Clinical trials: NASH With Fibrosis
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
Hepatitis
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol.
- Trial name
- NCT00062764
- Testing
- Actos (Pioglitazone)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Fatty Liver, Nonalcoholic, Diabetes Mellitus, Type 2
Identification of Fatty Liver With Advanced Fibrosis in Type 2 Diabetes Using Simple Fibrosis Scores and Electronic Reminder Messages
Nonalcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide and is a major cause of cirrhosis and liver cancer in Western countries.
- Trial name
- NCT04241575
- Testing
- Simple fibrosis scores and electronic reminder messages
- Where
- Hong Kong
- Volunteers
- 1,061 people
- Sponsor
- Chinese University of Hong Kong
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
Non-Alcoholic Fatty Liver Disease
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS, yet there is presently no licensed treatment or validated approach to management.
- Trial name
- WELCOME (NCT00760513)
- Testing
- OMACOR
- Where
- United Kingdom
- Volunteers
- 103 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
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
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
Hypertension, Portal
Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis
Study GT 026 is a Phase 2, multicenter, parallel group, North American, randomized, placebo controlled, double blind study. This study will enroll subjects with portal hypertension (HVPG greater than or equal to 6 mm Hg) who also…
- Trial name
- NASH-CX (NCT02462967)
- Testing
- GR-MD-02
- Where
- 46 sites in United States
- Volunteers
- 162 people
- Sponsor
- Galectin Therapeutics Inc.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic…
- Trial name
- RESOLVE-IT (NCT02704403)
- Testing
- Elafibranor
- Where
- 326 sites in United States, Argentina and 23 more
- Volunteers
- 2,157 people
- Sponsor
- Genfit
Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
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
Nonalcoholic Steatohepatitis, Liver Cirrhosis
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203…
- Conditions
- Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
- Trial name
- NCT03059446
- Testing
- Cenicriviroc
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 167 people
- Sponsor
- Tobira Therapeutics, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Phase 2b Study in NASH to Assess IVA337
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common.
- Trial name
- NATIVE (NCT03008070)
- Testing
- IVA337
- Where
- 85 sites in United States, Australia and 14 more
- Volunteers
- 247 people
- Sponsor
- Inventiva Pharma
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
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-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
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)
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver…
- Trial name
- NCT01694849
- Testing
- GFT505 80mg, GFT505 120mg
- Where
- 56 sites in United States, Belgium and 7 more
- Volunteers
- 275 people
- Sponsor
- Genfit