Clinical trials: Liver Fibrosis/NASH
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
Nonalcoholic Steatohepatitis
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are: To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or…
- Trial name
- ATLAS (NCT03449446)
- Testing
- SEL, FIR, CILO
- Where
- 101 sites in United States, Australia and 4 more
- Volunteers
- 395 people
- Sponsor
- Gilead Sciences
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-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Liver Diseases, Liver Cirrhosis
Palliative Care for Non-Malignant Diseases (COMPASS Trial)
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes…
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH (Non-Alcoholic Steatohepatitis)
- Trial name
- COMPASS (NCT03022630)
- Testing
- Comprehensive Palliative Care services, Usual hepatic care
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Vanderbilt University Medical Center
Hepatitis
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol.
- Trial name
- NCT00062764
- Testing
- Actos (Pioglitazone)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Fatty Liver, Nonalcoholic, Diabetes Mellitus, Type 2
Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries.
- Trial name
- NCT04241575
- Testing
- Simple fibrosis scores and electronic reminder messages
- Where
- Hong Kong
- Volunteers
- 1,061 people
- Sponsor
- Chinese University of Hong Kong
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
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 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
Non Alcoholic Steatohepatitis (NASH)
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic…
- Trial name
- REGENERATE (NCT02548351)
- Testing
- Obeticholic Acid
- Where
- 346 sites in United States, Australia and 19 more
- Volunteers
- 2,477 people
- Sponsor
- Intercept Pharmaceuticals
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
Hypertension, Portal
Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also…
- Trial name
- NASH-CX (NCT02462967)
- Testing
- GR-MD-02
- Where
- 46 sites in United States
- Volunteers
- 162 people
- Sponsor
- Galectin Therapeutics Inc.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
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 Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
Non-Alcoholic Fatty Liver Disease
The Effect of GLP-1 Analogues on Liver Steatosis and Fibrosis in Diabetic and Obese Patients in a Clinical Setting
This study aims to measure the effect of GLP-1 analogues on non-alcoholic fatty liver disease in patients with diabetes and/or obesity in a clinical context.
- Trial name
- GLP1_NAFLD (NCT07021443)
- Testing
- non-interventional
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitair Ziekenhuis Brussel
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)
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02854605
- Testing
- GS-9674
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 140 people
- Sponsor
- Gilead Sciences