Clinical trials: NAFLD and NASH
Nonalcoholic Fatty Liver
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
- Trial name
- NCT03763877
- Testing
- PXL770
- Where
- 15 sites in United States
- Volunteers
- 121 people
- Sponsor
- Poxel SA
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
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.
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
Non-alcoholic Steatohepatitis
Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects…
- Trial name
- SyNCH (NCT00680407)
- Testing
- Silymarin 700 mg, Silymarin 420 mg
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- Madaus Inc
HIV Infections, Non-Alcoholic Fatty Liver Disease
Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
The purpose of this study was to evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis.
- Trial name
- NCT04216589
- Testing
- Semaglutide
- Where
- 9 sites in United States, Brazil
- Volunteers
- 51 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
Non-Alcoholic Fatty Liver Disease, Hepatitis B
A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada
(1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD in Canada do not have immunity to hepatitis B.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Hepatitis B, Vaccine Reaction
- Trial name
- NCT02985450
- Testing
- Engerix-B
- Where
- Canada
- Volunteers
- 82 people
- Sponsor
- University of Calgary
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
Fatigue
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue. Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3…
- Trial name
- NCT02331589
- Testing
- KRG (Korea Red ginseng)
- Volunteers
- 75 people
- Sponsor
- Chuncheon Sacred Heart Hospital
NAFLD, Diabetes Mellitus, Type 2
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Conditions
- NAFLD, Diabetes Mellitus, Type 2, Hypertriglyceridemia, Fatty Liver, Nonalcoholic
- Trial name
- NCT03371355
- Testing
- ISIS 703802 40 mg, ISIS 703802 80 mg, ISIS 703802 20 mg
- Where
- 42 sites in United States, Canada
- Volunteers
- 105 people
- Sponsor
- Akcea Therapeutics
Non-Alcoholic Fatty Liver Disease
Investigation of Synbiotic Treatment in NAFLD
Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the liver not caused by alcohol. The liver is an organ that is not designed to build up fat.
- Trial name
- INSYTE (NCT01680640)
- Testing
- Synbiotic, Maltodextrin
- Where
- United Kingdom
- Volunteers
- 104 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Nonalcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
The primary aim of the study is to determine the impact on hepatic steatosis of replacing premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting detemir (Levemir) insulin in well-controlled…
- Trial name
- NCT01006889
- Testing
- Exenatide
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Florida
Non-Alcoholic Fatty Liver Disease, Obesity
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal, Liver Fat
- Trial name
- NCT03375788
- Testing
- Tesamorelin
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
Non-Alcoholic Fatty Liver Disease
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic…
- Trial name
- NCT01285362
- Testing
- Fish Oil Supplementation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Non-Alcoholic Fatty Liver Disease, Obesity
Alternate Day Fasting, Exercise, and NAFLD
Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes.
- Trial name
- NCT04004403
- Testing
- Alternate day fasting, Exercise
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease
Alternate Dosing Study of MK-6024 in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (MK-6024-016)
This study will evaluate the effect of efinopegdutide administration once every 2 weeks (Q2W) versus once weekly (Q1W) on mean relative reduction from baseline in liver fat content (LFC) after 28 weeks, as well as the safety and…
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, Liver Disease
- Trial name
- NCT06482112
- Testing
- Efinopegdutide
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 124 people
- Sponsor
- Merck Sharp & Dohme LLC