Clinical trials: Non-Alcoholic Steatohepatitis(NASH)
NASH - Nonalcoholic Steatohepatitis
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg.
- Trial name
- NCT05441904
- Testing
- PXL770
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Poxel SA
NAFLD - Nonalcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis
Effects of Exercise on VLDL-TG Metabolism
Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH) and cirrhosis.
- Trial name
- NCT03678727
- Where
- Denmark
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
NAFLD, NASH - Nonalcoholic Steatohepatitis
Splanchnic and Systemic VLDL-TG and FFA Balance
To determine differences between NAFLD and NASH subjects with respect to hepatic FA metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and peripheral kinetics (oxidation and tissue storage).
- Trial name
- NCT04292977
- Where
- Denmark
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
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
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver
This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin…
- Conditions
- Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis, NAFLD
- Trial name
- NCT04976283
- Testing
- Pioglitazone, Empagliflozin, Pioglitazone + Empagliflozin
- Where
- Pakistan
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Getz Pharma
Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic…
- Trial name
- NCT02781584
- Testing
- SEL, FIR, CILO
- Where
- 13 sites in United States, New Zealand
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
NASH - Nonalcoholic Steatohepatitis
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.
- Trial name
- NCT05022693
- Testing
- BIO89-100
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- 89bio, Inc.
NASH - Nonalcoholic Steatohepatitis, NAFLD
Characterization of the Platelet Inflammatory Response in NAFL and NASH
The primary objective of the study is to identify which features of platelet activation promote the inflammatory response that underlies the progression from NAFL to NASH. Therefore, the investigators plan: 1.
- Trial name
- NCT05128253
- Testing
- High fat meal in a subset of patients with NAFL or NASH
- Where
- 2 sites in Italy
- Volunteers
- 44 people
- Sponsor
- Stefania Basili
Non-alcoholic Steatohepatitis (NASH)
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States.
- Trial name
- NCT05050721
- Testing
- CT imaging
- Where
- United States
- Sponsor
- Methodist Health System
Non-Alcoholic Steatohepatitis (NASH)
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04140123
- Testing
- ZSP1601
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
NASH - Nonalcoholic Steatohepatitis
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of SNP-630 in Health Subjects.
To evaluate the safety, tolerability and Pharmacokinetic profile of SNP-630 when oral administered to healthy subjects.
- Trial name
- NCT04808154
- Testing
- SNP-630
- Where
- Taiwan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Obese Patients With Non-alcoholic Steatohepatitis (NASH)
Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
The purpose of this study was to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)
- Trial name
- NCT03205150
- Testing
- LIK066
- Where
- 15 sites in United States, Argentina and 6 more
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
NAFLD - Nonalcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis
Curcumin for Pediatric Nonalcoholic Fatty Liver Disease
This is a single-center, randomized, double-blinded, placebo-controlled, parallel treatment groups phase 2a study of curcumin for pediatric nonalcoholic fatty liver disease (NAFLD).
- Trial name
- NCT04109742
- Testing
- phosphatidylcholine-curcumin complex supplement
- Sponsor
- Columbia University
NASH - Nonalcoholic Steatohepatitis
Effects of Plant Sterols and Stanols on Liver Inflammation
This study is a randomized, placebo-controlled, double blinded pilot study to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT…
- Trial name
- NCT05037890
- Testing
- Margarine
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Non-alcoholic Steatohepatitis (NASH)
Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
- Trial name
- FLIGHT-FXR (NCT02855164)
- Testing
- Tropifexor (LJN452)
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
NASH (Nonalcoholic Steatohepatitis), NAFLD (Nonalcoholic Fatty Liver Disease)
Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism
The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat.
- Trial name
- NCT04395950
- Testing
- PF-05221304
- Sponsor
- Columbia University
NASH - Nonalcoholic Steatohepatitis
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo.
- Trial name
- NCT04709913
- Testing
- HU6
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rivus Pharmaceuticals, Inc.
NASH - Nonalcoholic Steatohepatitis
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination…
- Trial name
- NCT03294941
- Testing
- HepQuant SHUNT Liver Diagnostic Kit
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- HepQuant, LLC
Nonalcoholic Steatohepatitis (NASH)
Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients
We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 included 34 patients received Vit.
- Trial name
- NCT04977661
- Testing
- Vitamin E, Ursodeoxycholic acid, Pentoxifylline
- Where
- Egypt
- Volunteers
- 102 people
- Sponsor
- Kafrelsheikh University