Clinical trials: Hepatobiliary Diseases
Non-alcoholic Steatohepatitis (NASH)
A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects
This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing single doses
- Trial name
- NCT02612662
- Testing
- AZD4076
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non-Alcoholic Fatty Liver Disease
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.
- Trial name
- NCT03350165
- Testing
- K-877
- Where
- 16 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Kowa Company, Ltd.
Overweight and Obesity
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its…
- Trial name
- CONTEMPO (NCT06151964)
- Testing
- AZD9550, AZD9550 and AZD6234
- Where
- 15 sites in Austria, Canada and 3 more
- Volunteers
- 166 people
- Sponsor
- AstraZeneca
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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.
Non-alcoholic Steatohepatitis
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
- Trial name
- NCT06569524
- Where
- 53 sites in China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Heart Failure
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants
Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body.
- Trial name
- NCT04722562
- Testing
- Vericiguat (BAY1021189)
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bayer
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatitis B Virus Associated Liver Disease
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation.
- Trial name
- NCT01421212
- Testing
- Hepatitis B Immune Globulin (Boca HBVIg)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biotest Pharmaceuticals Corporation
T2DM With NAFLD
AZD4076 in Type 2 Diabetic Subjects With Non-Alcoholic Fatty Liver Disease.
This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose study conducted at a single site. The study plans to include up to approximately 46 evaluable subjects with Type 2 Diabetes Mellitus…
- Trial name
- NCT02826525
- Testing
- AZD4076
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Healthy
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06835919 in healthy adult Japanese participants.
- Trial name
- NCT04427917
- Testing
- PF-06835919
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
NASH - Nonalcoholic Steatohepatitis
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human…
- Trial name
- NCT03610945
- Testing
- Fluconazole, Quinidine, EDP-305
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Trial name
- NCT05775159
- Testing
- Volrustomig, Bevacizumab, Lenvatinib
- Where
- 46 sites in United States, China and 7 more
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia.
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
- Trial name
- NCT06255782
- Testing
- ECUR-506
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 20 people
- Sponsor
- iECURE, Inc.
Non-alcoholic Fatty Liver Disease
6-week Safety and PD Study in Adults With NAFLD
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH…
- Trial name
- NCT03256526
- Testing
- PF-06835919 Low Dose, PF-06835919 High Dose
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
Pre Diabetes, Impaired Glucose Tolerance
Effect of F. Prausnitzii on Glycemic Control
The microbiota is associated with a wide spectrum of diseases including diabetes and non-alcoholic fatty liver disease. In this study we will investigate if the bacteria F.
- Conditions
- Pre Diabetes, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease
- Trial name
- NCT04938843
- Testing
- F. prausnitzii and D. piger
- Where
- Sweden
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- MetaboGen AB
NASH - Nonalcoholic Steatohepatitis
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.
- Trial name
- NCT04054310
- Testing
- Liver Multi Scan
- Where
- 7 sites in United States
- Volunteers
- 225 people
- Sponsor
- Perspectum
Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease
Identification of Liver Fibrosis Biomarkers
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant…
- Conditions
- Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- Trial name
- NCT06819917
- Testing
- Identification of liver fibrosis biomarkers
- Where
- 2 sites in Denmark, Germany
- Volunteers
- 575 people
- Sponsor
- Roche Diagnostics GmbH
Hepatitis C
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the…
- Trial name
- Eclipse 2 (NCT01025297)
- Testing
- Interleukin-7
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 18 people
- Sponsor
- Cytheris SA
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