Clinical Trials for Fatty Liver Disease

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Fatty Liver Disease from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 22
• Active, not recruiting: 8
• Completed: 11
• Other: 9

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03884075 — Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)

Background:

In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.

Objective:

To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.

Eligibility:

People with NAFLD and healthy volu…

NCT07662356 — Clinical Course and Biomarkers Associated With Nonalcoholic Fatty Liver Disease (NAFLD) in Chinese Patients With Obesity

Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in many parts of the world. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and result in cirrhosis and liver cancer. Despite NAFLD is common, there are a lot of knowledge gaps about this common disease including the progression from NAFLD to NASH and from fibrosis to cirrhosis, efficacious treat…

NCT03481829 — Early Tracking of Childhood Health Determinants (ETCHED) Study

Background:

Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during…

NCT05519475 — A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

This study is researching an investigational drug, ALN-HSD called “study drug”. This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis …

NCT05699018 — Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients

The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.

NCT06215716 — A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).

The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

NCT06318169 — A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

NCT06419374 — A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

NCT06096779 — A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis

The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-pugh B7 or B8 cirrhosis.

NCT06632444 — LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

This study is open to adults who are at least 18 years old living with obesity and have:

• a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and
• moderate or advanced liver fibrosis

People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of th…

NCT06632457 — LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

This study is open to adults who are at least 18 years old and have:

• A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
• A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
• BMI of 27 kg/m2 or more or
• 25 kg/m2 or more if the participant is Asian.

People with a history of other chronic liver diseases or high alcohol intake cannot take part i…

NCT06920043 — A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

NCT06836609 — A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

This study is researching an experimental drug called ALN-CIDEB, also referred to as “study drug”. The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver.

The aim of the stu…

NCT06138821 — Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated …

NCT06824974 — Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer

This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and/or hepatocellular carcinoma (HCC). Eligible individuals who…

NCT07165028 — A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be random…

NCT07288138 — A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)

The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.

NCT07679542 — Dihydroartemisinin for MAFLD

Brief Summary

Purpose:

This is a proof-of-concept clinical trial to evaluate whether Dihydroartemisinin (DHA), a medication commonly used to treat malaria, can effectively reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). The study will also rigorously assess the safety and tolerability of DHA in this specific patient population.

Study Design:

This is a singl…

NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD

This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver…

NCT07378072 — Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity

The objective of this study is to demonstrate that an < or equal to 8-hour time-restricted eating (i.e., fasting for at least 16 hours every day), not focusing on reducing caloric intake, reduces intra-hepatic fat in patients with obesity and Metabolic dysfunction-Associated Steatotic liver Disease (MASLD).

NCT06843148 — Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.

Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver.

The goal of this mechanistic study is to investigate metabolic response in patients aged 20 to 80 years with …

NCT07403604 — Effect of Insulin Lowering on Lipogenesis

The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg/kg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contribu…

Active, Not Recruiting

NCT04505436 — Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH

NCT04822181 — Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.

Participants will need to inject themselves with medicine under the skin. Participants will need to do th…

NCT04849728 — A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

NCT05500222 — A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.

NCT05583344 — Phase 2b Study of GSK4532990 in Adults With NASH

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

NCT06151964 — A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight

AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its associated co-morbidities. Co-administration of AZD9550 and AZD6234 is currently being evaluated in participants living with obesity and overweight without T2DM in an ongoing …

NCT06366425 — Screening for Chronic Liver Diseases in General Population

Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

NCT07024212 — Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II clinical trial that consists of two parts. The primary objective of Part 1 is to assess the preliminary efficacy of DR10624 Injection in MASLD subjects at high risk of liver fibrosis. The secondary objectives are to assess the safety and tolerability, PK profiles, and immunogenicity of DR10624 Injectio…

Not Yet Recruiting

NCT07632222 — High-Protein Diet for Improving Alcoholic Fatty Liver Disease

Alcohol-associated liver disease (ALD) is a major cause of mortality from malignant liver diseases, accounting for 47.9% of cirrhosis-related deaths and 30% of liver cancer-related deaths annually. In China, both alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant health concern for the population. Alcohol-associated fatty …

