Clinical trials: Hepatobiliary Disorders
NAFLD
The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease
The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.
- Trial name
- NCT02546609
- Testing
- Leu-Met-Sil 0.5, Leu-Met-Sil 1.0
- Where
- 13 sites in United States
- Volunteers
- 91 people
- Sponsor
- NuSirt Biopharma
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04906421
- Testing
- TVB-2640
- Where
- 117 sites in United States, Canada and 2 more
- Volunteers
- 168 people
- Sponsor
- Sagimet Biosciences Inc.
MASLD, MASH
Endoscopic Ultrasound Shear Wave Elastography Study
This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices.
- Conditions
- MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease
- Trial name
- EUS-SWE (NCT06592820)
- Testing
- Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, FibroScan, Liver biopsy
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Olympus Corporation of the Americas
Non-Alcoholic Fatty Liver Disease, Liver Disease; Alcohol-Related
FibroScan-Reproducibility and Repeatability Study
Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis.
- Trial name
- FibroScan-RR (NCT06877026)
- Testing
- FibroScan, Liver Enzymes
- Where
- United Kingdom
- Volunteers
- 108 people
- Sponsor
- Echosens
NASH - Nonalcoholic Steatohepatitis
Ascending Dose Study of HU6 in Healthy Volunteers
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next…
- Trial name
- NCT04463017
- Testing
- HU6
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Rivus Pharmaceuticals, Inc.
Healthy Volunteers, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug…
- Trial name
- NCT05648214
- Testing
- ALN-PNP
- Where
- 6 sites in United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Thrombocytopenia Associated With Liver Disease
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease.
- Trial name
- NCT01976104
- Testing
- avatrombopag (lower baseline platelet count), avatrombopag (higher baseline platelet count)
- Where
- 120 sites in United States, Argentina and 15 more
- Volunteers
- 204 people
- Sponsor
- Eisai Inc.
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
Non-alcoholic Fatty Liver Disease (NAFLD)
Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease
This short-term, randomized, placebo-controlled, investigator-initiated trial aims to establish metabolic improvements in NAFLD subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate…
- Trial name
- NAFLD (NCT04330326)
- Testing
- Metabolic Cofactor Supplementation, Sorbitol
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people
- Sponsor
- ScandiBio Therapeutics 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.
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
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Chronic Liver Disease
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
- Trial name
- MBT (NCT00736840)
- Testing
- c13 methacetin solution with breath analyzer
- Where
- 11 sites in United States, Israel
- Volunteers
- 414 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatic Cirrhosis
Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers
A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)
- Trial name
- NCT00856713
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Norgine
NASH (Non-Alcoholic Steatohepatitis)
Vitamin E Versus Placebo for the Treatment of Non Diabetic Patients With Nonalcoholic Steatohepatitis
VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in non diabetic adults with NASH compared to treatment with placebo in…
- Trial name
- NCT02962297
- Testing
- Vitamin E softgel
- Where
- 15 sites in China
- Volunteers
- 120 people
- Sponsor
- Zhejiang Medicine Co., Ltd.
Non-Alcoholic Steatohepatitis(NASH)
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity.
- Trial name
- NCT00706537
- Testing
- Active treatment
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pfizer
Liver Disease
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.
- Trial name
- NCT04408937
- Testing
- triopifexor
- Where
- 10 sites in United States
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
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
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
- Trial name
- NCT06108219
- Testing
- Miricorilant (Cohort A), Miricorilant (Cohort B)
- Where
- 77 sites in United States, India and 1 more
- Volunteers
- 175 people
- Sponsor
- Corcept Therapeutics