Clinical trials: Steatohepatitis
NASH
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high…
- Trial name
- NCT04048135
- Testing
- Pegozafermin
- Where
- 26 sites in United States, Puerto Rico
- Volunteers
- 101 people
- Sponsor
- 89bio, Inc.
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
Nonalcoholic Fatty Liver Disease, NAFLD
Rifaximin in Fatty Liver Disease
TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Open-label pilot study HYPOTHESIS Reduction in gut flora by the antibiotic Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH).
- Conditions
- Nonalcoholic Fatty Liver Disease, NAFLD, Nonalcoholic Steatohepatitis
- Trial name
- RiFL (NCT01355575)
- Testing
- Rifaximin
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Imperial College London
Non-alcoholic Steatohepatitis
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy.
- Trial name
- NCT03969719
- Testing
- PF-06835919
- Where
- 106 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)
Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation.
- Conditions
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
- Trial name
- NCT00994682
- Testing
- Pioglitazone study drug, Pioglitazone Open Label
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- University of Florida
Nonalcoholic Fatty Liver Disease
Role of Exenatide in NASH-a Pilot Study
We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.
- Trial name
- NAFLD (NCT00650546)
- Testing
- Exenatide
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Indiana University
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Trial name
- NCT06052566
- Testing
- Efinopegdutide
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
NASH - Nonalcoholic Steatohepatitis
A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed…
- Trial name
- NCT03551522
- Testing
- Seladelpar
- Where
- 14 sites in United States
- Volunteers
- 181 people
- Sponsor
- Gilead Sciences
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
- Trial name
- Harmony (NCT04767529)
- Testing
- Efruxifermin
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 128 people
- Sponsor
- Akero Therapeutics, Inc
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Familial Partial Lipodystrophy, Hypertriglyceridemia
Study of Gemcabene in Adults With FPLD
The overall objective of this study is to assess the efficacy and safety of two dosing regimens of gemcabene (300 mg once daily for 24 weeks or 300 mg daily for 12 weeks followed by 600 mg daily for 12 weeks) in up to eight…
- Conditions
- Familial Partial Lipodystrophy, Hypertriglyceridemia, Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Trial name
- NCT03508687
- Testing
- 300mg Gemcabene, 600mg Gemcabene
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Elif Oral
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
Polycystic Ovarian Syndrome, Obesity
Post-Prandial Liver Glucose Metabolism in PCOS
The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.
- Conditions
- Polycystic Ovarian Syndrome, Obesity, Hepatic Steatosis
- Trial name
- PLUM (NCT03041129)
- Testing
- oral glucose tolerance test, MRI of liver
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Familial Partial Lipodystrophy
Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications.
- Trial name
- NCT02430077
- Testing
- Obeticholic Acid
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Abhimanyu Garg
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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.
NASH - Nonalcoholic Steatohepatitis
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination…
- Trial name
- NCT03294941
- Testing
- HepQuant SHUNT Liver Diagnostic Kit
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- HepQuant, LLC
Morbid Obesity, Liver Fat
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes.
- Trial name
- LCD (NCT02144597)
- Testing
- Liquid formula low-calorie diet (LCD), Roux-en-Y gastric bypass (RYGB), Control diet
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Imperial College London
Nonalcoholic Steatohepatitis
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on…
- Trial name
- CONTROL (NCT02633956)
- Testing
- Obeticholic Acid, Atorvastatin
- Where
- 22 sites in United States
- Volunteers
- 84 people
- Sponsor
- Intercept Pharmaceuticals