Clinical trials: Steatohepatitis
Nonalcoholic Steatohepatitis
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
- Trial name
- AURORA (NCT03028740)
- Testing
- Cenicriviroc
- Where
- 346 sites in United States, Australia and 26 more
- Volunteers
- 1,778 people
- Sponsor
- Tobira Therapeutics, Inc.
Liver Fibrosis, Fatty Liver
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis…
- Trial name
- NCT06051669
- Testing
- iLivTouch, FibroScan
- Where
- 4 sites in United States
- Volunteers
- 418 people
- Sponsor
- New Discovery LLC
Non-Alcoholic Fatty Liver
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an…
- Trial name
- NCT03953456
- Testing
- elafibranor 120mg
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Genfit
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.
Non-Alcoholic Steatohepatitis (NASH)
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
- Trial name
- IMPACT (NCT05989711)
- Testing
- Pemvidutide
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 212 people
- Sponsor
- Altimmune, Inc.
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.
Non Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis…
- Trial name
- NCT04880187
- Testing
- AXA1125
- Where
- 75 sites in United States, Australia and 5 more
- Volunteers
- 273 people
- Sponsor
- Axcella Health, Inc
Non Alcholic Fatty Liver Disease
Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in…
- Trial name
- NCT07452744
- Testing
- Picroliv
- Where
- 6 sites in India
- Volunteers
- 170 people
- Sponsor
- Bioagile Therapeutics Pvt. Ltd.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH
This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis.
- Trial name
- NCT07016633
- Testing
- IMM-H014
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
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
Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH.
- Conditions
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- Trial name
- MASH (NCT06939816)
- Testing
- Vonafexor low dose, Vonafexor high dose
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Enyo Pharma
Non-alcoholic Fatty Liver Disease (NAFLD)
Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease
This short-term, randomized, placebo-controlled, investigator-initiated trial aims to establish metabolic improvements in NAFLD subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate…
- Trial name
- NAFLD (NCT04330326)
- Testing
- Metabolic Cofactor Supplementation, Sorbitol
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people
- Sponsor
- ScandiBio Therapeutics AB
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
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.
Steatohepatitis
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT01154985
- Testing
- EPA-E 300 mg capsule
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 243 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
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.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
- Trial name
- NCT04710524
- Testing
- FM101 150 mg BID, FM101 300 mg BID
- Where
- 12 sites in Hungary, Poland and 1 more
- Volunteers
- 60 people
- Sponsor
- Future Medicine
Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.
- Conditions
- Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver
- Trial name
- NCT05357248
- Testing
- BT-NCBT-00X
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Better Therapeutics
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
NASH, Fatty Liver
Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.
- Conditions
- NASH, Fatty Liver, NAFLD, Weight Loss
- Trial name
- NCT05015491
- Testing
- Noom Healthy Weight Program
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Noom Inc.