Clinical trials: Hepatobiliary Disorders
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with…
- Trial name
- NCT06007651
- Testing
- LY3885125
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Eli Lilly and Company
NAFLD - Nonalcoholic Fatty Liver Disease
Losartan for the Treatment of Pediatric NAFLD
A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
- Trial name
- STOP-NAFLD (NCT03467217)
- Testing
- Losartan potassium
- Where
- 10 sites in United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Chronic Liver Disease
The SHUNT-V Study for Varices
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.
- Trial name
- NCT03583996
- Testing
- HepQuant SHUNT Liver Diagnostic Test
- Where
- 26 sites in United States
- Volunteers
- 306 people
- Sponsor
- HepQuant, LLC
Overweight, Obese
The Effect of Protein-enriched Diet on Body Composition and Appetite
Obesity is a major problem worldwide and current dietary interventions are not proving to be enough to cease the increase in levels of obesity and its detrimental side effects, such as nonalcoholic fatty liver disease (NAFLD).
- Conditions
- Overweight, Obese, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease
- Trial name
- ProteinRich (NCT01634048)
- Testing
- High Protein, low calorie meal replacement
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Chronic Hepatitis c, Cirrhosis, Liver
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to…
- Conditions
- Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis
- Trial name
- HALT-C (NCT00006164)
- Testing
- Peginterferon alfa-2a + Ribavirin, Peginterferon alfa-2a
- Where
- 11 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Type II, Fatty Liver
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: The safety and tolerability of multiple doses of INT 747…
- Trial name
- NCT00501592
- Testing
- INT-747
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Intercept Pharmaceuticals
Nonalcoholic Fatty Liver Disease (NAFLD)
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United…
- Trial name
- NAFLD (NCT02217345)
- Testing
- Growth hormone
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- Massachusetts General Hospital
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with…
- Trial name
- EFFECTII (NCT02279407)
- Testing
- Omega-3 carboxylic acids, Dapagliflozin
- Where
- 5 sites in Sweden
- Volunteers
- 223 people
- Sponsor
- AstraZeneca
Oligometastatic Disease, Liver Metastases
Comparison of Contrast Agents in Liver Magnetic Resonance (MR) for the Detection of Hepatic Metastases
If an abbreviated hepatobiliary phase (HBP) protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal…
- Conditions
- Oligometastatic Disease, Liver Metastases, Colorectal Cancer
- Trial name
- NCT04973007
- Testing
- Gadoxetate disodium, Gadobenate dimeglumine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Colorado, Denver
Non-alcoholic Steatohepatitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Trial name
- BANFF (NCT04171765)
- Testing
- BFKB8488A
- Where
- 53 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- Genentech, Inc.
Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD)
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe…
- Conditions
- Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 1 (NCT03486899)
- Testing
- BMS-986036
- Where
- 89 sites in United States, Japan
- Volunteers
- 197 people
- Sponsor
- Bristol-Myers Squibb
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese…
- Trial name
- NCT04019561
- Testing
- MEDI0382 high dose, MEDI0382 low dose
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 74 people
- Sponsor
- MedImmune LLC
Hepatitis C, Hepatitis C, Chronic
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure
- Trial name
- A-WISH (NCT00135694)
- Testing
- calcineurin inhibitor-based immunosuppression, liver transplant, corticosteroids
- Where
- 8 sites in United States
- Volunteers
- 275 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Thrombocytopenia Associated With Liver Disease
Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing 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
- NCT01972529
- Testing
- avatrombopag (lower baseline platelet count), avatrombopag (higher baseline platelet count)
- Where
- 109 sites in United States, Argentina and 18 more
- Volunteers
- 231 people
- Sponsor
- Eisai Inc.
Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease
Octreotide in Severe Polycystic Liver Disease
This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection…
- Conditions
- Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver Diseases
- Trial name
- NCT00426153
- Testing
- Octreotide
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Mayo Clinic
Non-Alcoholic Steatohepatitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
- Trial name
- NCT03421431
- Testing
- EDP-305 Dose 1, EDP-305 Dose 2
- Where
- 82 sites in United States, Canada and 4 more
- Volunteers
- 134 people
- Sponsor
- Enanta Pharmaceuticals, Inc
NASH - Nonalcoholic Steatohepatitis
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
- Trial name
- NCT03611101
- Testing
- ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Meridian Bioscience, Inc.