Clinical trials: Hepatobiliary Disorders
NAFLD (Non-alcoholic Fatty Liver Disease), NASH (Nonalcoholic Steatohepatitis)
a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）
This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with…
- Trial name
- NCT07128797
- Testing
- B1344
- Where
- 5 sites in China
- Volunteers
- 32 people
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd.
Nonalcoholic Steatohepatitis
Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
- Trial name
- PHYLLANTEX (NCT05343780)
- Testing
- Heptex, Rice bran
- Where
- 2 sites in Egypt
- Volunteers
- 142 people
- Sponsor
- Natural Wellness Egypt
Nonalcoholic Steatohepatitis (NASH)
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NASH (NCT04134091)
- Testing
- LPCN 1144 Formulation A, LPCN 1144 Formulation B
- Where
- 19 sites in United States
- Volunteers
- 56 people
- Sponsor
- Lipocine Inc.
NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
- Trial name
- AMBITION (NCT04480710)
- Testing
- CRV431 75mg, CRV431 225mg
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 47 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Healthy, Fatty Liver
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
A generic screening study to establish structural and/or functional baselines of specific organs.
- Conditions
- Healthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Trial name
- MASLD (NCT04873258)
- Testing
- Bioimpedence Vector Analysis
- Where
- United Kingdom
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Richmond Research Institute
Non-alcoholic Steatohepatitis
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants.
- Trial name
- NCT05848440
- Testing
- AZD9550
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Liver Disease
Clinical Study of Lyophilized Plasma in Patients With Liver Disease
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.
- Trial name
- NCT01547078
- Testing
- Lyophilized Plasma, Licensed Plasma
- Sponsor
- HemCon Medical Technologies, Inc
Cardiac Disorder, Hepatic Disorder
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers.
- Conditions
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder, Kidney Disorder
- Trial name
- NCT06468787
- Testing
- Kosmos Anatomical Object Labeling and View Identification Algorithms
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Overweight, Fatty Liver Disease
The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults
To assess whether orange peel fermentation has the effect of reducing body fat in adults
- Trial name
- NCT04496895
- Testing
- orange peel fermentation
- Where
- Taiwan
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- TCI Co., Ltd.
Non-alcoholic Fatty Liver Disease
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment.
- Trial name
- NCT03681457
- Testing
- LJN452
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Non-alcoholic Fatty Liver Disease in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
Non-alcoholic Steatohepatitis
Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy Males
1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men. 2.
- Trial name
- NCT06308861
- Testing
- Single administration Amg dose Group, Single administration Bmg dose Group, Single administration Cmg dose Group
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- J2H Biotech
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- LFQ (NCT04657523)
- Testing
- Investigational Liver Fat Quantification Software
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Non Alcoholic Steatohepatitis (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
NASH - Nonalcoholic Steatohepatitis
Ascending Dose Study of HU6 in Healthy Volunteers
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next…
- Trial name
- NCT04463017
- Testing
- HU6
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Rivus Pharmaceuticals, Inc.
Kidney Failure, Liver Failure, Chronic
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol…
- Conditions
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- Trial name
- NCT03627013
- Testing
- Custodiol-N Solution, Custodiol HTK Solution
- Where
- 4 sites in Austria
- Volunteers
- 362 people
- Sponsor
- Dr. F. Köhler Chemie GmbH