Clinical trials: NASH
NAFLD, NASH
An Imaging-based Quantitative Biomarker Assay for NAFLD in Children
This study will validate recently developed Magnetic Resonance Imaging (MRI) and Ultrasound (US) based methods for liver fat quantification in children with obesity and healthy range of body mass index (BMI).
- Trial name
- NCT06354491
- Testing
- Magnetic Resonance Imaging (MRI), Ultrasound (US)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Non-alcoholic Steatohepatitis (NASH), Endoscopic Sleeve Gastroplasty
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with…
- Conditions
- Non-alcoholic Steatohepatitis (NASH), Endoscopic Sleeve Gastroplasty, Non-alcoholic Fatty Liver Disease (NAFLD), Endoscopic Ultrasound
- Trial name
- NCT04820036
- Testing
- Insulin Resistance, Quality of Life Assessment, Liver Function Test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Brigham and Women's Hospital
NASH, HCC
Evaluation of Risk of hEpatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the fifth most common solid cancer and the second cause of cancer-related mortality worldwide.
- Conditions
- NASH, HCC, Genetic Predisposition
- Trial name
- PERSPECTIVE (NCT06523179)
- Testing
- quantify the impact of genetic risk factors
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Diabetes Mellitus, Type 2, NAFLD
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity.
- Conditions
- Diabetes Mellitus, Type 2, NAFLD, NASH
- Trial name
- L-FibroT2DM (NCT04232293)
- Testing
- Blood tests
- Where
- 2 sites in France
- Volunteers
- 722 people
- Sponsor
- Nantes University Hospital
Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
- Trial name
- NCT04004325
- Testing
- FT-4101, Deuterated Water
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Forma Therapeutics, Inc.
Nonalcoholic Steatohepatitis (NASH)
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
- Trial name
- NCT05842512
- Testing
- ADI-PEG20
- Where
- 10 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Polaris Group
Non-alcoholic Fatty Liver Disease NAFLD, Non-alcoholic Steatohepatitis NASH
Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease
The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis.
- Trial name
- NCT07180745
- Testing
- Pioglitazone (PIO), Empagliflozin, Statin (Atorvastatin)
- Where
- Egypt
- Volunteers
- 400 people
- Sponsor
- Badr University
NAFLD, NASH - Nonalcoholic Steatohepatitis
The Franciscus Obesity NASH Study
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Trial name
- FONS (NCT05499949)
- Testing
- NASH screening, Cardiac dysfunction screening, Liver biopsy
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Franciscus Gasthuis
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH)
How Abnormal Function of Fat Tissue in Type 1 Diabetes Contributes to Fat in the Liver
Steatotic liver disease associated with metabolic dysfunction (MASLD) is a disease caused by excess fat storage in the liver. Excessive fat delivery to the liver and MASLD typically occurs in people with abdominal obesity and…
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Steato-Hepatitis (NASH), Type 1 Diabetes Mellitus
- Trial name
- AGL14 (NCT07133854)
- Testing
- Imaging PET/MRI, Stable isotope infusions, meal test
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Université de Sherbrooke
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.
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
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor
This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patatin-like phospholipase domain…
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Genetic Risk Factor
- Trial name
- NCT06024408
- Testing
- ALN-PNP
- Where
- 5 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
NASH, NASH - Nonalcoholic Steatohepatitis
Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH.
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Liver Diseases
- Trial name
- ENLIGHTEN (NCT06352177)
- Testing
- Noom Weight Application
- Sponsor
- Milton S. Hershey Medical Center
Nonalcoholic Steatohepatitis (NASH)
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
- Trial name
- NCT02443116
- Testing
- NGM282
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 254 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease
This is a two-part study. In Part A, eligible participants will undergo a baseline diagnostic liver biopsy to determine non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) and fibrosis stage, but will not receive study…
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease
- Trial name
- NCT05560607
- Testing
- AZD7503 Intervention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- AstraZeneca
NASH - Nonalcoholic Steatohepatitis
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
- Trial name
- NCT03912532
- Testing
- NGM282
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 171 people
- Sponsor
- NGM Biopharmaceuticals, Inc
NASH - Nonalcoholic Steatohepatitis
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects.
- Trial name
- NCT04972396
- Testing
- Pemvidutide, Metformin, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
- Trial name
- Harmony (NCT04767529)
- Testing
- Efruxifermin
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 128 people
- Sponsor
- Akero Therapeutics, Inc
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.