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39 Fatty Liver Disease Trials
Power is an online platform that helps thousands of Fatty Liver Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Milk Thistle for Pediatric Fatty Liver Disease
Cleveland, OhioPediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:9 - 22
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disorders, Malignancy, Transplantation, Immunologic Diseases, Others
20 Participants Needed
Survodutide for Fatty Liver Disease
Columbus, OhioThis 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 in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Hepatitis B, Hepatitis C, Others
1590 Participants Needed
SMOFlipid for Malnutrition
Pittsburgh, PennsylvaniaEvaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:1 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Hyperlipidemia, Cardiopulmonary Instability, Liver Conditions, Others
Must Be Taking:Parenteral Nutrition
100 Participants Needed
Survodutide for Fatty Liver Disease
Columbus, OhioThis study is open to adults who are at least 18 years old 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 this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.
This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Liver Cirrhosis, Hepatocellular Carcinoma, Others
Must Not Be Taking:Obesity Medications
1800 Participants Needed
Efruxifermin for Fatty Liver Disease
Springboro, OhioThis is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Type 1 Diabetes, Others
1150 Participants Needed
Efinopegdutide for Fatty Liver Disease
Ypsilanti, MichiganResearchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn:
* If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver
* About the safety of efinopegdutide and how well people tolerate it
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Hepatitis, Type 1 Diabetes, Heart Problems, Others
80 Participants Needed
Metabolic Surgery for Non-Alcoholic Fatty Liver Disease
Cleveland, OhioMetabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.
Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Type 1 Diabetes, HIV, Others
Must Not Be Taking:Semaglutide, Tirzepatide, Liraglutide, Others
120 Participants Needed
DD01 for Fatty Liver Disease
Columbus, OhioThis is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
68 Participants Needed
Pegozafermin for Liver Cirrhosis
Columbus, OhioThe study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Liver Disorder, Hepatic Decompensation, Hepatocellular Carcinoma, Diabetes, Others
762 Participants Needed
Survodutide for Obesity and Fatty Liver Disease
Dayton, OhioThis study is open to adults who are at least 18 years old and have
* presumed or confirmed NASH together with overweight or obesity and
* a body mass index (BMI) of 30 kg/m² or more, or
* a BMI of 27 kg/m² and at least one weight-related health problem.
People with a history of other chronic liver diseases cannot take part in this study.
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
187 Participants Needed
Pegozafermin for Fatty Liver Disease
Dayton, OhioThe study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Cirrhosis, Diabetes, Others
1050 Participants Needed
GSK4532990 for Fatty Liver Disease
Indianapolis, IndianaThe purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Cirrhosis, Unstable Liver Disease, Others
56 Participants Needed
Soy Milk for Non-alcoholic Fatty Liver Disease
Cincinnati, OhioA randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:5 - 12
Sex:All
Key Eligibility Criteria
Disqualifiers:Soy Allergy, Cow's Milk Allergy, Recent Antibiotics, Endocrine Disorders, Others
44 Participants Needed
Efruxifermin for NASH
Columbus, OhioThis trial is testing a medication called efruxifermin (EFX) to see if it can help people with a specific liver condition called non-cirrhotic NASH/MASH. The patients have significant liver damage but not cirrhosis. EFX aims to improve liver health by reducing swelling and scarring in the liver.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Cirrhosis, Type 1 Diabetes, Others
1650 Participants Needed
Efruxifermin for NASH
Columbus, OhioThis trial is testing a medication called efruxifermin (EFX) to see if it can help people with specific liver conditions. These conditions are hard to treat with current methods. EFX aims to improve liver health by reducing inflammation and fat buildup in the liver.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Alcoholic Liver Disease, Autoimmune Disorders, Type 1 Diabetes, Others
700 Participants Needed
Miricorilant for Non-Alcoholic Steatohepatitis
Columbus, OhioThis trial is testing a medication called miricorilant to see if it can help adults with a liver disease called NASH. The medication aims to reduce fat and inflammation in the liver. About 150 patients will take either miricorilant or another treatment for several months.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Cirrhosis, Alcohol Use, Others
195 Participants Needed
Rosuvastatin for Liver Cirrhosis
Cleveland, OhioThis is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Hepatocellular Carcinoma, Portal Thrombosis, Others
Must Not Be Taking:Statins, Amiodarone, Methotrexate, Others
256 Participants Needed
Efinopegdutide for Nonalcoholic Steatohepatitis (NASH)
Cincinnati, OhioThis trial is testing a new medicine called efinopegdutide to see if it can help people with a liver disease called non-alcoholic steatohepatitis (NASH). Researchers want to find out if this medicine can reduce the symptoms of NASH without making liver scarring worse. They are also checking how safe the medicine is and how well people can tolerate it.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 80
Sex:All
360 Participants Needed
AZD2693 for Non-alcoholic Steatohepatitis with Fibrosis
Westlake, OhioThis trial is testing a new medication called AZD2693, which is given as an injection under the skin. It is aimed at adults with a specific liver condition and a certain genetic marker. The goal is to see if it can reduce liver damage and improve liver function.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
220 Participants Needed
ALN-HSD for NASH with Fibrosis
Indianapolis, IndianaThis trial is testing a new drug called ALN-HSD to help people with a liver disease called NASH. NASH causes fat to build up in the liver, leading to damage and scarring. The drug aims to reduce this damage and improve liver health.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Liver Disease, Substance Abuse, Diabetes, Bariatric Surgery, Others
120 Participants Needed
GSK4532990 for NASH
Springboro, OhioThis trial is testing a new drug called GSK4532990 to see if it can help people with severe liver damage caused by NASH. The drug aims to reduce liver scarring and swelling. The study will last over a year, with about a year of treatment.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
271 Participants Needed
HTD1801 for Non-alcoholic Fatty Liver Disease
Westlake, OhioThis trial is testing HTD1801, a medication, to see if it can help adults with NASH and liver fibrosis who also have type 2 diabetes or pre-diabetes. The goal is to see if the medication can reduce liver inflammation and scarring, thereby improving liver health.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
218 Participants Needed
K-877-ER + CSG452 for NASH
Dayton, OhioThis trial is testing two new experimental drugs used together to treat adults with a serious liver disease. The combination is expected to be more effective than using each drug alone.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Other Liver Diseases, Alcohol Use, Others
200 Participants Needed
Rencofilstat for NASH with Advanced Liver Fibrosis
South Bend, IndianaThis trial tests Rencofilstat, a medication that may improve liver damage, in adults with NASH and significant liver fibrosis. The drug works by reducing liver scarring and damage.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
120 Participants Needed
Vitamin E for Non-alcoholic Fatty Liver Disease
Cleveland, OhioThis is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
200 Participants Needed
LY3849891 for Non-alcoholic Fatty Liver Disease
Indianapolis, IndianaThis trial is testing a new medication called LY3849891 in people with fatty liver disease who have a specific genetic variant. The study will check how the drug affects liver fat and how the body processes it using blood tests and imaging.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Alcohol Abuse, Cirrhosis, Heart Attack, Cancer, Others
176 Participants Needed
Dietary Oils for Fatty Liver Disease
Columbus, OhioThe research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22 - 80
Sex:All
74 Participants Needed
NNC0194-0499 + Semaglutide for Fatty Liver Disease
Columbus, OhioThis trial is testing if combining two medicines, NNC0194-0499 and semaglutide, can reduce liver damage in people with non-alcoholic steatohepatitis (NASH). Semaglutide, already used for diabetes and weight loss, and NNC0194-0499 work differently but may be more effective together. Another combination being tested includes semaglutide and NNC0174-0833. Participants will receive regular injections and undergo liver biopsies to measure the treatment's effectiveness.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
698 Participants Needed
Lanifibranor for Nonalcoholic Steatohepatitis (NASH)
Columbus, OhioThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Chronic Liver Disease, Cirrhosis, HIV, Others
Must Be Taking:GLP1 Receptor Agonists, SGLT2 Inhibitors
1000 Participants Needed
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
180 Participants Needed
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Frequently Asked Questions
How much do Fatty Liver Disease clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Fatty Liver Disease clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Fatty Liver Disease trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Fatty Liver Disease is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Fatty Liver Disease medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Fatty Liver Disease clinical trials ?
Most recently, we added Milk Thistle for Pediatric Fatty Liver Disease, Survodutide for Fatty Liver Disease and SMOFlipid for Malnutrition to the Power online platform.
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