Clinical trials: NASH With Fibrosis, active
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
Metabolic Associated Fatty Liver Disease, Metabolic Associated Steatotic Liver Disease
Evaluation of Non-Invasive Tests for Metabolic Liver Disease
The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers…
- Conditions
- Metabolic Associated Fatty Liver Disease, Metabolic Associated Steatotic Liver Disease, Cirrhosis, Liver, NASH
- Trial name
- NIMBLE (NCT07122700)
- Where
- 4 sites in United States
- Volunteers
- 400 people
- Sponsor
- Foundation for the National Institutes of Health
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Exercise for an Aging Liver (EXALIVER)
The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis…
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Liver Fibrosis/NASH
- Trial name
- EXALIVER (NCT07467512)
- Testing
- Exercise, Usual Care
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
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
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
NASH With Fibrosis, MASH With Fibrosis
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).
- Trial name
- NCT06215716
- Testing
- Efruxifermin
- Where
- 359 sites in United States, Argentina and 16 more
- Volunteers
- 1,650 people
- Sponsor
- Akero Therapeutics, Inc
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Blood Collection Biorepository for Liver Disease Research
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the…
- Conditions
- Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B, Fibrosis
- Trial name
- NCT03025074
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- State University of New York at Buffalo
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity.
- Trial name
- QUS in NASH (NCT03572465)
- Testing
- Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
- Where
- Canada
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Detecting Liver Fibrosis in Patients At-risk
The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register.
- Conditions
- Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease, Nash, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- Trial name
- STELIR (NCT07775638)
- Testing
- Routine study procedure
- Where
- Norway
- Volunteers
- 1,200 people
- Sponsor
- Helse Stavanger HF
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis.
- Conditions
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH, Non-Alcoholic Steato-Hepatitis (NASH)
- Trial name
- AGL13 (NCT06843148)
- Testing
- Niacin (250mg)
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- Université de Sherbrooke
Obesity, Liver Diseases
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting…
- Conditions
- Obesity, Liver Diseases, Liver Fibrosis, Liver Fat
- Trial name
- NCT06138821
- Testing
- ESG + lifestyle modification, Lifestyle modification
- Where
- 2 sites in United States
- Volunteers
- 132 people
- Sponsor
- Pichamol Jirapinyo, MD, MPH
NASH, NAFLD
Digoxin In NASH (CODIN)
Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans.
- Conditions
- NASH, NAFLD, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Mash
- Trial name
- CODIN (NCT06588699)
- Testing
- Digoxin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Yale University
Surgery, Obesity
A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients
The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with…
- Conditions
- Surgery, Obesity, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NASHSURG (NCT03472157)
- Testing
- Lifestyle therapy, Bariatric surgery
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Lille
NASH With Fibrosis, Diabete Type 2
Non-invasive Tests for Non-alcoholic Steato-hepatitis
The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites.
- Conditions
- NASH With Fibrosis, Diabete Type 2, Obesity
- Trial name
- TEIRESEAS (NCT07502755)
- Testing
- Administration of Deuterated water
- Where
- Italy
- Volunteers
- 828 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Metabolic Syndrome X, Fatty Liver
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by…
- Conditions
- Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD
- Trial name
- ACOUSTIQ (NCT06661655)
- Testing
- Liver ultrasound
- Where
- 3 sites in France
- Volunteers
- 120 people
- Sponsor
- E-Scopics
NAFLD, NASH
LITMUS Imaging Study
The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD).
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver
- Trial name
- NCT05479721
- Where
- 18 sites in United States, Finland and 8 more
- Volunteers
- 450 people
- Sponsor
- University of Oxford
Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.
This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE)…
- Conditions
- Liver Fibrosis Due to NASH, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Alcohol Liver Disease
- Trial name
- LFMRECT (NCT06797596)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Fibronostics USA, Inc
NASH, Liver Fibrosis
Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study.
- Trial name
- NCT06364462
- Testing
- lifestyle intervention
- Volunteers
- 220 people
- Sponsor
- Beijing Friendship Hospital
Bariatric Surgery Candidate, NAFLD
Effectiveness of Bariatric Surgery for NAFLD/NASH
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery. This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH with fribrosis, to explore the…
- Conditions
- Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis
- Trial name
- NCT04366999
- Testing
- SG, RYGB, OAGB
- Where
- China
- Volunteers
- 320 people
- Sponsor
- Beijing Friendship Hospital
NAFLD, Diabetes
DIAbetes and NAFLD
Non-alcoholic hepatic steatosis (NAFLD) is characterised by the excessive accumulation of triglycerides in the liver and is often associated, in the absence of significant alcohol consumption, with insulin resistance and…
- Conditions
- NAFLD, Diabetes, NASH, Fibrosis, Liver
- Trial name
- DIANA (NCT06315361)
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS