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A study to evaluate safety and explore efficacy of new lipase NHS7108 compared with pancrelipase in adult participants with exocrine pancreatic insufficiency
EU CTIS ID: 2025-521816-20-00
What this study is testing
Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI). Coefficient of nitrogen absorption (CNA) will be measured as part of safety
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
- 2. 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. *Fecal Elastase < 200 µg/g due to, but not limited to, the following causes: total or partial pancreatectomy, CP supported by diagnostic imaging, or CF. If not available at time of screening, a baseline fecal elastase assessment will be performed for the purpose of this study.
- 3. CFA off PERT of <80% at screening.
- please refer to the protocol for the full list of inclusion criteria
- 4. 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)
You likely can't join if
- 10. Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
- please refer to the protocol for the full list of exclusion criteria
- 13. Participant has any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis at screening as judged by the Investigator OR as detailed below: • 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.
- 2. 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 intussusception. Hernia repair, appendectomy, cesarean section, tubal ligation, hysterectomy, polypectomy, hemorrhoidectomy, or cholecystectomy are allowed if performed at least 2 years before randomization and have no impact on intestinal transit or absorption.
- 3. Participants on enteral feeding.
- 4. Participants with celiac disease.
See the full eligibility criteria
Who can join
- 1. Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
- 2. 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. *Fecal Elastase < 200 µg/g due to, but not limited to, the following causes: total or partial pancreatectomy, CP supported by diagnostic imaging, or CF. If not available at time of screening, a baseline fecal elastase assessment will be performed for the purpose of this study.
- 3. CFA off PERT of <80% at screening.
- please refer to the protocol for the full list of inclusion criteria
- 4. 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)
What rules you out
- 10. Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
- please refer to the protocol for the full list of exclusion criteria
- 13. Participant has any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis at screening as judged by the Investigator OR as detailed below: • 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.
- 2. 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 intussusception. Hernia repair, appendectomy, cesarean section, tubal ligation, hysterectomy, polypectomy, hemorrhoidectomy, or cholecystectomy are allowed if performed at least 2 years before randomization and have no impact on intestinal transit or absorption.
- 3. Participants on enteral feeding.
- 4. Participants with celiac disease.
- 5. 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.
- 7. Concurrent conditions having a clinically significant impact on GI motility function, with the exception of pancreatic insufficiency due to pancreatectomy or CP.
- 8. Any significant clinical/laboratory/radiological sign of unstable or unexpectedly deteriorating respiratory disease during the study duration, at the discretion of the Investigator.
- 9. 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.