Velacur for Fatty Liver Disease

Recruiting at 1 trial location

Overseen By Miriam Vos, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Ascites, Pregnancy, Implanted devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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). ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Who Is on the Research Team?

Miriam Vos, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I have fluid buildup in my abdomen.

Have an implanted electronic device such as pacemaker, neurostimulator, or cochlear implant

Pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Velacur Ultrasound Experimental Treatment 4 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Robuvit® on the progression of non-alcoholic fatty liver disease. Belcaro, G., Cox, DM., Cesarone, MR., et al.[2022]

Citations

1. Greece pubmed.ncbi.nlm.nih.gov

Prognosis of patients with a diagnosis of fatty liver--a registry-based cohort study. [2004]

2. Spain pubmed.ncbi.nlm.nih.gov

[Medical management of primary nonalcoholic fatty liver disease]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with NAFLD and elevated liver enzymes. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Which treatment for nonalcoholic fatty liver disease? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Pemafibrate Dramatically Ameliorated the Values of Liver Function Tests and Fibrosis Marker in Patients with Non-Alcoholic Fatty Liver Disease. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Liver and gallbladder disease before and after very-low-calorie diets. [2018]

9. Poland pubmed.ncbi.nlm.nih.gov

Pemafibrate therapy for non-alcoholic fatty liver disease is more effective in lean patients than obese patients. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Effects of Robuvit® on the progression of non-alcoholic fatty liver disease. [2022]