Clinical trials: Hepatobiliary Disorders
Nonalcoholic Steatohepatitis (NASH)
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT04521114)
- Testing
- leronlimab 700 mg, leronlimab 350 mg
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- CytoDyn, Inc.
Mild Hepatic Encephalopathy
AST-120 Used to Treat Mild Hepatic Encephalopathy
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Trial name
- ASTUTE (NCT00867698)
- Testing
- AST-120
- Where
- 38 sites in United States
- Volunteers
- 148 people
- Sponsor
- Ocera Therapeutics
Non-Alcoholic Steatohepatitis
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)
- Trial name
- NCT03400163
- Testing
- BMS-986036
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Nonalcoholic Fatty Liver Disease
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
- Trial name
- SARONAPLUS (NCT05211284)
- Testing
- Saroglitazar Magnesium 4 mg
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Zydus Therapeutics Inc.
Chronic Liver Disease
Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
Primary objectives: To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated…
- Trial name
- GRI-201 (NCT02949375)
- Testing
- Active Comparator:4.5mg GRI-0621, Active Comparator: 6.0mg GRI-0621
- Where
- South Africa
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GRI Bio Operations, Inc.
Overweight and Obesity
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its…
- Trial name
- CONTEMPO (NCT06151964)
- Testing
- AZD9550, AZD9550 and AZD6234
- Where
- 15 sites in Austria, Canada and 3 more
- Volunteers
- 166 people
- Sponsor
- AstraZeneca
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
This study is open to adults who are at least 18 years old living with obesity and have: a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and moderate or advanced…
- Trial name
- NCT06632444
- Testing
- Survodutide
- Where
- 532 sites in United States, Argentina and 35 more
- Volunteers
- 1,800 people
- Sponsor
- Boehringer Ingelheim
Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
This single arm interventional cohort study is designed to explore the feasibility of using BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with NAFLD or NASH over a 3 month intervention.
- Conditions
- Non-alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver
- Trial name
- NCT05357248
- Testing
- BT-NCBT-00X
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Better Therapeutics
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatic Impairment, Liver Disease
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment.
- Conditions
- Hepatic Impairment, Liver Disease, Pharmacokinetics
- Trial name
- NCT03765671
- Testing
- Elafibranor
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genfit
Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
- Trial name
- NCT04004325
- Testing
- FT-4101, Deuterated Water
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Forma Therapeutics, Inc.
Non Alcoholic Fatty Liver Disease
Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)
A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non…
- Trial name
- NCT01511523
- Testing
- RGMA001, Sugar Pill
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Biovil Research Group, LLC
Hepatobiliary Disorders, Non-alcoholic Steatohepatitis
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis
- Trial name
- NCT02970942
- Testing
- Semaglutide
- Where
- 158 sites in United States, Australia and 15 more
- Volunteers
- 320 people
- Sponsor
- Novo Nordisk A/S
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.
Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH).
- Conditions
- Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, NAFLD, Metabolic Dysfunction-associated Steatotic Liver Disease
- Trial name
- NCT06465186
- Testing
- Efinopegdutide
- Where
- 68 sites in United States, Australia and 9 more
- Volunteers
- 85 people
- Sponsor
- Merck Sharp & Dohme LLC
Intestinal Failure Associated Liver Disease
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated…
- Trial name
- NCT05919680
- Testing
- NST-6179 Part A, NST-6179 Part B
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- NorthSea Therapeutics B.V.
Non-alcoholic Fatty Liver Disease
A Study to Compare MitoQ and Placebo to Treat Non-alcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to investigate whether a new medicine, called mitoquinone, will reduce raised liver enzymes due to NAFLD and to see if it is safe.
- Trial name
- MARVEL (NCT01167088)
- Testing
- Mitoquinone mesylate
- Where
- United Kingdom
- Volunteers
- 110 people
- Sponsor
- Antipodean Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
NASH - Nonalcoholic Steatohepatitis
Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human…
- Trial name
- NCT03213145
- Testing
- intraconazole, Rifampin, EDP 305
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-alcoholic Steatohepatitis
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in participants with biopsy-proven Non-alcoholic Steatohepatitis (NASH).
- Trial name
- NCT02912260
- Testing
- MGL-3196
- Where
- 26 sites in United States
- Volunteers
- 125 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.