Bariatric Artery Embolization for Fatty Liver Disease

Not yet recruiting at 1 trial location

Overseen By Keith Pereira, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keith Pereira, MD:

Must not be taking: Anticoagulants, Aspirin, NSAIDs, Hepatotoxic drugs

Disqualifiers: Pregnancy, Substance abuse, Psychiatric problems, Alcohol consumption, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with obesity and a liver condition called NASH (Nonalcoholic Steatohepatitis). Researchers are testing whether a procedure that blocks a specific stomach blood vessel can reduce hunger and lead to weight loss, potentially improving NASH. They use tiny particles called Embospheres Microspheres for this procedure, known as bariatric artery embolization. Individuals with a body mass index (BMI) over 35, who have tried and failed other weight loss methods, and have a confirmed diagnosis of NASH, might be suitable candidates for this study. As an unphased trial, this study presents a unique opportunity to explore innovative treatments that could significantly enhance health.

Will I have to stop taking my current medications?

The trial requires that you stop taking aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) for at least 3 days before and 30 days after the procedure. If you are on anticoagulant medications and radial access cannot be obtained, you may be excluded from the trial. Additionally, if you are taking certain anti-diabetic medications or hepatotoxic drugs, you may not be eligible to participate.

What prior data suggests that this method is safe for treating NASH?

Research has shown that using Embospheres Microspheres to block the left gastric artery (LGAE) has been explored in various studies. One study with dogs demonstrated that this procedure lowered levels of ghrelin, a hormone that stimulates hunger, and resulted in weight loss. This suggests the treatment might aid in weight control, which is crucial for managing obesity and related conditions like Nonalcoholic Steatohepatitis (NASH).

Regarding safety, studies have found the procedure to be generally well-tolerated. Although some adverse health effects were noted, they were uncommon. The treatment has proven feasible and safe in certain cases, but patients should be aware that similar treatments have shown side effects, particularly those affecting the liver.

It is important to remember that while this procedure appears promising, safety details can vary for each individual. Prospective participants should discuss potential risks and benefits with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Embospheres Microspheres for fatty liver disease because this treatment offers a novel approach compared to current options. Most treatments for non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease, focus on lifestyle changes, weight loss, and managing associated conditions like diabetes and high cholesterol. However, Embospheres work by embolizing, or blocking, the left gastric artery to reduce blood flow to the liver, potentially reducing liver fat and inflammation more directly. This method provides a new way to target the disease by altering blood supply, which could offer benefits for patients who struggle with traditional methods of managing NASH.

What evidence suggests that this embolization technique is effective for NASH?

Previous studies have shown that Left Gastric Artery Embolization (LGAE) helps people lose about 10.5% of their body weight within 3-6 months. This procedure blocks certain blood vessels in the stomach, reducing levels of ghrelin, a hormone that induces hunger. While LGAE is mainly studied for weight loss, this trial will specifically use Embospheres Microspheres for left gastric artery embolization to determine if it can also improve Nonalcoholic Steatohepatitis (NASH), a liver condition related to obesity. Although more research is needed to understand its effect on NASH, the weight loss results are promising. ^{1 2 4 5 6}

Who Is on the Research Team?

Kirubahara Vaheesan, MD

Principal Investigator

Assistant professor of radiology- Interventional radiology

Keith Pereira, MD

Principal Investigator

Assistant professor of radiology-Interventional radiology

Brent Neuschwander-Tetri, MD

Principal Investigator

Professor of medicine- gastroenterology

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with obesity (BMI >35 kg/m2) and diagnosed with NASH, who haven't succeeded in losing weight through diet, exercise, or behavior modification. They should have tried other weight loss methods without success and have a liver biopsy confirming NASH within the last year. Participants need to be mentally fit to consent and follow study procedures.

Inclusion Criteria

My liver is working well, with bilirubin levels below 3 mg/dL.

Elevated alanine or aspartate aminotransferase values (ALT >41 or AST>34 U/L)

BMI >35 kg/m2

Exclusion Criteria

My cancer has spread to other parts of my body.

I have had a procedure to block blood flow to certain organs.

Abnormal Nuclear Gastric Motility examination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Left Gastric Artery Embolization (LGAE) to promote weight loss and improve NASH

12 months

Regular follow-up visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weight loss and changes in liver histology

12 months

Regular follow-up visits as per protocol

What Are the Treatments Tested in This Trial?

Interventions

• Embospheres Microspheres

Trial Overview The trial tests if blocking blood vessels leading to the stomach using Embospheres Microspheres can reduce appetite hormone levels, cause significant weight loss, and improve conditions of NASH in obese patients.

How Is the Trial Designed?

Group I: NASH- Left gastric artery embolization Experimental Treatment 1 Intervention

Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Who Is Running the Clinical Trial?

Keith Pereira, MD:

Lead Sponsor

Trials

1

Recruited

8+

Published Research Related to This Trial

Current treatments for nonalcoholic fatty liver disease (NAFLD) are still not very effective, but weight loss remains a key target for therapy despite being difficult to achieve.

Several investigational drugs show promise for treating NASH, but concerns about long-term safety exist, particularly with vitamin E and other medications like pioglitazone and obeticholic acid, which have notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. Issa, D., Wattacheril, J., Sanyal, AJ.[2017]

In a meta-analysis of 41 randomized controlled trials involving 2,944 participants with non-alcoholic steatohepatitis (NASH), 68% of those on placebo experienced at least one adverse event (AE), highlighting the need for careful safety evaluations in this largely asymptomatic condition.

Serious adverse events were reported in 7.8% of placebo participants, with a notably higher incidence in phase 3 trials and those funded by pharmaceutical companies, indicating that the context of the study may influence safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. Tay, PWL., Ng, CH., Lin, SY., et al.[2023]

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02933554

Bariatric Embolization of Arteries for the Treatment ... Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11300538/

Comparative outcomes of trans-arterial radioembolization ... TARE appears to be an equally effective treatment for NASH/NAFLD-induced HCC when compared to other causes of HCC.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1742706122004123

Embolization therapy with microspheres for the treatment of ... Embolization with microspheres is a therapeutic strategy based on the selective occlusion of the blood vessels feeding a tumor.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02933554?term=GLP-1%20NASH&rank=1

Study Details | Bariatric Embolization of Arteries for the ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862037/

Bariatric arterial embolization in patients with body mass ... Limited single-arm studies report BAE as an effective, and relatively safe procedure for promoting weight loss in patients with BMI ranging from 25-40 kg/m 2.

6. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2016160914

Clinical Safety of Bariatric Arterial Embolization Ghrelin suppression and fat loss after left gastric artery embolization in canine model. ... alcoholic fatty liver disease (NAFLD): a case report.