Table of contents
Trial overview
The available study is an interventional study, which means participants receive a study treatment so researchers can observe the results.[1] It is testing a new lipase product called NHS7108 and comparing it with pancrelipase in adults with exocrine pancreatic insufficiency.[1] The study status is Authorised, and the planned enrollment is 44 participants.[1]
Who can join
The trial is for adult participants with exocrine pancreatic insufficiency, also called EPI.[1] EPI is the condition the study is focused on, so the trial is not described as being for children or for other diseases.[1]
What is being measured
The main safety measure is the number of participants who report one or more adverse events, which means unwanted medical problems during the study.[1] The study also checks changes from baseline, which means changes compared with the starting point, in safety tests such as clinical laboratory tests, vital signs, 12-lead ECG, and physical examination after 14 days of NHS7108 treatment.[1]
Another outcome is the change in coefficient of nitrogen absorption (CNA) after 14 days of NHS7108 treatment.[1] CNA is a measure linked to how well the body absorbs nitrogen from food, which helps researchers judge digestion-related benefit in this study.[1]
Trial design and phase
This is a Phase 2 trial.[1] Phase 2 studies usually look carefully at safety and also explore whether a treatment may start to show benefit.[1] In this study, NHS7108 is given daily for 14 days, and the trial compares it with Zenpep delayed-release capsule, which is listed as pancrelipase in the source data.[1]
Key points for patients
The study is focused on people with EPI, a condition where the pancreas does not make enough digestive enzymes.[1]
The main question is whether NHS7108 is safe and whether it may help digestion-related outcomes over a short 14-day period.[1]
Researchers are watching for adverse events and also checking standard safety tests such as blood tests, heart tracing, and physical exam findings.[1]
The study includes a comparison with pancrelipase, so researchers can see how the new product performs against an existing treatment listed in the trial data.[1]
Because the enrollment is 44 participants, this is a relatively small study designed for early research rather than a large final proof of benefit.[1]
