Clinical trials: Steatohepatitis, Nonalcoholic
Non-alcoholic Steatohepatitis
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH
- Trial name
- NCT03812029
- Testing
- Vonafexor
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 120 people
- Sponsor
- Enyo Pharma
Nonalcoholic Fatty Liver Disease (NAFLD)
Anti-LPS Antibody Treatment for Pediatric NAFLD
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver…
- Trial name
- NCT03042767
- Testing
- IMM-124E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Miriam Vos, MD
Nonalcoholic Steatohepatitis (NASH)
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NCT03823703
- Testing
- Miricorilant
- Where
- 15 sites in United States
- Volunteers
- 12 people
- Sponsor
- Corcept Therapeutics
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Trial name
- NCT06052566
- Testing
- Efinopegdutide
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver
Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Multicenter, randomized, double-blinded, placebo-controlled clinical trial is focused on novel treatments for non-alcoholic fatty liver disease (NAFLD), the most common cause of chronic liver disease.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver, Non-Alcoholic Steatohepatitis
- Trial name
- PUVENAFLD (NCT04198805)
- Testing
- Vitamin E [(all-rac)-α-tocopheryl acetate], Omega-3 fatty acid (DHA EE), Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate]
- Where
- 15 sites in United States
- Volunteers
- 205 people
- Sponsor
- Naga P. Chalasani
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Nonalcoholic Fatty Liver Disease, HIV
Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy
A subset of patients with NAFLD that have not been extensively studied are those infected with human immunodeficiency virus (HIV). Currently, there is no FDA approved treatment for NAFLD or NASH.
- Trial name
- ARRIVE (NCT02684591)
- Testing
- Aramchol
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek
Nonalcoholic Fatty Liver Disease
The University of Michigan Wellness for Liver Health Study
The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).
- Trial name
- NCT05010070
- Testing
- diet and lifestyle program
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
Nonalcoholic Steatohepatitis
Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for…
- Trial name
- NCT00590161
- Testing
- pentoxifylline (PTX)
- Where
- 3 sites in United States
- Volunteers
- 55 people
- Sponsor
- Case Western Reserve University
Non-alcoholic Steatohepatitis
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy.
- Trial name
- NCT03969719
- Testing
- PF-06835919
- Where
- 106 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Pfizer
NAFLD, Obesity
Vigabatrin and Insulin Sensitivity
Nonalcoholic fatty liver disease (NAFLD) is a common complication of obesity and is associated with an increased risk of developing type 2 diabetes.
- Trial name
- NCT04321395
- Testing
- Vigabatrin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Washington University School of Medicine
Fatty Liver
Insulin Resistance in Non-alcoholic Fatty Liver Disease
The study is designed to investigate the relationship between insulin resistance and non-alcoholic fatty liver disease (NAFLD) and to investigate potential mechanisms underlying insulin resistance in NAFLD by determining…
- Trial name
- NCT01289639
- Testing
- fenofibrate, pioglitazone
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease
Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and…
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease
- Trial name
- NCT06482112
- Testing
- Efinopegdutide
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 124 people
- Sponsor
- Merck Sharp & Dohme LLC
NAFLD, Diabetes Mellitus
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke…
- Trial name
- NAFLD-DM (NCT05844137)
- Testing
- NAFLD Education, diet/lifestyle support, T2D medication management
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Duke University
Fatty Liver Disease, Nonalcoholic
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons.
- Trial name
- NCT00596934
- Testing
- metreleptin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Elif Oral
Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests
- Trial name
- NAFLD (NCT02077374)
- Testing
- IDN-6556
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-Alcoholic Steatohepatitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
- Trial name
- NCT03421431
- Testing
- EDP-305 Dose 1, EDP-305 Dose 2
- Where
- 82 sites in United States, Canada and 4 more
- Volunteers
- 134 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-alcoholic Steatohepatitis
Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects…
- Trial name
- SyNCH (NCT00680407)
- Testing
- Silymarin 700 mg, Silymarin 420 mg
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- Madaus Inc
Fatty Liver, Nutritional and Metabolic Disease
Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with…
- Trial name
- LGI-NAFLD (NCT04415632)
- Testing
- low glycemic index diet, High glycemic index diet
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University of Nottingham