Clinical trials: Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Diabetes Mellitus, Type 2, NAFLD
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity.
- Conditions
- Diabetes Mellitus, Type 2, NAFLD, NASH
- Trial name
- L-FibroT2DM (NCT04232293)
- Testing
- Blood tests
- Where
- 2 sites in France
- Volunteers
- 722 people
- Sponsor
- Nantes University Hospital
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Chronic Liver Disease
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death.
- Trial name
- FALL (NCT05335603)
- Where
- Denmark
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Non-Alcoholic Fatty Liver Disease
Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease
Many studies suggest that Porphyromonas gingivalis, a virulent periodontopathogenic bacterium, is associated with many systemic diseases such as cardiovascular diseases.
- Trial name
- BUCCONAFLD (NCT05654129)
- Testing
- saliva samples, medical questionnaire
- Where
- France
- Volunteers
- 182 people
- Sponsor
- University Hospital, Toulouse
Non-Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages…
- Trial name
- NCT02466516
- Testing
- SEL, SIM
- Where
- 28 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Nonalcoholic Steatohepatitis, Fibrosis
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
- Trial name
- NASH (NCT05011305)
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 129 sites in United States, Argentina and 2 more
- Volunteers
- 189 people
- Sponsor
- Zydus Therapeutics Inc.
Fatty Liver, Nonalcoholic Steatohepatitis
Treatment of Nonalcoholic Steatohepatitis With Pioglitazone
This study will evaluate the effectiveness of pioglitazone, a new diabetes medicine, on decreasing insulin resistance and improving liver disease in patients with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT00013598
- Testing
- Pioglitazone
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Non-alcoholic Steatohepatitis (NASH)
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and…
- Trial name
- NCT04771273
- Testing
- Survodutide
- Where
- 154 sites in United States, Australia and 23 more
- Volunteers
- 295 people
- Sponsor
- Boehringer Ingelheim
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
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 biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Liver Fat, Liver Fibrosis
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD
Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease…
- Conditions
- Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes
- Trial name
- Ertu-NASH (NCT05644717)
- Testing
- Ertugliflozin 5 mg, 15mg
- Where
- Pakistan
- Volunteers
- 164 people
- Sponsor
- Getz Pharma
Nonalcoholic Steatohepatitis
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
- Trial name
- AURORA (NCT03028740)
- Testing
- Cenicriviroc
- Where
- 346 sites in United States, Australia and 26 more
- Volunteers
- 1,778 people
- Sponsor
- Tobira Therapeutics, Inc.
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Non Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis…
- Trial name
- NCT04880187
- Testing
- AXA1125
- Where
- 75 sites in United States, Australia and 5 more
- Volunteers
- 273 people
- Sponsor
- Axcella Health, Inc
NASH, NAFLD
Digoxin In NASH (CODIN)
Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans.
- Conditions
- NASH, NAFLD, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Mash
- Trial name
- CODIN (NCT06588699)
- Testing
- Digoxin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Yale University
Hepatitis B, Chronic
Relationship Between MAFLD and Liver Fibrosis Progression in Patients With Chronic Hepatitis B: a Multicenter Retrospective Cohort Study
This multicenter retrospective study aims to study the association between the presence of MAFLD and change in liver stiffness over time in untreated and treated patients with chronic hepatitis B
- Trial name
- MAFLD-HBV 1 (NCT05708560)
- Where
- 3 sites in Netherlands
- Volunteers
- 800 people
- Sponsor
- Erasmus Medical Center
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or…
- Trial name
- MAESTRO-NASH (NCT03900429)
- Testing
- MGL-3196, Liver Biopsy
- Where
- 247 sites in United States, Australia and 14 more
- Volunteers
- 1,759 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
NAFLD, Obesity
Biomarkers in the Diagnosis and Prognosis of NAFLD
Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage.
- Conditions
- NAFLD, Obesity, Liver Fibrosis, Diabetes Mellitus, Type 2
- Trial name
- NCT06098417
- Testing
- Plasma Test, Liver biopsy, Visceral adipose tissue biopsy
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- University of Trieste
NAFLD, NASH With Fibrosis
Dasatinib and Quercetin to Treat Fibrotic Non-alcoholic Fatty Liver Disease
To examine the effect of dasatinib plus quercetin on liver fibrosis in individuals with biopsy proven NAFLD with fibrosis by performing a double-blind randomized controlled proof-of-principle study
- Conditions
- NAFLD, NASH With Fibrosis, Liver Fibrosis
- Trial name
- NCT05506488
- Testing
- Dasatinib 100 MG + Quercetin (1000 MG)
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)