Clinical trials: Hepatobiliary Diseases
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo.
- Trial name
- MAESTRO-NAFLD1 (NCT04197479)
- Testing
- Resmetirom
- Where
- 77 sites in United States, Puerto Rico
- Volunteers
- 1,343 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH)
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and…
- Trial name
- NCT06216041
- Testing
- IMM-H014, IMM-H014 ( FE)
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
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
Non Alcoholic Fatty Liver Disease
Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD
The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non…
- Trial name
- NCT02941549
- Testing
- Epeleuton
- Where
- 16 sites in Georgia, Ukraine and 1 more
- Volunteers
- 96 people
- Sponsor
- Afimmune
Non-Alcoholic Fatty Liver Disease
Multi-Parametric MRI Assessment of the Liver in the Dallas-FortWorth Metroplex Population
To build a Registry of volunteers by inviting them to get a LiverMultiScan(LMS)and collecting their contact information to seek interest in participating in future studies.
- Trial name
- DFWRegistry (NCT04336618)
- Testing
- Liver MultiScan
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Perspectum
Non-alcoholic Fatty Liver Disease
Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.
- Trial name
- NCT03166735
- Testing
- BI 1467335
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 114 people
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
- Trial name
- NCT04091061
- Testing
- PF-06865571 100 mg
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypercholesterolemia
Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.
- Trial name
- NCT00529178
- Testing
- Pravastatin
- Volunteers
- 232 people
- Sponsor
- Bristol-Myers Squibb
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
- Trial name
- NCT05039450
- Testing
- EFX
- Where
- 49 sites in United States, Mexico and 1 more
- Volunteers
- 213 people
- Sponsor
- Akero Therapeutics, Inc
Nonalcoholic Steatohepatitis
Norursodeoxycholic Acid vs. Placebo in NASH
This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral…
- Trial name
- NCT05083390
- Testing
- norUrsodeoxycholic acid
- Where
- Austria
- Volunteers
- 363 people
- Sponsor
- Dr. Falk Pharma GmbH
NASH - Nonalcoholic Steatohepatitis
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
- Trial name
- NCT03783897
- Testing
- EDP-305, Oral Contraceptive
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Liver Diseases, Hepatic Insufficiency
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll.
- Trial name
- NCT01870388
- Testing
- Baricitinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Nonalcoholic Fatty Liver
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
- Trial name
- NCT03763877
- Testing
- PXL770
- Where
- 15 sites in United States
- Volunteers
- 121 people
- Sponsor
- Poxel SA
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.
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
Type 2 Diabetes Mellitus, Obesity
To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants
XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management.
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Nonalcoholic Steatohepatitis
- Trial name
- XW003 (NCT04389775)
- Testing
- Cohort A, Cohort B
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or…
- Trial name
- MAESTRO-NASH (NCT03900429)
- Testing
- MGL-3196, Liver Biopsy
- Where
- 247 sites in United States, Australia and 14 more
- Volunteers
- 1,759 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.