Clinical trials: Non Alcoholic Steatohepatitis
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)
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and…
- Trial name
- NCT06216041
- Testing
- IMM-H014, IMM-H014 ( FE)
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
NASH - Nonalcoholic Steatohepatitis
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination…
- Trial name
- NCT03294941
- Testing
- HepQuant SHUNT Liver Diagnostic Kit
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- HepQuant, LLC
Nonalcoholic Fatty Liver Disease
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
- Trial name
- NCT04766476
- Testing
- BMS-963272
- Where
- 19 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bristol-Myers Squibb
Metabolic Dysfunction-associated Steatohepatitis
A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)
The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in…
- Trial name
- NCT07288138
- Testing
- ECC4703, ECC0509
- Where
- 68 sites in United States
- Volunteers
- 160 people
- Sponsor
- Eccogene
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 With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Non-alcoholic Steatohepatitis
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy.
- Trial name
- NCT03969719
- Testing
- PF-06835919
- Where
- 106 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Pfizer
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
Non-alcoholic Steatohepatitis (NASH)
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in participants with…
- Trial name
- NCT04483947
- Testing
- AZD2693
- Where
- 16 sites in United States
- Volunteers
- 74 people
- Sponsor
- AstraZeneca
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.
Fatty Liver
The Effect of a Probiotic on Hepatic Steatosis
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States.
- Trial name
- NCT00099723
- Testing
- VSL#3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- VSL Pharmaceuticals
Nonalcoholic Steatohepatitis
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group.
- Trial name
- NCT01466894
- Testing
- IMM 124-E
- Sponsor
- Immuron Ltd.
NASH - Nonalcoholic Steatohepatitis
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo.
- Trial name
- NCT03468556
- Testing
- SNP-610
- Volunteers
- 80 people
- Sponsor
- Sinew Pharma Inc.
NAFLD
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
- Trial name
- NCT03261739
- Testing
- RYI-018
- Where
- 6 sites in United States, Australia and 1 more
- Volunteers
- 84 people
- Sponsor
- Bird Rock Bio, Inc.
Fatty Liver, Nonalcoholic, NAFLD
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
- Conditions
- Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03656744
- Testing
- HTD1801
- Where
- 17 sites in United States
- Volunteers
- 101 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Non-Alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)
To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.
- Trial name
- NCT04336800
- Testing
- LiverMultiscan
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Perspectum
Non-alcoholic Steatohepatitis (NASH)
Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
- Trial name
- FLIGHT-FXR (NCT02855164)
- Testing
- Tropifexor (LJN452)
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
Steatohepatitis, Nonalcoholic
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement…
- Trial name
- NCT04932512
- Testing
- ION224
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 160 people
- Sponsor
- Ionis Pharmaceuticals, Inc.