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 trial tests a new ultrasound tool called Velacur to determine if it can quickly and easily detect fatty liver disease (MASLD) in children and teens. The goal is to find a non-invasive method to identify liver issues without complex tests. It targets children and teenagers aged 2 to 20 who may have liver problems or are visiting a liver clinic for evaluation. As an unphased trial, participants contribute to groundbreaking research that may lead to simpler, more accessible liver diagnostics for young patients.

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 prior data suggests that Velacur ultrasound is safe for detecting hepatic steatosis in children and adolescents?

Research shows that Velacur is a safe and easy-to-use method for checking liver health. In various studies, Velacur has identified liver issues like fatty liver disease without harming patients. It uses ultrasound technology, which is non-invasive and radiation-free. One study even described it as a minimal risk procedure, indicating its high safety level. This makes Velacur an excellent choice for those concerned about the safety of diagnostic tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Velacur because it offers a new, non-invasive approach to assessing fatty liver disease, specifically MASLD, in young patients. Unlike traditional methods that might rely on more invasive procedures like liver biopsies, Velacur uses ultrasound technology to evaluate liver health. This method is not only less invasive but also potentially quicker and easier, making it particularly appealing for children and young adults who require liver evaluation. This innovation could lead to early and more accessible diagnosis, making treatment and management more effective.

What evidence suggests that Velacur ultrasound is effective for detecting fatty liver disease?

Research has shown that Velacur, used in this trial's Velacur Ultrasound arm, accurately checks liver conditions such as fatty liver disease. One study found Velacur to be 95% accurate in identifying liver fat. Another study showed it outperformed FibroScan in measuring liver fat. Velacur also distinguished between healthy individuals and those with moderate or advanced liver stiffness. These findings suggest Velacur could reliably detect liver problems in young patients. ^{1 6 7 8 9}

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+

The Obesity Society

Collaborator

Trials

8

Recruited

340+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898527/

Accuracy of Velacur in Assessing MASLD and MASH ... This study validates the use of Velacur as a non-invasive tool for assessment of steatosis and fibrosis, hallmarks of MASLD and MASH.

2. sonicincytes.com sonicincytes.com/sonic-incytes-announces-clinical-trial-data-comparing-velacur-and-fibroscan/

Sonic Incytes Announces Clinical Trial Data Comparing ... Velacur was found to be more effective than FibroScan at measuring liver fat (steatosis), and achieved statistical significance over FibroScan in patients with ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/8877130

The Use of Noninvasive Velacur® for Discriminating ... Velacur® was successfully able to differentiate healthy volunteers from patients with moderate or advanced liver stiffness according to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38517204/

Velacur ACE outperforms FibroScan CAP for diagnosis of ... Conclusions: Velacur was superior to FibroScan for liver fat detection with MRI-PDFF as the reference. Velacur and FibroScan were not ...

5. synapse.patsnap.com synapse.patsnap.com/article/fda-clears-sonic-incytes-velacurC2AE-vdff-for-masld-and-mash

FDA Clears Sonic Incytes' Velacur® VDFF for MASLD and ... VDFF boasts an impressive accuracy of 95% in classifying patients with more than 5% MRI-PDFF, effectively diagnosing hepatic steatosis. VDFF's ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233977.pdf

Sonic Incytes Rhona Shanker President Z & B Enterprises, Inc ... The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949668324000296

Methods and validation of velacur determined fat fraction in ... The Velacur Determined Fat Fraction (VDFF) is an accurate and accessible way to estimate steatosis as measured by MRI-PDFF.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962894/

Velacur ACE outperforms FibroScan CAP for diagnosis of ... Velacur was superior to FibroScan for liver fat detection with MRI-PDFF as the reference. Velacur and FibroScan were not statistically different for liver ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/23/NCT04576923/Prot_006.pdf

Quantitative Ultrasound with Velacur for Evaluation of Non- ... Quantitative Ultrasound with Velacur for Evaluation of Non-Alcoholic Fatty Liver Disease ... Given this is a minimal risk study, no Data Safety ...