Clinical trials: Hepatobiliary Disorders
Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
Primary Objective: To evaluate the dose response relationship of SAR425899 compared to placebo on resolution of non-alcoholic steatohepatitis (NASH) with no worsening of fibrosis in diabetic and non-diabetic patients with…
- Trial name
- Restore (NCT03437720)
- Testing
- SAR425899
- Sponsor
- Sanofi
Hepatitis C, Liver Disease
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination…
- Trial name
- NCT02094443
- Testing
- Alisporivir, Ribavirin
- Where
- 16 sites in United States, France
- Volunteers
- 52 people
- Sponsor
- Debiopharm International SA
Chronic Liver Disease, Hepatocellular Carcinoma (HCC)
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT measurement to…
- Trial name
- OBT for HCC (NCT01433016)
- Testing
- 13C Sodium Octanoate
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Meridian Bioscience, Inc.
Rheumatoid Arthritis, Non-Alcoholic Steatohepatitis
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.
- Trial name
- NCT05053165
- Testing
- LB-P6, LB-P8
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LISCure Biosciences
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
Fatty Liver Disease
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat.
- Trial name
- NCT07214870
- Testing
- NNC4005-001
- Where
- Canada
- Volunteers
- 29 people
- Sponsor
- Novo Nordisk A/S
Liver Diseases, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Multiparametric MRI
This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS…
- Conditions
- Liver Diseases, Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- Trial name
- NCT03743272
- Testing
- LiverMultiScan
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Perspectum
Non Alcholic Fatty Liver Disease
Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in…
- Trial name
- NCT07452744
- Testing
- Picroliv
- Where
- 6 sites in India
- Volunteers
- 170 people
- Sponsor
- Bioagile Therapeutics Pvt. Ltd.
Liver Inflammation, Fatty Liver Disease
LivQ-box® Parameters in the Diagnosis of Liver Inflammation
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
- Trial name
- NCT06802731
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- NCT06493253
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- United States
- Volunteers
- 1,519 people
- Sponsor
- PharmaNest, Inc
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE)…
- Trial name
- NCT06600321
- Testing
- ALN-BCAT, Pembrolizumab
- Where
- 23 sites in United States, Italy and 1 more
- Volunteers
- 158 people
- Sponsor
- Alnylam Pharmaceuticals
Nonalcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver Disease
Phase 2b Study of GSK4532990 in Adults With NASH
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4).
- Trial name
- HORIZON (NCT05583344)
- Testing
- GSK4532990
- Where
- 170 sites in United States, Argentina and 15 more
- Volunteers
- 284 people
- Sponsor
- GlaxoSmithKline
NASH - Nonalcoholic Steatohepatitis
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
- Trial name
- NCT03748628
- Testing
- EDP-305
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
Pruritus
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus
This study is a multi-center, randomized, double-blind, placebo-controlled study. About 90 liver disease subjects with moderate or above pruritus are planned to be enrolled.
- Trial name
- NCT04999787
- Testing
- HSK21542
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
- Trial name
- NCT04618744
- Testing
- ORMD-0801 (Insulin) capsule 8 mg BD
- Where
- 3 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Oramed, Ltd.
MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study of Resmetirom in Children and Adolescents With MASH
This study will evaluate the safety, pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the drug), and pharmacodynamics (how the drug affects the body) of resmetirom in children and adolescents with…
- Trial name
- NCT07763015
- Testing
- Resmetirom
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
- Trial name
- NCT05118360
- Testing
- ASC41 2 mg, ASC41 4 mg
- Sponsor
- Gannex Pharma Co., Ltd.
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
Metabolic Dysfunction-Associated Fatty Liver Disease
Evaluate the Effect of Synbiotics on MAFLD
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at…
- Trial name
- MAFLD-RCT (NCT06537882)
- Testing
- G-NiiB synbiotics formula (SLP07)
- Where
- Hong Kong
- Volunteers
- 54 people
- Sponsor
- GenieBiome Limited