Clinical trials: Hepatobiliary Diseases
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.
Chronic Liver Disease, Cirrhosis
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
The purpose of this study is to determine the effect on the (carbon 13 labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker (NSBB) following initial administration and after chronic use of…
- Conditions
- Chronic Liver Disease, Cirrhosis, Esophageal Varices, Portal Hypertension
- Trial name
- NCT01851252
- Testing
- Methacetin (with Breath testing device)
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Meridian Bioscience, Inc.
Healthy Participants
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants
This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy…
- Trial name
- NCT05107336
- Testing
- AZD2693
- Where
- Japan
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Liver Disease
Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference
Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases.
- Trial name
- NCT03704792
- Testing
- FibroScan 530 Compact
- Where
- 5 sites in France
- Volunteers
- 207 people
- Sponsor
- Echosens
Plaque Psoriasis, Metabolic Dysfunction-Associated Steatotic Liver Disease
A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis [PsA]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine…
- Trial name
- SEC-HOPE (NCT07683065)
- Where
- 7 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type II, Fatty Liver
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: The safety and tolerability of multiple doses of INT 747…
- Trial name
- NCT00501592
- Testing
- INT-747
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Intercept Pharmaceuticals
Nonalcoholic Steatohepatitis
A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH
The main objective of this study is to evaluate safety and efficacy of ALS-L1023 in patients with Non-alcoholic steatohepatitis
- Trial name
- NCT04342793
- Testing
- ALS-L1023 1,200mg, ALS-L1023 1,800mg
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- AngioLab, Inc.
NASH - Nonalcoholic Steatohepatitis
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
- Trial name
- NCT03611101
- Testing
- ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Meridian Bioscience, Inc.
Alagille Syndrome
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Decompensated Cirrhosis
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new…
- Trial name
- ENCORE-LF (NCT03205345)
- Testing
- Emricasan (25 mg), Emricasan (5 mg)
- Where
- 76 sites in United States
- Volunteers
- 210 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-alcoholic Fatty Liver Disease
Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan
The primary objective of this trial is to investigate the relative Bioavailability (BA) of tablet formulation of Dabigatran etexilate (DE) with and without co-administration of rabeprazole in healthy male subjects.
- Trial name
- NCT03143166
- Testing
- Dabigatran Etexilate, Rabeprazol sodium
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Steatohepatitis, Nonalcoholic, Osteo Arthritis
DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine
This is a Phase 1, open-label, 2-part, fixed-sequence, single-center, two-period, drug-drug interaction trial in healthy adult participants to determine if ECC0509 administration at steady state affects the pharmacokinetics (PK)…
- Trial name
- NCT07873229
- Testing
- ECC0509, Metformin, Caffeine
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eccogene
Hepatic Encephalopathy
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
- Trial name
- AST015 (NCT00558038)
- Testing
- AST-120, lactulose
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Ocera Therapeutics
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
NAFLD, Nonalcoholic Fatty Liver Disease
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.
- Conditions
- NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03674476
- Testing
- BMS-986036
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Non-Alcoholic Fatty Liver Disease
Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
- Trial name
- NCT04142749
- Testing
- Oltipraz
- Where
- 21 sites in South Korea
- Volunteers
- 146 people
- Sponsor
- PharmaKing
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
NASH With Fibrosis, NAFLD
AGED Diagnostics Liver Disease Assessment
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood.
- Conditions
- NASH With Fibrosis, NAFLD, Healthy
- Trial name
- AGEDDX (NCT06348563)
- Testing
- AGED Multiple Target Assay in Healthy Controls, AGED Multiple Target Assay in NAFLD Participants, AGED Multiple Target Assay in Fibrosis Participants
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
NASH - Nonalcoholic Steatohepatitis
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg.
- Trial name
- NCT05441904
- Testing
- PXL770
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Poxel SA
Obese
A Study of Distal Jejunal-release Dextrose in Obese Participants
The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose [Aphaia technology, AT]) in obese participants.
- Trial name
- NCT05385978
- Testing
- APHD-012, APHD-012P
- Where
- 9 sites in Georgia, Germany and 1 more
- Volunteers
- 150 people
- Sponsor
- Aphaia Pharma US LLC