Clinical trials: Hepatobiliary Disease
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
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.
Non-Alcoholic Fatty Liver Disease
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
- Trial name
- NCT05292911
- Testing
- ALT-801
- Where
- 13 sites in United States
- Volunteers
- 64 people
- Sponsor
- Altimmune, Inc.
Nonalcoholic Steatohepatitis
CM-101 in NASH Patients - The SPLASH Study
This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with…
- Trial name
- NCT05824156
- Testing
- 5 mg/kg CM-101
- Where
- 9 sites in Israel
- Volunteers
- 23 people
- Sponsor
- ChemomAb Ltd.
Nonalcoholic Steatohepatitis
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
- Trial name
- NCT02510599
- Testing
- solithromycin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Melinta Therapeutics, Inc.
Nonalcoholic Steatohepatitis
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods.
- Trial name
- NCT05983328
- Testing
- HUYPS-1 one tablet, HUYPS-1 nine tablets
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
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 Steatohepatitis (NASH)
Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the safety, the tolerability and the short term effect on liver enzymes of TRO19622 500 mg for one month in patients with Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NCT00666016
- Testing
- TRO19622
- Where
- 5 sites in France
- Volunteers
- 22 people
- Sponsor
- Hoffmann-La Roche
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Disease
Management Concepts of Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD) Among Chinese Physicians
This study is a cross-sectional survey-based study. The main goal of this study is to investigate the attitudes, perceptions, and clinical practice in assessing liver fibrosis following a metabolic dysfunction-associated…
- Trial name
- NCT07682363
- Testing
- No treatment is given
- Where
- China
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Alcoholic Liver Disease
Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients.
- Trial name
- NCT03503708
- Testing
- Livitol-70
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Composite Interceptive Med Science
Non-alcoholic Fatty Liver Disease
A Clinical Trial of XZP-6019 Tablets in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase.
- Trial name
- NCT05063968
- Testing
- XZP-6019 tablet
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Liver Cirrhosis
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein…
- Trial name
- NCT04987034
- Testing
- EchoTip® Insight™
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Cook Research Incorporated
Nonalcoholic Steatohepatitis (NASH)
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
- Trial name
- NCT05842512
- Testing
- ADI-PEG20
- Where
- 10 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Polaris Group
Hepatic Impairment, Healthy, Hepatic Insufficiency
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease
The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.
- Conditions
- Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults
- Trial name
- NCT07677358
- Testing
- Atirmociclib
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Fontan, Right Heart Failure
Cholate Clearance in Fontan and Heart Failure
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease…
- Trial name
- NCT07009132
- Testing
- Dual cholate clearance assay, MRI
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides.
- Trial name
- NCT04399538
- Testing
- PF-06865571, PF-05221304
- Where
- 20 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Pfizer
NAFLD (Non-alcoholic Fatty Liver Disease)
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Primary Objective: To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease. Secondary objectives: To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver…
- Trial name
- NASH/MASH (NCT07308548)
- Testing
- HP515 10 mg Tablet, HP515 20 mg Tablet
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Healthy Adult Participants, Liver Disease Chronic
Validation of Different Methods for HepQuant DuO® Blood Sample Collection
This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test.
- Trial name
- NCT07473817
- Testing
- HepQuant DuO Test
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC