Clinical trials: NASH (Non-Alcoholic Steatohepatitis)
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 - Nonalcoholic Steatohepatitis
Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
This is a prospective, open-label, multicenter, safety, comparative study of IV administered Tc99m-tilmanocept and unfiltered Tc99m sulfur colloid in the detection of and assessment of three dimensional tessellation localization…
- Trial name
- NCT03332940
- Testing
- Tc 99M Sulfur Colloid, Tc99m-tilmanocept
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Navidea Biopharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and…
- Trial name
- NCT04771273
- Testing
- Survodutide
- Where
- 154 sites in United States, Australia and 23 more
- Volunteers
- 295 people
- Sponsor
- Boehringer Ingelheim
Non-Alcoholic Steatohepatitis (NASH)
Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver…
- Trial name
- NCT06677788
- Testing
- Roflumilast 500 Mcg Oral Tablet, Vitamin E capsule
- Where
- Egypt
- Volunteers
- 55 people
- Sponsor
- Tanta University
Non-alcoholic Fatty Liver Disease (NAFLD), NASH - Nonalcoholic Steatohepatitis
Integrated Phenotyping of the Gut-plAtelet-Liver AXIS in the Progression of Chronic Liver Disease (iGAL-AXIS)
Objective of the study Our working hypothesis is that platelets activated by gut-derived metabolites dock in the liver of NAFLD patients and amplify the inflammatory state by releasing pro-inflammatory cytokines/chemokines, which…
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Control Condition
- Trial name
- NCT06623084
- Testing
- Platelets characterization
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Stefania Basili
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 (NASH)
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
- Trial name
- NCT05118360
- Testing
- ASC41 2 mg, ASC41 4 mg
- Sponsor
- Gannex Pharma Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
- Trial name
- NCT04267393
- Testing
- BMS-986263
- Where
- 112 sites in United States, Argentina and 14 more
- Volunteers
- 124 people
- Sponsor
- Bristol-Myers Squibb
Nonalcoholic Steatohepatitis (NASH)
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT05117489
- Testing
- Miricorilant 150 mg, Miricorilant 100 mg, Miricorilant 50 mg
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- Corcept Therapeutics
Nonalcoholic Steatohepatitis (NASH)
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT05320146
- Testing
- MRI-PDFF
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Corcept Therapeutics
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
- Trial name
- NCT04618744
- Testing
- ORMD-0801 (Insulin) capsule 8 mg BD
- Where
- 3 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Oramed, Ltd.
NASH - Nonalcoholic Steatohepatitis
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks.
- Trial name
- NCT04697810
- Testing
- Namodenoson
- Where
- 24 sites in Bosnia and Herzegovina, Bulgaria and 4 more
- Volunteers
- 114 people
- Sponsor
- Can-Fite BioPharma
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
Non-alcoholic Steatohepatitis (NASH)
FTIH of ECC4703 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL
- Trial name
- NCT05552274
- Testing
- ECC4703
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Eccogene
NASH - Nonalcoholic Steatohepatitis
Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis
The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
- Trial name
- NCT05284448
- Testing
- pentoxifylline (Trental SR®)
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Al-Azhar University
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.
NASH - Nonalcoholic Steatohepatitis
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Trial name
- NCT04897594
- Testing
- TERN-201
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Nonalcoholic Steatohepatitis, NASH
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).
- Trial name
- NCT04565717
- Testing
- ALN-HSD
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
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.
PreDiabetes, Insulin Resistance
Disease Prevention in Clinical Practice Base on Patient Specific Physiology
It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years by metabolic dysfunction and anatomic changes that can be quantified.
- Conditions
- PreDiabetes, Insulin Resistance, Type2 Diabetes, NASH - Nonalcoholic Steatohepatitis
- Trial name
- STOPDISEASE (NCT03308773)
- Testing
- Lifestyle modification in routine care of patients
- Volunteers
- 5,000 people
- Sponsor
- Pacific Coast Family Medical Group