A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT04849728
Recruiting
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Gender:
All
Ages:
18 years and above
Trial Updated:
11/21/2023
Locations: Pinnacle Research Group, Anniston, Alabama +492 locations
Conditions: NASH - Nonalcoholic Steatohepatitis
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Quantifying Body Composition and Liver Disease in Children Using Free-Breathing MRI and MRE
NCT04591106
Recruiting
Magnetic resonance imaging (MRI) is used to measure liver fat content and fatty tissues in the body, and magnetic resonance elastography (MRE) is used to measure liver stiffness. The information from MRI and MRE are used to understand risk factors and diagnose liver diseases, such as fatty liver disease and liver fibrosis. However, current MRI and MRE scans need to be performed during a breath-hold, which may be challenging or impossible in children and infants. The goal of this research project... Read More
Gender:
All
Ages:
Between 1 week and 40 years
Trial Updated:
11/17/2023
Locations: UCLA Medical Center, Los Angeles, California
Conditions: NAFLD, NASH - Nonalcoholic Steatohepatitis
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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
NCT05232071
Recruiting
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.
Gender:
All
Ages:
18 years and above
Trial Updated:
11/03/2023
Locations: Birmingham Digestive Health Research, Homewood, Alabama +43 locations
Conditions: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684
Recruiting
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 States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. The investigators hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation... Read More
Gender:
All
Ages:
Between 21 years and 60 years
Trial Updated:
10/24/2023
Locations: Massachusetts General Hospital, Boston, Massachusetts
Conditions: NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
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Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects
NCT04505436
Recruiting
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
Gender:
All
Ages:
Between 18 years and 70 years
Trial Updated:
10/23/2023
Locations: North Alabama GI Research Center, Madison, Alabama +51 locations
Conditions: NASH - Nonalcoholic Steatohepatitis
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Hepatic Energy Fluxes in NASH and NAS Patients
NCT03997422
Recruiting
Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver... Read More
Gender:
All
Ages:
Between 40 years and 67 years
Trial Updated:
09/13/2023
Locations: University of Minnesota, Minneapolis, Minnesota
Conditions: NASH - Nonalcoholic Steatohepatitis, NAS, Overweight or Obesity, Weight Loss, Bariatric Surgery Candidate
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Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
NCT04054310
Recruiting
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 & F≥2 from those without.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
09/07/2023
Locations: Arizona Liver Health, Chandler, Arizona +6 locations
Conditions: NASH - Nonalcoholic Steatohepatitis
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Tocotrienol Against the Progression of End Stage Liver Disease
NCT02581085
Recruiting
The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.
Gender:
All
Ages:
18 years and above
Trial Updated:
07/19/2023
Locations: IU Health Unviersity Hospital, Indianapolis, Indiana
Conditions: End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
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Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
NCT03587831
Recruiting
Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators... Read More
Gender:
All
Ages:
Between 30 years and 70 years
Trial Updated:
06/05/2023
Locations: University of San Fransisco, San Francisco, California +1 locations
Conditions: NASH - Nonalcoholic Steatohepatitis
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Estrogen Administration for the Treatment of NASH in Postmenopausal Women
NCT04833140
Recruiting
Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will exam... Read More
Gender:
Female
Ages:
Between 45 years and 70 years
Trial Updated:
04/07/2023
Locations: Massachusetts General Hospital, Boston, Massachusetts
Conditions: NASH - Nonalcoholic Steatohepatitis
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Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
NCT04232566
Recruiting
This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.
Gender:
All
Ages:
Between 30 years and 70 years
Trial Updated:
03/23/2023
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona
Conditions: Obesity, Morbid, NASH - Nonalcoholic Steatohepatitis, Chronic Inflammation
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Statins for the Treatment of NASH
NCT04679376
Recruiting
The purpose of this research study is to determine whether the study drug, atorvastatin (Lipitor®), is safe and effective in improving the features of NASH.
Gender:
All
Ages:
Between 18 years and 70 years
Trial Updated:
03/10/2023
Locations: Mayo Clinic Minnesota, Rochester, Minnesota +1 locations
Conditions: NASH - Nonalcoholic Steatohepatitis
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