Clinical trials: Non Alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcoholic Steatohepatitis, Fibrosis
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist.
- Conditions
- Non-alcoholic Steatohepatitis, Fibrosis, Liver Diseases
- Trial name
- ENCORE-NF (NCT02686762)
- Testing
- Emricasan (5 mg), Emricasan (50 mg)
- Where
- 103 sites in United States, Germany and 1 more
- Volunteers
- 318 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-Alcoholic Fatty Liver
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an…
- Trial name
- NCT03953456
- Testing
- elafibranor 120mg
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Genfit
Non-alcoholic Fatty Liver Disease
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.
- Trial name
- NCT01431521
- Testing
- MK-4074 200 mg, Pioglitazone hydrochloride 30 mg
- Volunteers
- 31 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Serum Levels of ALAT Transaminases, Serum Markers for Fibrosis and Hepatic Inflammation
Pilot Study of Ursodesoxycholic Acid in Non-Alcoholic Steatohepatitis
This is a phase II study with direct individual benefit. It is a randomized, double blind placebo controlled study whose aim is to evaluate the efficacy and tolerance of ursodesoxycholic acid in patients who have been diagnosed…
- Trial name
- URSONASH (NCT00470171)
- Testing
- Ursodesoxycholic acid
- Where
- France
- Volunteers
- 98 people
- Sponsor
- Axcan Pharma
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-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study in Participants With Non-cirrhotic NASH With Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and…
- Trial name
- COSMOS (NCT05638737)
- Testing
- AZD4831
- Where
- 65 sites in United States, Argentina and 7 more
- Volunteers
- 112 people
- Sponsor
- AstraZeneca
Healthy Volunteers
Multiple Ascending Dose and DDI Study
Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design.
- Trial name
- NCT03031119
- Testing
- PF-06835919, atorvastatin
- Where
- Belgium
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcoholic Steatohepatitis
A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT05766709
- Testing
- NNC0194-0499, Semaglutide, NNC0194-0499/Semaglutide A (40/3.20 mg/mL)
- Where
- Canada
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
This clinical study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in adult patients with non-alcoholic fatty liver disease (NAFLD) who manifest a…
- Trial name
- NEXSCOT (NCT04147195)
- Testing
- LYS006, Tropifexor
- Where
- 10 sites in United States, Argentina and 1 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Decompensated Cirrhosis
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new…
- Trial name
- ENCORE-LF (NCT03205345)
- Testing
- Emricasan (25 mg), Emricasan (5 mg)
- Where
- 76 sites in United States
- Volunteers
- 210 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-alcholic Fatty Liver Disease
Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition.
- Trial name
- NCT02068339
- Testing
- Oltipraz 1 (90mg), Oltipraz 2 (120mg)
- Where
- 5 sites in South Korea
- Volunteers
- 283 people
- Sponsor
- PharmaKing
Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver
A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects…
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Fibrosis, Liver, NAFLD
- Trial name
- ASCEND (NCT05402371)
- Testing
- Rencofilstat
- Where
- 41 sites in United States, France and 1 more
- Volunteers
- 120 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
Non-alcoholic Steatohepatitis
Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).
- Trial name
- NCT05016882
- Testing
- NNC0194 0499 50 mg/mL, Semaglutide 3 mg/mL, NNC0174 0833 10 mg/mL
- Where
- 255 sites in United States, Australia and 22 more
- Volunteers
- 698 people
- Sponsor
- Novo Nordisk A/S
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)
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.
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Overweight and Obesity, Type2 Diabetes
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
This is a Phase 1, first in human (FiH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to investigate the safety, tolerability, PK and PD of DD01 administered by…
- Conditions
- Overweight and Obesity, Type2 Diabetes, NAFLD
- Trial name
- NCT04812262
- Testing
- DD01
- Where
- 4 sites in United States, Puerto Rico
- Volunteers
- 255 people
- Sponsor
- Neuraly, Inc.
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.