In short
Clinical trials are investigating LIPASE, including a new lipase product compared with pancrelipase. These studies look at safety and early signs of benefit in adults with exocrine pancreatic insufficiency. The main goal is to see how well the treatment is tolerated and whether it helps digestion-related measures.
Key points
- LIPASE clinical trials in the provided data focus on adults with exocrine pancreatic insufficiency. The main study is a Phase 2 trial of a new lipase product, NHS7108, compared with pancrelipase. Researchers are mainly checking safety, including adverse events and changes in lab tests, vital signs, ECG, and physical examination findings. The trial also looks at early efficacy using the coefficient of nitrogen absorption. The study is interventional and includes 44 participants.
Trial overview
The available study is an interventional study, which means participants receive a study treatment so researchers can observe the results. It is testing a new lipase product called NHS7108 and comparing it with pancrelipase in adults with exocrine pancreatic insufficiency. The study status is Authorised, and the planned enrollment is 44 participants.
Who can join
The trial is for adult participants with exocrine pancreatic insufficiency, also called EPI. EPI is the condition the study is focused on, so the trial is not described as being for children or for other diseases.
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. 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.
Another outcome is the change in coefficient of nitrogen absorption (CNA) after 14 days of NHS7108 treatment. CNA is a measure linked to how well the body absorbs nitrogen from food, which helps researchers judge digestion-related benefit in this study.
Trial design and phase
This is a Phase 2 trial. Phase 2 studies usually look carefully at safety and also explore whether a treatment may start to show benefit. 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.
Key points for patients
- The study is focused on people with EPI, a condition where the pancreas does not make enough digestive enzymes.
- The main question is whether NHS7108 is safe and whether it may help digestion-related outcomes over a short 14-day period.
- Researchers are watching for adverse events and also checking standard safety tests such as blood tests, heart tracing, and physical exam findings.
- 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.
- Because the enrollment is 44 participants, this is a relatively small study designed for early research rather than a large final proof of benefit.