RELiZORB for Pancreatic Insufficiency

Overseen By Casey M Luckhurst, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Disqualifiers: Chronic pancreatitis, GI cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 14 days

60 Participants Needed

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 exocrine pancreatic insufficiency (EPI) following pancreatitis, a condition where the pancreas fails to produce enough enzymes for proper digestion. The treatment, RELiZORB, may help those relying on feeding tubes obtain the necessary enzymes. The trial will compare patients using RELiZORB with those not using it to evaluate its effectiveness. Individuals who have experienced pancreatitis and require a feeding tube for most of their nutrition might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RELiZORB is likely to be safe for humans?

Research has shown that RELiZORB is safe and well-tolerated. Previous studies found that when used correctly, RELiZORB does not cause major side effects. Instead, it improves digestion by increasing fatty acid levels in the blood, which are crucial for energy and cell function. As a result, people using RELiZORB typically experience fewer digestive problems.

RELiZORB has been studied in individuals with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis, but not in those with EPI from pancreatitis. However, its safety in other conditions suggests it might be safe for this new group as well. It is important to follow a doctor's advice when using RELiZORB, especially since it is designed for use with feeding tubes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic insufficiency?

RELiZORB is unique because it provides a novel way to help people with pancreatic insufficiency digest fats more effectively. Unlike traditional pancreatic enzyme replacement therapies (PERTs), which require patients to ingest pills or capsules with meals, RELiZORB is an enzyme cartridge that attaches to feeding tubes, breaking down fats before they enter the body. This method ensures that the fats are pre-digested, making absorption easier and potentially improving nutritional outcomes for patients. Researchers are excited about RELiZORB because it simplifies the delivery of necessary enzymes, potentially leading to better management of pancreatic insufficiency symptoms.

What evidence suggests that RELiZORB might be an effective treatment for pancreatic insufficiency?

Research has shown that RELiZORB benefits people with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis. In these patients, RELiZORB aids in breaking down fats by facilitating the delivery of important enzymes. Studies have found that RELiZORB reduces the need for intravenous nutrition and increases nutrition delivered through a feeding tube. However, its effectiveness for EPI caused by pancreatitis remains unstudied. In this trial, some participants will receive tube feeds with RELiZORB, while others will receive tube feeds without it. The potential benefit for pancreatitis patients is that RELiZORB might simplify their feeding process by delivering enzymes more efficiently. ^{2 6 7 8 9}

Who Is on the Research Team?

Casey M Luckhurst, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for hospitalized patients who need more than half of their daily nutrition through a feeding tube and have moderate to severe exocrine pancreatic insufficiency (EPI) due to pancreatitis. Participants must be able to consent and have a PEI-Q score of 1.4 or higher, indicating EPI.

Inclusion Criteria

I am currently in the hospital.

I am willing and able to agree to participate in the study.

I have been diagnosed with severe EPI, scoring 1.4 or higher on the PEI-Q.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tube feeds with or without RELiZORB to manage exocrine pancreatic insufficiency

14 days

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biochemical profile and stool assessment

90 days

Visits at 30, 60, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• RELiZORB

Trial Overview The study tests RELiZORB's effectiveness in managing EPI for tube-fed patients with pancreatitis. Previously studied only in cystic fibrosis cases, this trial seeks to determine if RELiZORB can simplify enzyme delivery for these individuals.

How Is the Trial Designed?

Group I: RELiZORB Experimental Treatment 1 Intervention

Patients will receive tube feeds (via nasogastric or nasojejunal tube) with the use of RELiZORB

Group II: No RELiZORB Active Control 1 Intervention

Patients will receive tube feeds (via nasogastric or nasojejunal tube) without the use of RELiZORB

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Alcresta Therapeutics, Inc.

Industry Sponsor

Trials

6

Recruited

240+

Published Research Related to This Trial

Pancreatic enzyme replacement therapy is crucial for patients with exocrine pancreatic insufficiency, particularly those who have undergone surgery, have chronic pancreatitis, or cystic fibrosis, with lipase being essential to reduce fat malabsorption (steatorrhoea).

Different formulations of pancreatic enzymes, including porcine pancreatin and enteric-coated preparations, have varying effectiveness and must be tailored to individual patient needs, highlighting the importance of understanding both the patient's condition and the specific characteristics of the enzyme supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and pharmacological aspects of pancreatic enzyme substitution therapy]. Löser, C., Fölsch, UR.[2006]

RELiZORB is a novel in-line digestive cartridge that effectively addresses the need for pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) receiving enteral nutrition, demonstrating compatibility with various formulas.

In clinical evaluations, RELiZORB was able to hydrolyze over 90% of fats in enteral nutrition formulas into absorbable fatty acids and monoglycerides, significantly improving fat absorption for patients who struggle with traditional long-chain triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options for addressing exocrine pancreatic insufficiency in patients receiving enteral nutrition supplementation. Freedman, SD.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06691893?term=AREA%5BBasicSearch%5D(lipase)&rank=9

Evaluating the Efficacy of RELiZORB in Managing Exocrine ... This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/589795

Evaluating the Efficacy of RELiZORB in Managing Exocrine ... This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11510683/

Optimization of Exocrine Pancreatic Insufficiency in Pancreatic ... This study provides data to support clinical decision making and guidance for pancreatectomy patients with EPI symptoms. We also provide a framework for ...

4. trialx.com trialx.com/clinical-trials/listings/296547/evaluating-the-efficacy-of-relizorb-in-managing-exocrine-pancreatic-insufficiency-in-tube-fed-pancreatitis-patients/

Evaluating the Efficacy of RELiZORB in Managing Exocrine ... This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation ...

5. alcresta.com alcresta.com/clinical/

Clinical Studies In conclusion, RELiZORB showed a reduction in PN dependence, increased EN advancement, and an increase in intestinal length, an indicator of intestinal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6155360/

Absorption and Safety With Sustained Use of RELiZORB ... RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN150001.pdf

De Novo Summary (DEN150001) Page 1 of 15 RELIZORB ... The use of RELIZORB™ has not been studied in patients with exocrine pancreatic insufficiency. RELIZORB™ has not been evaluated in pediatric populations. PLEASE ...

8. relizorb.com relizorb.com/pdf/RELiZORB-Instructions-for-Use.pdf

RELiZORB Instructions for Use RELiZORB is indicated for use with enteral feeding only; patients should follow physician's guidance for pancreatic enzyme replacement therapy (PERT) use for ...

9. molinahealthcare.com molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/ne/Pharmacy/Relizorb-immobilized-lipase-cartridge-MNR-C17943-A.pdf

Relizorb (immobilized lipase cartridge) MNR C17943-A The safety and efficacy of RELiZORB was assessed in a multicenter, prospective, randomized, double-blind, placebo controlled, cross-over study, ...