Clinical trials: NAFLD and NASH
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
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
Healthy
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06835919 in healthy adult Japanese participants.
- Trial name
- NCT04427917
- Testing
- PF-06835919
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Plaque Psoriasis, Non-alcoholic Fatty Liver Disease
A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
The aim of this study was to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic…
- Trial name
- pINPOINt (NCT04237116)
- Testing
- Investigational Arm - secukinumab
- Where
- 8 sites in Germany, Spain
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
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.
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo
- Trial name
- NCT02605616
- Testing
- AZ compound
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- University of Alabama at Birmingham
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
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD)
Tesamorelin Effects on Liver Fat and Histology in HIV
Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection.
- Conditions
- Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT02196831
- Testing
- tesamorelin
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- Massachusetts General Hospital
Nonalcoholic Fatty Liver Disease (NAFLD), Type 2 Diabetes (T2DM)
Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).
- Trial name
- NCT03459079
- Testing
- Lanifibranor
- Where
- United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- University of Florida
Fatty Liver
Polyunsaturated Fatty Acids (PUFA) in Diabetic Fatty Liver
Non-alcoholic steatohepatitis (NASH), the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease (NAFLD), has emerged as the major cause of chronic liver disease in developed countries.
- Trial name
- NCT00323414
- Testing
- Polyunsaturated fatty acid (Opti-EPA)
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Fatty Liver Disease, Nonalcoholic
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons.
- Trial name
- NCT00596934
- Testing
- metreleptin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Elif Oral
Fatty Liver, Nutritional and Metabolic Disease
Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with…
- Trial name
- LGI-NAFLD (NCT04415632)
- Testing
- low glycemic index diet, High glycemic index diet
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University of Nottingham
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 in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
Non Alcoholic Steatohepatitis, Fibrosis
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis.
- Trial name
- NCT04669158
- Testing
- Idebenone
- Where
- 2 sites in United States
- Volunteers
- 53 people
- Sponsor
- Stanford University
Liver Diseases, Blood Disorder
NASH Fitness Intervention in Thrombosis Trial (NASHFit)
Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival.
- Conditions
- Liver Diseases, Blood Disorder, Digestive System Disease
- Trial name
- NCT03518294
- Testing
- Aerobic Exercise
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Milton S. Hershey Medical Center
Iron, Diabetes
Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with diabetes such as fatty liver disease.
- Conditions
- Iron, Diabetes, Nonalcoholic Fatty Liver
- Trial name
- NCT03696797
- Testing
- Blood Donation
- Where
- 2 sites in United States
- Volunteers
- 132 people
- Sponsor
- Wake Forest University Health Sciences
Non-alcoholic Fatty Liver Disease
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass…
- Trial name
- NCT01654549
- Testing
- H.pylori eradication
- Where
- Iran
- Volunteers
- 40 people
- Sponsor
- Tehran University of Medical Sciences
Morbid Obesity, Obstructive Sleep Apnea Syndrome
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01045499
- Testing
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Jeffrey L Zitsman, MD