Clinical trials: Hepatobiliary Disorders
Non-Alcoholic Steatohepatitis
Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic…
- Trial name
- NCT03962608
- Testing
- Yaq-001
- Where
- 9 sites in France, Italy and 4 more
- Sponsor
- Yaqrit Ltd
Nonalcoholic Fatty Liver Disease
A Phase 1a/1b Study of CB4211 in Healthy Non-obese Subjects and Subjects With Nonalcoholic Fatty Liver Disease
This is a 3 part, randomized, double blind, placebo controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending subcutaneous (SC) doses of CB4211 in…
- Trial name
- NCT03998514
- Testing
- CB4211 Dose 1, CB4211 Dose 2, CB4211 Dose 3
- Where
- 4 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- CohBar, Inc.
Non-Alcoholic Fatty Liver Disease
A Clinical Trial to Evaluate the Efficacy and Safety of MXP22 on Liver Health
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
- Trial name
- NCT05808049
- Testing
- MXP22 (Probiotic and antioxidant capsule)
- Where
- 2 sites in India
- Volunteers
- 60 people
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Type 2 Diabetes
A Study to Identify the Risk of Non-alcoholic Fatty Liver Disease (NAFLD) in Patients With Type 2 Diabetes in Clinical Practice and to Evaluate the Clinical Usefulness of Dapagliflozin/Pioglitazone Combination Therapy
The purpose of this study is to identify the risk of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes in clinical practice and to evaluate the clinical usefulness of Dapagliflozin/Pioglitazone…
- Trial name
- NCT06649162
- Where
- 2 sites in South Korea
- Volunteers
- 10,000 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
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 Fatty Liver Disease, Nonalcoholic Steatohepatitis
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT03248882
- Testing
- PF-05221304
- Where
- 140 sites in United States, Australia and 4 more
- Volunteers
- 305 people
- Sponsor
- Pfizer
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Non-alcoholic Fatty Liver Disease (NAFLD)
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).
- Trial name
- NCT01811472
- Testing
- LCQ908
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Type 2 Diabetes Mellitus in Remission, Metabolic Associated Fatty Liver Disease
Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China
In 2019, the number of patients with diabetes was about 463 million in the world, accounting for 8.3% of the total population, and it is expected to rise to 578 million (9.2%) by 2030 and 700 million (9.6%) by 2045.
- Trial name
- NCT05597709
- Testing
- Ultrasound attenuation parameter measurement, fasting blood glucose and fasting insulin determination
- Where
- China
- Volunteers
- 2,900 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
Alcoholic Hepatitis
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).
- Trial name
- AHFIRM (NCT04563026)
- Testing
- DUR-928 30 mg, DUR-928 90 mg
- Where
- 68 sites in United States, Australia and 4 more
- Volunteers
- 307 people
- Sponsor
- Durect
Chronic Hepatitis C
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV).
- Trial name
- NCT00962936
- Testing
- CT-011
- Where
- Israel
- Volunteers
- 13 people
- Sponsor
- CureTech Ltd
Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of Non-alcoholic fatty Liver disease (NAFLD) and/or Non-alcoholic steatohepatitis (NASH).
- Trial name
- EVIDENCES IV (NCT03061721)
- Testing
- Saroglitazar magnesium 1 mg, Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 18 sites in United States
- Volunteers
- 106 people
- Sponsor
- Zydus Therapeutics Inc.
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.
Nonalcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver Disease
Phase 2b Study of GSK4532990 in Adults With NASH
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4).
- Trial name
- HORIZON (NCT05583344)
- Testing
- GSK4532990
- Where
- 170 sites in United States, Argentina and 15 more
- Volunteers
- 284 people
- Sponsor
- GlaxoSmithKline
Chronic Liver Disease
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
The objectives of this study are: To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT…
- Trial name
- NCT02084160
- Where
- 4 sites in United States, Israel
- Volunteers
- 579 people
- Sponsor
- Meridian Bioscience, Inc.
Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
2-Week Study In People With Nonalcoholic Fatty Liver Disease
2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.
- Trial name
- NCT03513588
- Testing
- PF-06865571
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis
Dose Escalation Study of Kylo-0603 in Healthy Subjects
This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of…
- Trial name
- NCT06365580
- Testing
- Kylo-0603 capsule
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Kylonova (Xiamen) Biopharma co., LTD.
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
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 Fatty Liver Disease
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
- Trial name
- ZENITH-2 (NCT07221188)
- Testing
- Efimosfermin Alfa
- Where
- 66 sites in United States, Australia and 6 more
- Volunteers
- 1,250 people
- Sponsor
- GlaxoSmithKline