Clinical trials: Liver Fibrosis/NASH
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
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
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
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
Nonalcoholic Steatohepatitis
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.
- Trial name
- CENTAUR (NCT02217475)
- Testing
- Cenicriviroc
- Where
- 91 sites in United States, Australia and 8 more
- Volunteers
- 289 people
- Sponsor
- Tobira Therapeutics, Inc.
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
Nonalcoholic Steatohepatitis
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M…
- Trial name
- FORTUNA (NCT05809934)
- Testing
- AZD2693
- Where
- 163 sites in United States, Argentina and 20 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
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 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 (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
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.
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 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
Safety and Tolerability
A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects
This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult…
- Trial name
- NCT03809052
- Testing
- GB1211
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Galecto Biotech AB
Nonalcoholic Steatohepatitis
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
- Trial name
- AURORA (NCT03028740)
- Testing
- Cenicriviroc
- Where
- 346 sites in United States, Australia and 26 more
- Volunteers
- 1,778 people
- Sponsor
- Tobira Therapeutics, Inc.
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 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
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 Cirrhosis
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis…
- Trial name
- NCT04048876
- Testing
- CC-90001
- Where
- 142 sites in United States, Australia and 8 more
- Volunteers
- 56 people
- Sponsor
- Celgene
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