Clinical trials: Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Condition Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Funder type Industry (pharma, biotech, devices)
NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period.
- Trial name
- VOYAGE (NCT04173065)
- Testing
- VK2809
- Where
- 79 sites in United States, Belgium and 3 more
- Volunteers
- 248 people
- Sponsor
- Viking Therapeutics, Inc.
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.
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Liver Diseases, Liver Cirrhosis
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other…
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- Trial name
- POCUS-NASH (NCT05120557)
- Testing
- Ultrasound liver assessment
- Volunteers
- 1,000 people
- Sponsor
- E-Scopics
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 (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
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.
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
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Non Alcoholic Steatohepatitis (NASH)
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic…
- Trial name
- REGENERATE (NCT02548351)
- Testing
- Obeticholic Acid
- Where
- 346 sites in United States, Australia and 19 more
- Volunteers
- 2,477 people
- Sponsor
- Intercept Pharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
NASH, Cirrhosis, Liver
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical…
- Trial name
- NCT05500222
- Testing
- Resmetirom
- Where
- 141 sites in United States, Belgium and 7 more
- Volunteers
- 845 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
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.
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
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
Healthy Participants
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects
This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
- Trial name
- NCT05604287
- Testing
- ID119031166M
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
Nonalcoholic Steatohepatitis
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of…
- Trial name
- NASH-FX (NCT02421094)
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galectin Therapeutics Inc.