Clinical trials: NASH
NASH - Nonalcoholic Steatohepatitis, Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X…
- Trial name
- NCT03976687
- Testing
- EYP001a
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
- Conditions
- Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- EMMINENCE (NCT02784444)
- Testing
- MSDC-0602K
- Where
- 43 sites in United States
- Volunteers
- 392 people
- Sponsor
- Cirius Therapeutics, Inc.
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02856555
- Testing
- Firsocostat
- Where
- 36 sites in United States
- Volunteers
- 127 people
- Sponsor
- Gilead Sciences
Non-alcoholic Steatohepatitis (NASH)
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with NAFLD and NASH.
- Trial name
- NCT02927314
- Testing
- CF102
- Where
- 3 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Can-Fite BioPharma
Non-alcoholic Steatohepatitis (NASH)
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
- Trial name
- NCT02316717
- Testing
- IMM-124E
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 133 people
- Sponsor
- Immuron Ltd.
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis
- Trial name
- NCT04255069
- Testing
- Dose 1 JKB-122, Dose 2 JKB-122
- Volunteers
- 300 people
- Sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
NASH - Nonalcoholic Steatohepatitis, NAFLD
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAFLD, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT03291249
- Testing
- Foralumab, Omeprazole 20mg
- Sponsor
- Tiziana Life Sciences LTD
NASH
Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.
- Trial name
- NCT02923154
- Testing
- MT-3995
- Where
- 2 sites in Japan
- Volunteers
- 48 people
- Sponsor
- Tanabe Pharma Corporation
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
NASH - Nonalcoholic Steatohepatitis
A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of EDP 305 on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Adult Female Subjects
- Trial name
- NCT03783897
- Testing
- EDP-305, Oral Contraceptive
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages…
- Trial name
- NCT02466516
- Testing
- SEL, SIM
- Where
- 28 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis (NASH)
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02854605
- Testing
- GS-9674
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 140 people
- Sponsor
- Gilead Sciences
Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver
Hepaxa Management of Non-alcoholic Fatty Liver Disease
This study measures the steatosis in patients With fatty livers as determined by CAP score from a fibroscan assessment. The study attempts to determine the effect of using the Medical Food Hepaxa in a Clinical setting Close to…
- Conditions
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Trial name
- NCT03801577
- Testing
- Hepaxa
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- BASF AS
NASH - Nonalcoholic Steatohepatitis
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human…
- Trial name
- NCT03610945
- Testing
- Fluconazole, Quinidine, EDP-305
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
NASH - Nonalcoholic Steatohepatitis
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
- Trial name
- NCT03748628
- Testing
- EDP-305
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-alcoholic Steatohepatitis, Chronic Liver Disease
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive…
- Conditions
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis
- Trial name
- ELEVATE (NCT00678587)
- Testing
- Eltrombopag
- Where
- 107 sites in United States, Argentina and 11 more
- Volunteers
- 292 people
- Sponsor
- GlaxoSmithKline
NASH
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
- Trial name
- NCT03207425
- Testing
- EDP 305
- Where
- 3 sites in United States, Czechia and 1 more
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc