Clinical trials: Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Decompensated Cirrhosis
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new…
- Trial name
- ENCORE-LF (NCT03205345)
- Testing
- Emricasan (25 mg), Emricasan (5 mg)
- Where
- 76 sites in United States
- Volunteers
- 210 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects…
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver, NAFLD
- Trial name
- ASCEND (NCT05402371)
- Testing
- Rencofilstat
- Where
- 41 sites in United States, France and 1 more
- Volunteers
- 120 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
Non-alcoholic Steatohepatitis (NASH), Endoscopic Sleeve Gastroplasty
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with…
- Conditions
- Non-alcoholic Steatohepatitis (NASH), Endoscopic Sleeve Gastroplasty, Non-alcoholic Fatty Liver Disease (NAFLD), Endoscopic Ultrasound
- Trial name
- NCT04820036
- Testing
- Insulin Resistance, Quality of Life Assessment, Liver Function Test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
Nonalcoholic Fatty Liver, Osteoporosis, Postmenopausal
Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode.
- Trial name
- OsteoNAFLD (NCT05493761)
- Testing
- Denosumab, Alendronate Sodium
- Where
- 3 sites in Greece
- Volunteers
- 72 people
- Sponsor
- Aristotle University Of Thessaloniki
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Blood Collection Biorepository for Liver Disease Research
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the…
- Conditions
- Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B, Fibrosis
- Trial name
- NCT03025074
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Prevalence of NAFLD and Advanced Fibrosis in Patients With Type 1 Diabetes
The aim of this study is to assess the prevalence of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes receiving care at Joslin clinic using noninvasive imaging and serum-based methods with the goal of…
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Fibrosis, Liver, Type 1 Diabetes
- Trial name
- NCT04595474
- Testing
- Transient Elastography
- Where
- United States
- Volunteers
- 533 people
- Sponsor
- Joslin Diabetes Center
Vascular Stiffness, Liver Fibroses
Evaluation of the Effect of IHHT on Vascular Stiffness and Elasticity of the Liver Tissue in Patients With MS.
The aim of this study is to assess the effect of interval hypoxy-hyperoxic training (IHHT) on the arterial stiffness and elasticity of the liver tissue in patients with metabolic syndrome and on other components of the metabolic…
- Conditions
- Vascular Stiffness, Liver Fibroses, Metabolic Syndrome, Trimethylamine N-oxyde
- Trial name
- NCT04791397
- Testing
- Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy., Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.
- Where
- Russia
- Volunteers
- 62 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic…
- Trial name
- RESOLVE-IT (NCT02704403)
- Testing
- Elafibranor
- Where
- 326 sites in United States, Argentina and 23 more
- Volunteers
- 2,157 people
- Sponsor
- Genfit
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
Non Alcoholic Fatty Liver Disease
Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.
- Trial name
- NCT01874249
- Testing
- Electronic detailed information, NAFLD Score, Transient elastography
- Where
- Mexico
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Fundación Clínica Médica Sur
Non Alcoholic Steatohepatitis
Comparative Clinical Study Between Empagliflozin Versus Pioglitazone in Non-diabetic Patients With Non-alcoholic Steatohepatitis
This study aims to evaluate the possible beneficial effect of empagliflozin versus pioglitazone on non-diabetic patients with non-alcoholic steatohepatitis (NASH). This study will be a randomized, comparative parallel study.
- Trial name
- NCT05605158
- Testing
- Pioglitazone 30mg, Empagliflozin 10 MG
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Tanta University
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
Fatty Liver, Non-Alcoholic Steatohepatitis
A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic…
- Conditions
- Fatty Liver, Non-Alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses
- Trial name
- Aramchol_005 (NCT02279524)
- Testing
- Aramchol
- Where
- 78 sites in United States, Chile and 9 more
- Volunteers
- 247 people
- Sponsor
- Galmed Research and Development, Ltd.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver…
- Trial name
- NCT07631637
- Testing
- ALN-CIDEB
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Regeneron Pharmaceuticals
HBV, NAFLD
Cost Effective Non Invasive Diagnostic Modalities and Predictive Model for Development and Progression of Fibrosis Among Patients With Hepatitis B, Hepatitis C Infection or Non Alcoholic Fatty Liver Disease
Chronic liver diseases of differing etiologies are among the leading causes of morbidity and mortality worldwide [1]. Chronic liver disease progresses through different pathological stages that vary from mild hepatic inflammation…
- Conditions
- HBV, NAFLD, HCV
- Trial name
- NCT02658786
- Where
- India
- Sponsor
- Institute of Liver and Biliary Sciences, India
Non-Alcoholic Fatty Liver Disease
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management.
- Trial name
- WELCOME (NCT00760513)
- Testing
- OMACOR
- Where
- United Kingdom
- Volunteers
- 103 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue
Obesity and type 2 Diabetes Mellitus prevalence has doubled in the last 30 years and nearly one fifth of UAE population has Type 2 Diabetes while more than quarter has obesity.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Type 2 Diabetes, Liver Fat
- Trial name
- NCT05751720
- Testing
- GIP/GLP-1a
- Where
- United Arab Emirates
- Volunteers
- 30 people
- Sponsor
- Dr Adnan Agha