NCT07685353 — Influence of Donor and Recipient Genetic Polymorphisms on Graft Steatosis After Liver Transplant

MASH (Metabolic Dysfunction-associated Steatohepatitis) is among the most common indications for liver transplantation.The metabolic syndrome persists after liver transplant and is often further exacerbated among MAFLD patients, thereby leading to recurrence of MAFLD in the allograft. MAFLD is a complex phenotype, dynamic interactions between both genetic and environmental factors are likely to…

NCT07376226 — Effects of Whole Fruit on Blood Sugar in People With Type 2 Diabetes

This study will determine the effects of consuming whole fruit on blood sugar control, liver fat, and cardiovascular health in adults with type 2 diabetes who are not treated with insulin.

NCT07376486 — Duodenal pulsENDO as an Early Treatment for Type 2 DM

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

NCT07684248 — Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a mi…

Enrolling by Invitation

NCT07662902 — Ulcerative Colitis Permeability

Study aim: To investigate whether the values of zonulin and lipopolysaccharide-binding protein (LBP) as biomarkers of intestinal permeability are related to the degree of liver steatosis, steatohepatitis and fibrosis in patients with ulcerative colitis (UC) and metabolic-associated steatotic liver disease (MASLD).

Subjects and methods: Participants with UC will be included, except for those wh…

Completed Trials

NCT02520609 — Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease

Background:

Metabolism refers to the many chemical pathways by which various compounds, including food, are processed and used in the body. People with non-alcoholic fatty liver disease (NAFLD) have too much fat in their liver cells, but what causes it is unclear. One explanation is that people with NAFLD process food and metabolize it differently than people without NAFLD. Researchers want to…

NCT03849235 — A Pathophysiological Study of the Postprandial Human Liver (PLS)

Fatty liver disease is a globally widespread disease. The identification of valid biomarkers and targets for potential treatments requires in-depth knowledge about the pathophysiology of the postprandial liver. The study will consist of seven work packages (WP) including blood tests and liver biopsies taken after fasting or ingestion of a standardized meal in: healthy controls (WP 1), patients …

NCT04639414 — Combined Active Treatment in Type 2 Diabetes With NASH

The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with…

NCT04880031 — A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension

This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension. It includes Parts A, B, C and D.

NCT05395481 — A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on M…

NCT05327127 — Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

NCT05804422 — Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study)

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by MRI-PDFF and ultrasonography, liver stiffness (LS) measured by Shear Wave Elastography (SWE) and anthropomorphic variables in NAFLD patients.

The study will include 3 periods. Screening period of up to 1 weeks to asse…

NCT06168383 — To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .

A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis.

NCT06352697 — Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study)

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD patients.

The study will include 3 periods. Screening period of up to 1 weeks to a…

NCT06627114 — Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients

The aim of this clinical trial is to examine the impact of nutritional education and omega-3 supplementation in influencing body weight, liver enzyme levels, and lipid profiles in patients diagnosed with non-alcoholic fatty liver disease.

Eligible patients who have non-alcoholic fatty liver disease are randomized to receive either nutritional education, omega-3 fatty acids containing DHA and E…

NCT07663682 — Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD

This observational study aims to investigate the relationship between serum nociceptin levels and sympathetic nervous system activity in patients with both type 2 diabetes mellitus (T2DM) and metabolic associated fatty liver disease (MAFLD). A total of 100 participants, aged 18 to 75 years, who are scheduled for laparoscopic cholecystectomy at our hospital will be enrolled. Participants will be…

Other (Suspended)

NCT02506946 — NAFLD in Adolescents and Young Adults With PCOS

This project focuses on an at-risk adolescent and young adult population who may gain long-term health benefits from detection of risk factors at a young age. The primary aims of this proposal are: 1) To observe whether adolescents and young adults with Polycystic Ovary Syndrome (PCOS) are more likely to have elevated liver fat (>/=4.8%) than controls by studying liver fat deposition measured …

Other (Withdrawn)

NCT03302481 — Mitochondrial Metabolism and Hepatic Complications of Obesity

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.

Other (Terminated)

NCT04365868 — Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.