Clinical trials: Non-Alcoholic Steatohepatitis
Fatty Liver
Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).
- Trial name
- NCT01284634
- Testing
- GWP42003 200 mg/day Dose, GWP42003 400 mg/day Dose, GWP42003 800 mg/day Dose
- Where
- 3 sites in United Kingdom
- Volunteers
- 25 people
- Sponsor
- GW Research Ltd
Compliance Behavior
Beta Glucosylceramide for Treatment of NASH
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
- Trial name
- NCT02126306
- Testing
- Beta Glucosylceramide
- Volunteers
- 23 people
- Sponsor
- Hadassah Medical Organization
Fatigue
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue. Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3…
- Trial name
- NCT02331589
- Testing
- KRG (Korea Red ginseng)
- Volunteers
- 75 people
- Sponsor
- Chuncheon Sacred Heart Hospital
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
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 (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
Liver Diseases, Blood Disorder
NASH Fitness Intervention in Thrombosis Trial (NASHFit)
Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival.
- Conditions
- Liver Diseases, Blood Disorder, Digestive System Disease
- Trial name
- NCT03518294
- Testing
- Aerobic Exercise
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Milton S. Hershey Medical Center
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.
Non-Alcoholic Fatty Liver Disease, Hepatitis B
A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada
(1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD in Canada do not have immunity to hepatitis B.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Hepatitis B, Vaccine Reaction
- Trial name
- NCT02985450
- Testing
- Engerix-B
- Where
- Canada
- Volunteers
- 82 people
- Sponsor
- University of Calgary
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Ultrasound Method to Measure Fibrosis of the Liver in Children
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV
- Trial name
- NCT02086708
- Testing
- Shear Wave sonoelastography
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Non-Alcoholic Fatty Liver Disease, Insulin Resistance
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
- Conditions
- Non-Alcoholic Fatty Liver Disease, Insulin Resistance, High Intensity Interval Training, Childhood Obesity
- Trial name
- NCT04342390
- Testing
- High-Intensity Interval Training (HIIT)
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Arkansas Children's Hospital Research Institute
Nonalcoholic Steatohepatitis (NASH)
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NASH (NCT04134091)
- Testing
- LPCN 1144 Formulation A, LPCN 1144 Formulation B
- Where
- 19 sites in United States
- Volunteers
- 56 people
- Sponsor
- Lipocine Inc.
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
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- LFQ (NCT04657523)
- Testing
- Investigational Liver Fat Quantification Software
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Philips Clinical & Medical Affairs Global
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
Metabolic Syndrome, Nonalcoholic Fatty Liver Disease
Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT)
The purpose of the study is to demonstrate that the ¹³C-Octanoate Breath Test (OBT) can be used as an aid, in conjunction with other clinical information and medical history, for evaluating disease severity and detecting NASH…
- Trial name
- NCT01244503
- Testing
- Sodium Octanoate Breath Test
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Virginia Commonwealth University
Non-Alcoholic Fatty Liver Disease, Obesity
Alternate Day Fasting, Exercise, and NAFLD
Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes.
- Trial name
- NCT04004403
- Testing
- Alternate day fasting, Exercise
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
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
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.
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
- Trial name
- Harmony (NCT04767529)
- Testing
- Efruxifermin
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 128 people
- Sponsor
- Akero Therapeutics, Inc