Clinical trials: Hepatobiliary Disorders
Non-Alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
- Trial name
- NCT04481594
- Testing
- HPN-01
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hepanova Inc.
Fatty Liver
The Effect of a Probiotic on Hepatic Steatosis
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States.
- Trial name
- NCT00099723
- Testing
- VSL#3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- VSL Pharmaceuticals
Nonalcoholic Steatohepatitis
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group.
- Trial name
- NCT01466894
- Testing
- IMM 124-E
- Sponsor
- Immuron Ltd.
NASH - Nonalcoholic Steatohepatitis
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo.
- Trial name
- NCT03468556
- Testing
- SNP-610
- Volunteers
- 80 people
- Sponsor
- Sinew Pharma Inc.
NAFLD
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
- Trial name
- NCT03261739
- Testing
- RYI-018
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 84 people
- Sponsor
- Bird Rock Bio, Inc.
Fatty Liver, Nonalcoholic, NAFLD
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
- Conditions
- Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03656744
- Testing
- HTD1801
- Where
- 17 sites in United States
- Volunteers
- 101 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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.
Acute-On-Chronic Liver Failure, Alcoholic Hepatitis
A-TANGO Phase 2 Study
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment…
- Conditions
- Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
- Trial name
- A-TANGO (NCT06890039)
- Testing
- TAK-242, G-CSF (Filgrastim)
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- Yaqrit Ltd
Non-Alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.
- Trial name
- NCT04336800
- Testing
- LiverMultiscan
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Perspectum
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
Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
This study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this…
- Conditions
- Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency, Neurocognitive Deficit, Malnutrition
- Trial name
- NCT04807478
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Sponsor
- Fresenius Kabi
Hepatic Impairment
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal…
- Trial name
- NCT07428525
- Testing
- AMG 133
- Where
- 5 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Steatohepatitis, Nonalcoholic
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement…
- Trial name
- NCT04932512
- Testing
- ION224
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 160 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
Nonalcoholic Steatohepatitis
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M…
- Trial name
- FORTUNA (NCT05809934)
- Testing
- AZD2693
- Where
- 163 sites in United States, Argentina and 20 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
NAFLD, NASH
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)
- Trial name
- NCT04006145
- Testing
- Elobixibat
- Where
- 10 sites in United States
- Volunteers
- 47 people
- Sponsor
- Albireo
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
- Trial name
- NCT03976401
- Testing
- EFX
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 110 people
- Sponsor
- Akero Therapeutics, Inc
NASH/MASH, NAFLD/MASLD
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
- Trial name
- NCT06161571
- Testing
- Efruxifermin
- Where
- 211 sites in United States, Argentina and 11 more
- Volunteers
- 700 people
- Sponsor
- Akero Therapeutics, Inc
Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
2-Week Study In People With Nonalcoholic Fatty Liver Disease
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
- Trial name
- NCT03513588
- Testing
- PF-06865571
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis (NASH)
The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research
- Trial name
- NCT04194242
- Testing
- HEC96719 tablets
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.