200 Participants Needed

Velacur for Fatty Liver Disease

Recruiting at 1 trial location
MV
Overseen ByMiriam Vos, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Velacur for treating fatty liver disease?

There is no direct evidence supporting the effectiveness of Velacur for fatty liver disease, but similar treatments like thiazolidinediones and antioxidants have shown some improvement in liver conditions in clinical trials.12345

How does the drug Velacur differ from other treatments for fatty liver disease?

There is no specific information available about Velacur, but other treatments like pemafibrate are unique because they target specific receptors in the liver to improve liver function and reduce fibrosis (scarring).678910

What is the purpose of this trial?

This study aims to test the utility of Velacur ultrasound as a non-invasive, rapid, point of care diagnostic tool for detecting the presence and amount of hepatic steatosis in children and adolescents aged 2 - 20 years.

Research Team

MV

Miriam Vos, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for children and adolescents aged 2-20 years who may have a condition called MASLD, which involves fat buildup in the liver. The study will include those likely to have this condition and excludes anyone for whom the tests are not safe or suitable.

Inclusion Criteria

I can have an MRI without needing to be sedated.
My child has given their agreement to participate.
Written/verbal informed consent from parent or legal guardian
See 1 more

Exclusion Criteria

I have fluid buildup in my abdomen.
Have an implanted electronic device such as pacemaker, neurostimulator, or cochlear implant
Pregnancy
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo Velacur ultrasound and/or blood biomarker collection to assess hepatic steatosis and fibrosis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the diagnostic tests

4 weeks

Treatment Details

Interventions

  • Velacur
Trial Overview The trial is testing Velacur ultrasound against standard procedures like liver biopsy, MRI, and blood tests to see if it can effectively diagnose fatty liver disease without being invasive.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Velacur UltrasoundExperimental Treatment4 Interventions
Patients 2 to 20 years of age with suspicion of MASLD or presenting to liver clinic for evaluation of liver disease, including possible MASLD receiving a Velacur ultrasound.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Sonic Incytes

Industry Sponsor

Trials
6
Recruited
710+

Findings from Research

Lifestyle changes, such as weight loss and increased physical activity, are the primary recommended strategies for managing nonalcoholic fatty liver disease (NAFLD), as they are essential for preventing progressive liver failure.
While some pharmacological treatments have shown improvements in liver biochemistry, only a few have demonstrated benefits in liver histology, and these effects do not last after treatment ends, indicating that more research is needed before these drugs can be recommended outside of clinical trials.
Which treatment for nonalcoholic fatty liver disease?Moscatiello, S., Marzocchi, R., Villanova, N., et al.[2019]
In a systematic review of 10 studies involving patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), treatment with 4 mg saroglitazar significantly reduced liver enzymes, including alanine transaminase (ALT) and aspartate transaminase (AST), indicating improved liver function.
Saroglitazar also led to significant improvements in liver stiffness and metabolic parameters such as glycated hemoglobin, total cholesterol, and triglycerides, suggesting it is an effective and safe treatment option for managing NAFLD and NASH.
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis.Bandyopadhyay, S., Samajdar, SS., Das, S.[2023]
Robuvit® supplementation for 3 months in patients with non-alcoholic fatty liver disease (NAFLD) significantly improved liver function markers, including decreased levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), indicating better hepatic metabolism.
The study, involving 34 subjects, showed that Robuvit® was well-tolerated with no side effects, and it also led to a significant reduction in liver size and echogenicity, suggesting a prevention of progression to liver fibrosis.
Effects of Robuvit® on the progression of non-alcoholic fatty liver disease.Belcaro, G., Cox, DM., Cesarone, MR., et al.[2022]

References

Prognosis of patients with a diagnosis of fatty liver--a registry-based cohort study. [2004]
[Medical management of primary nonalcoholic fatty liver disease]. [2019]
Long-term follow-up of patients with NAFLD and elevated liver enzymes. [2023]
Which treatment for nonalcoholic fatty liver disease? [2019]
A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. [2022]
Pemafibrate Dramatically Ameliorated the Values of Liver Function Tests and Fibrosis Marker in Patients with Non-Alcoholic Fatty Liver Disease. [2022]
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]
Liver and gallbladder disease before and after very-low-calorie diets. [2018]
Pemafibrate therapy for non-alcoholic fatty liver disease is more effective in lean patients than obese patients. [2023]
Effects of Robuvit® on the progression of non-alcoholic fatty liver disease. [2022]
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