Clinical trials: Fatty Liver Disease, Nonalcoholic
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
A Study to See if Low Level Laser Light Therapy (LLLT) Can Improve the Condition of Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase (ALT) levels in individuals with nonalcoholic…
- Trial name
- NCT03163810
- Testing
- Erchonia Verju Laser, Erchonia EVRL Laser
- Where
- United States
- Sponsor
- Erchonia Corporation
NASH - Nonalcoholic Steatohepatitis
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks.
- Trial name
- NCT04697810
- Testing
- Namodenoson
- Where
- 24 sites in Bosnia and Herzegovina, Bulgaria and 4 more
- Volunteers
- 114 people
- Sponsor
- Can-Fite BioPharma
Nonalcoholic Fatty Liver Disease
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
- Trial name
- SARONAPLUS (NCT05211284)
- Testing
- Saroglitazar Magnesium 4 mg
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Zydus Therapeutics Inc.
Non-alcoholic Steatohepatitis, Chronic Liver Disease
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive…
- Conditions
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis
- Trial name
- ELEVATE (NCT00678587)
- Testing
- Eltrombopag
- Where
- 107 sites in United States, Argentina and 11 more
- Volunteers
- 292 people
- Sponsor
- GlaxoSmithKline
Non-Alcoholic Fatty Liver
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an…
- Trial name
- NCT03953456
- Testing
- elafibranor 120mg
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Genfit
NASH - Nonalcoholic Steatohepatitis, Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X…
- Trial name
- NCT03976687
- Testing
- EYP001a
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Steatohepatitis
A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
The main aim of this study is to evaluate the safety and tolerability of ontamalimab in participants with a liver disease called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) with…
- Trial name
- NCT07052682
- Testing
- Ontamalimab
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Takeda
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Healthy Volunteers
Multiple Ascending Dose and DDI Study
Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design.
- Trial name
- NCT03031119
- Testing
- PF-06835919, atorvastatin
- Where
- Belgium
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a…
- Trial name
- NEXSCOT (NCT04147195)
- Testing
- LYS006, Tropifexor
- Where
- 10 sites in United States, Argentina and 1 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
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.
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
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
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
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.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
- Trial name
- NCT04710524
- Testing
- FM101 150 mg BID, FM101 300 mg BID
- Where
- 12 sites in Hungary, Poland and 1 more
- Volunteers
- 60 people
- Sponsor
- Future Medicine
Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Metabolic Syndrome
- Trial name
- Aramchol003 (NCT01094158)
- Testing
- Aramchol
- Where
- 11 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Galmed Medical Reserch
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.
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.