Clinical trials: Liver Fibrosis/NASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver…
- Trial name
- NCT07631637
- Testing
- ALN-CIDEB
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Regeneron Pharmaceuticals
MASLD
Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II clinical trial that consists of two parts.
- Trial name
- NCT07024212
- Testing
- DR10624 Injection
- Where
- 4 sites in China, Hong Kong
- Volunteers
- 110 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Fatty Liver, Non-Alcoholic Steatohepatitis
A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic…
- Conditions
- Fatty Liver, Non-Alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses
- Trial name
- Aramchol_005 (NCT02279524)
- Testing
- Aramchol
- Where
- 78 sites in United States, Chile and 9 more
- Volunteers
- 247 people
- Sponsor
- Galmed Research and Development, Ltd.
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics 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
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
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are: To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or…
- Trial name
- ATLAS (NCT03449446)
- Testing
- SEL, FIR, CILO
- Where
- 101 sites in United States, Australia and 4 more
- Volunteers
- 395 people
- Sponsor
- Gilead Sciences
NASH
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT05327127
- Testing
- K-877-ER, CSG452
- Where
- 77 sites in United States, Argentina and 4 more
- Volunteers
- 228 people
- Sponsor
- Kowa Research Institute, 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
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-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
Liver Diseases, Primary Biliary Cirrhosis
Repeatability and Reproducibility of Multiparametric MRI
This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS…
- Conditions
- Liver Diseases, Primary Biliary Cirrhosis, Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
- Trial name
- NCT03743272
- Testing
- LiverMultiScan
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Perspectum
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-alcoholic Steatohepatitis, Liver Diseases
Assessing Kids for Liver Inflammation and Fibrosis Using Non-invasive MRI
This is a prospective observational study which will recruit up to 100 paediatric participants over a period of 30 months to determine whether MRI is as accurate at detecting, distinguishing, and monitoring liver disease as…
- Conditions
- Non-alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses, Autoimmune Hepatitis
- Trial name
- Kids4LIFe (NCT03198104)
- Testing
- MRI
- Where
- Poland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Perspectum
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 Given to Healthy Participants
This is a study of experimental medication BMS-986036 given to healthy participants.
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03445208
- Testing
- BMS-986036
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
NASH With Fibrosis, NAFLD
AGED Diagnostics Liver Disease Assessment
Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood.
- Conditions
- NASH With Fibrosis, NAFLD, Healthy
- Trial name
- AGEDDX (NCT06348563)
- Testing
- AGED Multiple Target Assay in Healthy Controls, AGED Multiple Target Assay in NAFLD Participants, AGED Multiple Target Assay in Fibrosis Participants
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
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
HIV, HIV-Infections
The Visceral Adiposity Measurement and Observation Study
The Visceral Adiposity Measurement and Observation Study
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection
- Trial name
- VAMOS (NCT05383456)
- Testing
- Diagnostic Test, HIV Anti-retroviral Background Therapy
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Theratechnologies