Clinical trials: NASH
Hepatitis
Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis, and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity, type 2 diabetes, and insulin resistance.
- Trial name
- NCT00063232
- Testing
- Metformin
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Non-alcoholic Fatty Liver Disease
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
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
- NCT01712711
- Testing
- H.pylori eradication
- Where
- Iran
- Volunteers
- 40 people
- Sponsor
- Tehran University of Medical Sciences
Non-Cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study in Participants With Non-cirrhotic NASH With Fibrosis
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Participants will be in the trial for up to 24 weeks, including a screening period lasting up to 8 weeks, a 12-week treatment period, and…
- Trial name
- COSMOS (NCT05638737)
- Testing
- AZD4831
- Where
- 65 sites in United States, Argentina and 7 more
- Volunteers
- 112 people
- Sponsor
- AstraZeneca
Hepatocellular Carcinoma, Nonalcoholic Steatohepatitis
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver.
- Trial name
- NCT04550481
- Testing
- Biospecimen Collection, Lisinopril, Liver Ultrasonographic Elastography
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Northwestern University
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
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.
Nonalcoholic Steatohepatitis
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of…
- Trial name
- NASH-FX (NCT02421094)
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galectin Therapeutics Inc.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Fatty Liver
Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease
The purpose of this study is to evaluate how the liver receives and uses fats for energy. This will help the investigators further understand the physical and chemical processes responsible for Non-Alcoholic Fatty Liver Disease…
- Trial name
- Liver (NCT00949403)
- Testing
- Radio pharmaceuticals C-11 Acetate, and C-11 Palmitate
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Washington University School of Medicine
Steatohepatitis
A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
The main aim of this study is to evaluate the safety and tolerability of ontamalimab in participants with a liver disease called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) with…
- Trial name
- NCT07052682
- Testing
- Ontamalimab
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Takeda
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
Non-alcoholic Fatty Liver Disease
Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.
- Trial name
- NCT03166735
- Testing
- BI 1467335
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 114 people
- Sponsor
- Boehringer Ingelheim
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
- Trial name
- NCT05039450
- Testing
- EFX
- Where
- 49 sites in United States, Mexico and 1 more
- Volunteers
- 213 people
- Sponsor
- Akero Therapeutics, Inc
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
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
NAFLD, Diabetes Mellitus
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes
The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke…
- Trial name
- NAFLD-DM (NCT05844137)
- Testing
- NAFLD Education, diet/lifestyle support, T2D medication management
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Duke University
Compliance Behavior
Beta Glucosylceramide for Treatment of NASH
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
- Trial name
- NCT02126306
- Testing
- Beta Glucosylceramide
- Volunteers
- 23 people
- Sponsor
- Hadassah Medical Organization
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
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