Clinical trials: NASH (Non-Alcoholic Steatohepatitis)
NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.
- Trial name
- BARI (NCT03294850)
- Testing
- Bariatric surgery, HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AdventHealth Translational Research Institute
Steatosis of Liver, NASH - Nonalcoholic Steatohepatitis
The Liver in the World Trade Center Health Program General Responder Cohort and Controls
This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.
- Trial name
- NCT03858920
- Testing
- Fibroscan of Liver, Low-dose non-contrast CT
- Where
- United States
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
- Conditions
- Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis, Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- Trial name
- NCT03970031
- Testing
- MSDC-0602K
- Volunteers
- 1,800 people
- Sponsor
- Cirius Therapeutics, Inc.
NAFLD, NASH
THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)
The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis
- Trial name
- FRAMES (NCT04925362)
- Testing
- Biological specimens, Additional visit
- Volunteers
- 900 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Liver Disease, NASH - Nonalcoholic Steatohepatitis
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
A Phase 1a, Double Blind, Placebo-Controlled, Single-Center, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Volunteers
- Trial name
- NCT04146805
- Testing
- BLD-0409
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Blade Therapeutics
Nonalcoholic Steatohepatitis (NASH)
A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - multiple ascending dose (MAD) phase, and Part C - Food Effect (FE) phase.
- Trial name
- NCT04913090
- Testing
- XZP-5610 Tablet (for Part A), XZP-5610 Tablet (for Part B), XZP-5610 Tablet （for "Part C1"）
- Where
- China
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
NASH, NASH - Nonalcoholic Steatohepatitis
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled.
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Type 2 Diabetes, Diabetes Type 2
- Trial name
- NCT04702490
- Testing
- MET409 Active, Empagliflozin
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Metacrine, Inc.
NASH - Nonalcoholic Steatohepatitis, Liver Fibroses
Liquid Biopsy for NASH and Liver Fibrosis
Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular…
- Trial name
- LIBRA (NCT04677101)
- Testing
- Liver Biopsy
- Where
- 2 sites in Italy
- Volunteers
- 150 people
- Sponsor
- Catholic University of the Sacred Heart
NASH - Nonalcoholic Steatohepatitis, NAFLD
NASH in Subjects With Different Classes of Obesity
It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, Obesity, Obesity, Morbid
- Trial name
- CONNECT (NCT04653103)
- Testing
- Liver biopsy
- Where
- 2 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Catholic University of the Sacred Heart
Nonalcoholic Steatohepatitis (NASH)
Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects
The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects
- Trial name
- NCT04546984
- Testing
- HEC96719
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
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.
Obesity, NASH - Nonalcoholic Steatohepatitis
Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH
The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.
- Conditions
- Obesity, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Trial name
- NCT03538236
- Testing
- Intragastric balloon, Lifestyle intervention
- Sponsor
- Johns Hopkins University
Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Plant Stanols and Liver Inflammation in Overweight and Obese Children
Obesity is associated with a variety of co-morbidities. Children with obesity are more likely to have risk factors associated with cardiovascular diseases (CVD) and CVD risk markers (e.g.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, NAFLD, NASH
- Trial name
- NCT04783116
- Testing
- Plant stanols (3g/day)
- Where
- Netherlands
- Volunteers
- 52 people
- Sponsor
- Maastricht University Medical Center
NASH - Nonalcoholic Steatohepatitis
Effect of DMR in the Treatment of NASH
Non-alcoholic fatty liver disease (NAFLD) is a frequent disease affecting up to 25% of the USA population, 2-44% in Europe and up to 42,6-69,5% in patients with type 2 diabetes.
- Trial name
- DMR_NASH_001 (NCT03536650)
- Testing
- DMR
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- Erasme University Hospital
Non-Alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects
- Trial name
- NCT04481594
- Testing
- HPN-01
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hepanova Inc.
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
NAFLD, NASH - Nonalcoholic Steatohepatitis
Safety and Tolerability of Novel Medical Nutrition Products for NAFLD Treatment
To the moment, only limited data are present on the efficacy of changes in diet composition of patients with non-alcoholic fatty liver disease (NAFLD).
- Trial name
- 052920190055 (NCT04308980)
- Testing
- Specialized product for medical nutrition (SPP-1), individualized diet
- Where
- Russia
- Volunteers
- 45 people
- Sponsor
- Russian Academy of Medical Sciences
NASH - Nonalcoholic Steatohepatitis
Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately…
- Trial name
- ENDONASH (NCT04653311)
- Testing
- Endomina®
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Erasme University Hospital
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Non-alcoholic Steatohepatitis NASH
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
- Trial name
- NCT02913105
- Testing
- LMB763
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals