Exocrine Pancreatic Insufficiency study: NHS7108 vs Zenpep®
Official title A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
ClinicalTrials.gov ID: NCT07559175
What this study is testing
What is NHS7108?
NHS7108 is an investigational capsule being studied as a potential treatment for Exocrine Pancreatic Insufficiency (EPI). It is designed to help break down fats in the digestive system using a specific enzyme.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a new enzyme called NHS7108 is safe and helps the body absorb fat and protein as well as the standard treatment, Zenpep.
- Who it's for
- Adults who have exocrine pancreatic insufficiency, a condition where the pancreas does not make enough enzymes to digest food.
- What's involved
- Participants take capsules with every meal and snack for two 14-day periods. They stay in a supervised setting for about 7 days at the start and end of each period to collect stool samples and have blood tests.
- Time commitment
- The study lasts about 14 weeks, including a screening phase and two treatment phases with specific supervised stays.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
- Participants with clinically confirmed\ chronic established (not due to a transient clinical diagnosis, i.e., acute pancreatitis) EPI and with a...
- CFA off PERT of \<80% at screening
- Normal body mass index (BMI) by age and sex to ensure participant's EPI is adequately controlled in the opinion of the investigator (BMI of at least...
- Standard-of-care medications are allowed (antibiotics, mucolytic agents, aerosols, antacids), if on stable doses for at least 1 month prior to...
You likely can't join if
- Female participants who are breastfeeding at the time of screening.
- Previous GI surgery, except for non-invasive neonatal or early childhood procedures such as correction of hypertrophic pyloric stenosis, surgical...
- Participants on enteral feeding.
- Participants with celiac disease.
- Known allergy or adverse reaction history to any component of NHS7108, Zenpep®, omega-3 oil, and/or to any other product administered during the...
- Concurrent clinically significant, at the discretion of the Investigator, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic...
See the full eligibility criteria
- Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
- Participants with clinically confirmed\ chronic established (not due to a transient clinical diagnosis, i.e., acute pancreatitis) EPI and with a clinical indication for PERT.
- CFA off PERT of \<80% at screening
- Normal body mass index (BMI) by age and sex to ensure participant's EPI is adequately controlled in the opinion of the investigator (BMI of at least 17.0 and no greater than 35.0 kg/m²)
- Standard-of-care medications are allowed (antibiotics, mucolytic agents, aerosols, antacids), if on stable doses for at least 1 month prior to baseline CFA and CNA assessments and must not be altered in dose or stopped...
- Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators are allowed if on stable doses for at least 3 months prior to randomization.
- Non-sterilized male participants are eligible to participate if they agree to one of the following starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up...
- Female participants of childbearing potential (as defined in Appendix 4) are eligible to participate if they meet the following criteria: Agree not to become pregnant during the clinical study period and until the...
- Female participants of nonchildbearing potential are eligible to participate if one of the following conditions apply: Must have a confirmed clinical history of sterility (documented hysterectomy, bilateral...
- Female participants must agree not to donate ova starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up.
- For WOCBP only, serum pregnancy test will be performed at screening and urine pregnancy tests will be performed at the timepoints outlined in the SoA.
- The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participants agree not to participate in another treatment study while participating in the study.
- Female participants who are breastfeeding at the time of screening.
- Previous GI surgery, except for non-invasive neonatal or early childhood procedures such as correction of hypertrophic pyloric stenosis, surgical correction of Meckel's diverticulum, volvulus, or intestinal...
- Participants on enteral feeding.
- Participants with celiac disease.
- Known allergy or adverse reaction history to any component of NHS7108, Zenpep®, omega-3 oil, and/or to any other product administered during the study, including the blue dye.
- Concurrent clinically significant, at the discretion of the Investigator, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but...
- Concurrent conditions having a clinically significant impact on GI motility function, with the exception of pancreatic insufficiency due to pancreatectomy or CP.
- Any significant clinical/laboratory/radiological sign of unstable or unexpectedly deteriorating respiratory disease during the study duration, at the discretion of the Investigator.
- Omega-3 supplements are prohibited during all the study periods and should be stopped at least 7 days prior to the baseline off-treatment fat absorption assessments.
- Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
- Acute use of oral or intravenous antibiotics within 2 weeks prior to the first dose of study intervention.
- Treatment with any investigational drug or device/treatment within the 30 days or 5 half-lives of the drug (whichever is longer) prior to first dose of study intervention.
- Estimated glomerular filtration rate \< 60 mL/min at screening visit.
- Total bilirubin \> 1.5 × upper limit of normal (ULN) at screening visit.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × ULN at screening visit.
- Positive human immunodeficiency virus (HIV) antibody test.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to first dose of study intervention AND positive on reflex to hepatitis C RNA test.
- Concurrent drug or alcohol addiction that in the opinion of the Investigator would preclude participation and compliance with the study procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- Lenexa, Kansas, United States
- Hershey, Pennsylvania, United States
- Budapest, Hungary
- Csongrád, Hungary
- Lleida, Spain
- Málaga, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Lenexa, Kansas, United States; Hershey, Pennsylvania, United States; Budapest, Hungary; Csongrád, Hungary; Lleida, Spain; Málaga, Spain and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.