-65Biological sex: AllType: InterventionalSponsor: Tang YidaUpdated: Sep 17, 2025Locations: 5
Eligibility criteria

Overweight or Obesity: ≥ 24kg/m2,or waist circumference ≥ 90 cm in men and > 85... [+4]

Contraindications for Cardiopulmonary Exercise Testing [+7]

Status: Not yet recruiting

Efficacy and Safety of Calculus Bovis Sativus in Adults With MAFLD

Metabolic dysfunction-associated fatty liver disease (MAFLD) has become the most common chronic liver disease worldwide. Timely therapeutic intervention for MAFLD is crucial for improving patient prognosis and preventing its progression to liver fibrosis, cirrhosis, and even hepatocellular carcinoma (HCC). Therefore, the discovery of novel drugs for the treatment of MAFLD is of great significance. Previous clinical studies have shown that calculus bovis sativus, as an adjuvant therapy for icteric hepatitis and chronic hepatitis B, exhibits significant anti-inflammatory and enzyme-reducing effects, improves liver function indicators, and enhances overall clinical outcomes. However, there is currently no clinical research on the therapeutic effects of calculus bovis sativus in patients with MAFLD, and its underlying mechanisms of action remain to be elucidated. This study proposes a randomized, double-blind, placebo-controlled trial to investigate the effects of calculus bovis sativus in adult patients with MAFLD. The primary objective is to preliminarily explore the clinical efficacy of calculus bovis sativus in treating MAFLD, particularly its impact on liver injury and inflammation. Furthermore, this research will employ a multi-omics approach, integrating metagenomics and metabolomics, to analyze the effects of calculus bovis sativus on the gut microbiota and their metabolites in MAFLD patients. The aim is to uncover its potential mechanisms of action, thereby facilitating its clinical translation and application, and ultimately providing a new therapeutic strategy for patients with MAFLD.

Participants needed: 40
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Huazhong University of Science and TechnologyUpdated: Jul 25, 2025Locations: 1
Eligibility criteria

Has signed the informed consent form (ICF) prior to the study and is fully aware... [+11]

Presence of the following chronic diseases: viral hepatitis; positive serology f... [+21]

Status: Recruiting

An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD. In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.

Participants needed: 337
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai East HospitalUpdated: Apr 23, 2025Locations: 1
Eligibility criteria

Subjects aged over 18 years (including borderline values), of either sex. [+2]

Subjects with incomplete clinical data; [+2]

Status: Recruiting

Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study

The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD). The main question\[s\] it aims to answer are: \[question 1\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \[question 2\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?

Participants needed: 7,000
Trial details
Age: 18-90Biological sex: AllType: ObservationalSponsor: Chongqing Medical UniversityUpdated: Feb 12, 2025Locations: 1
Eligibility criteria

Total participants from NHANES 2017-2020 [+10]

Liver ultrasound data not available [+3]

Status: Not yet recruiting

The Efficacy and Safety of Chiglitazar in Patients with MAFLD-related Cirrhosis

A total of 195 adult patients with biopsy-proven or clinically diagnosed metabolic dysfunction-associated with fatty liver disease(MAFLD)-related cirrhosis will be randomly divided into two arms. One arm will receive Chiglitazar(64 mg) treatment, while the other arm will receive placebo treatment, lasting for 72 weeks. Both the researchers and the participants will be blinded. The primary outcome is the reversal rate of cirrhosis assessed by magnetic resonance elastography. Secondary outcomes include outcome events, changes in histopathological fibrosis stage, non-invasive fibrosis tests, glucose and lipid metabolism indicators.

Participants needed: 195
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: Beijing Friendship HospitalUpdated: Jan 15, 2025Locations: 4
Eligibility criteria

The liver biopsy during the screening period (liver biopsy within 6 months of sc... [+4]

Other chronic liver diseases (including but not limited to viral hepatitis, alco... [+30]

Status: Not yet recruiting

Effect of High Protein Diet on Hepatic Steatosis in Patients With MAFLD

MAFLD is a growing problem in India. Its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. Nutrition is the cornerstone of management. The ideal macronutrient distribution within a hypocaloric diet is not known yet. Evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.

Participants needed: 140
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Institute of Liver and Biliary Sciences, IndiaUpdated: Dec 27, 2024Locations: 1
Eligibility criteria

Newly diagnosed treatment naïve consenting adults with MAFLD (controlled attenua...

• Lean (BMI <23) patients [+6]

Status: Recruiting

Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease

This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Tanta UniversityUpdated: Dec 20, 2024Locations: 1
Eligibility criteria

Age ≥ 18 years. [+2]

History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer,... [+3]

Status: Recruiting

Positive Association of US-FLI With the Severity of CAD

As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.

Participants needed: 190
Trial details
Age: 18-90Biological sex: AllType: ObservationalSponsor: Chongqing Medical UniversityUpdated: Aug 21, 2024Locations: 1
Eligibility criteria

Patients older than 18 years old [+1]

Incomplete clinical data [+6]

Status: Not yet recruiting

Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.

Participants needed: 1,000
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: The Affiliated Hospital of Hangzhou Normal UniversityUpdated: Nov 18, 2023
Eligibility criteria

Age 18-75 years old, gender and ethnicity are not limited; [+3]

Cirrhosis due to any chronic liver disease other than MAFLD (including but not l... [+3]