Clinical trials: Hepatic Steatosis
Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH)
The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF
The main purpose of this study is to compare the effectiveness of various non-invasive elastography techniques at determining liver stiffness measures in human subjects.
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Liver Fibroses, Liver Steatoses
- Trial name
- NCT04682600
- Testing
- Liver Incytes System
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Sonic Incytes
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
NAFLD
The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease
The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.
- Trial name
- NCT02546609
- Testing
- Leu-Met-Sil 0.5, Leu-Met-Sil 1.0
- Where
- 13 sites in United States
- Volunteers
- 91 people
- Sponsor
- NuSirt Biopharma
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD
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
- DPAILO-1 (NCT06344364)
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- 3 sites in Hong Kong, Spain
- Volunteers
- 1,241 people
- Sponsor
- PharmaNest, Inc
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.
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Healthy Volunteers, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug…
- Trial name
- NCT05648214
- Testing
- ALN-PNP
- Where
- 6 sites in United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease.
- Conditions
- Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
- Trial name
- TESA-LIVER (NCT07481734)
- Testing
- Tesamorelin, Standardized lifestyle counseling
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hudson Biotech
Non Alcoholic Fatty Liver
Efficacy and Safety of a Probiotic Composition as Adjunct in MAFL Management
Some studies have shown beneficial results with probiotics on hepatic function of subjects with fatty liver, but significant variability has been noted among probiotic formulations.
- Trial name
- NCT04823676
- Testing
- Probiotic composition
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- AB Biotics, SA
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Fatty Liver, Hepatic Steatosis
Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis
This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56…
- Conditions
- Fatty Liver, Hepatic Steatosis, Liver Steatosis
- Trial name
- NCT02456766
- Testing
- FibroTouch, Liver Biopsy
- Where
- 8 sites in China
- Volunteers
- 240 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
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.
NASH - Nonalcoholic Steatohepatitis
An Open-Label Study to Assess the Hepatic Protection Effect of SNP-612, in Patients With NAFLD
The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612.
- Trial name
- NCT03868566
- Testing
- SNP-612 dose1, SNP-612 dose2
- Where
- Taiwan
- Volunteers
- 90 people
- Sponsor
- Sinew Pharma Inc.
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
This is a study of experimental medication BMS-986036 given to healthy participants.
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03445208
- Testing
- BMS-986036
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
MASH, MASLD
Global Research Initiative for Patients Screening on MASH
GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe…
- Conditions
- MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver
- Trial name
- GRIPonMASH (NCT05651724)
- Where
- 13 sites in Belgium, Czechia and 8 more
- Volunteers
- 10,000 people
- Sponsor
- Julius Clinical
Liver Diseases, Hypertension, Portal
A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the…
- Trial name
- NCT05282121
- Testing
- Avenciguat, Empagliflozin
- Where
- 31 sites in United States, Argentina and 14 more
- Volunteers
- 90 people
- Sponsor
- Boehringer Ingelheim