Clinical trials: Nash
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
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with…
- Trial name
- EFFECTII (NCT02279407)
- Testing
- Omega-3 carboxylic acids, Dapagliflozin
- Where
- 5 sites in Sweden
- Volunteers
- 223 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
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
Hepatocellular Carcinoma, Nonalcoholic Steatohepatitis
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver.
- Trial name
- NCT04550481
- Testing
- Biospecimen Collection, Lisinopril, Liver Ultrasonographic Elastography
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese…
- Trial name
- NCT04019561
- Testing
- MEDI0382 high dose, MEDI0382 low dose
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 74 people
- Sponsor
- MedImmune LLC
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with…
- Trial name
- NCT06007651
- Testing
- LY3885125
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Eli Lilly and Company
Non-alcoholic Steatohepatitis
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in patients with NASH or suspected NASH.
- Trial name
- NCT04202354
- Testing
- ARO-HSD Injection, sterile normal saline (0.9% NaCl)
- Where
- New Zealand
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Sonoelastography: Ultrasound Method to Measure Liver Fibrosis
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, Hepatitis C Virus (HCV) Coinfection, Hepatitis B Virus (HBV)
- Trial name
- NCT01747772
- Testing
- Shear Wave Sonoelastography
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Massachusetts General Hospital
Nonalcoholic Fatty Liver Disease (NAFLD)
Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects with nonalcoholic fatty…
- Trial name
- NCT02244944
- Testing
- EZ-Urso combination therapy
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Gregory Graf, PhD
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
- Trial name
- NCT04618744
- Testing
- ORMD-0801 (Insulin) capsule 8 mg BD
- Where
- 3 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Oramed, Ltd.
Fatty Liver Disease, Fibrosis, Liver
Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis
This study will evaluate the effect of probiotics, a beneficial intestinal bacteria supplement, if it will cause improvement of the non-alcoholic fatty liver disease (NAFLD) and or non-alcoholic steatohepatitis (NASH- an…
- Conditions
- Fatty Liver Disease, Fibrosis, Liver, Cirrhosis, Liver, Steatohepatitis, Nonalcoholic
- Trial name
- PRONE (NCT04175392)
- Testing
- Align Probiotic Supplement Capsule
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corewell Health East
Nonalcoholic Steatohepatitis
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.
- Trial name
- NCT04583423
- Testing
- MK-3655
- Where
- 180 sites in United States, Argentina and 22 more
- Volunteers
- 183 people
- Sponsor
- Merck Sharp & Dohme LLC
NASH
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high…
- Trial name
- NCT04048135
- Testing
- Pegozafermin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- 89bio, Inc.
Non-alcoholic Fatty Liver Disease in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
NAFLD
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated.
- Trial name
- NCT04073407
- Testing
- AXA1957
- Where
- 4 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Non-alcoholic Fatty Liver Disease (NAFLD, Hypertriglyceridemia
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in 2 centres in Sweden to assess the effect of Omega-3 carboxylic acids and fenofibrate on liver fat measured with magnetic…
- Trial name
- NCT02354976
- Testing
- Omega-3 carboxylic acid, Fenofibrate 200mg
- Where
- 4 sites in Sweden
- Volunteers
- 78 people
- Sponsor
- AstraZeneca
Non-Alcoholic Fatty Liver Disease
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic…
- Trial name
- NCT01285362
- Testing
- Fish Oil Supplementation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive.
- Trial name
- Repro (NCT01579162)
- Testing
- Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
Non-Alcoholic Steatohepatitis
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
- Trial name
- NCT02287779
- Testing
- SHP626
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.