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TRIACYLGLYCEROL LIPASE

Clinical trials of TRIACYLGLYCEROL LIPASE are studying a new lipase treatment in adults with exocrine pancreatic insufficiency. These trials mainly look at safety and early signs of benefit compared with pancrelipase. The goal is to see how well it works in people who need help digesting food.

Table of contents

Trial overview

The available trial for TRIACYLGLYCEROL LIPASE is a Phase 2 interventional study in adults with exocrine pancreatic insufficiency (EPI).[1] It is authorised and plans to enroll 44 participants.[1]

The study title says it will evaluate safety and explore efficacy of a new lipase called NHS7108 compared with pancrelipase.[1] “Efficacy” means how well a treatment works.[1]

Who is being studied

This trial is for adult participants with exocrine pancreatic insufficiency.[1] EPI is the condition being studied, and the trial data do not give more detailed eligibility rules.[1]

People in this study are being followed because they need support with digestion and nutrient absorption.[1] The study is not described as a pediatric trial, so the listed population is adults only.[1]

What is being tested

The study compares NHS7108 capsules with Zenpep delayed-release capsules, which are listed as pancrelipase in the trial record.[1] Both are given by mouth.[1]

The brief summary says different doses of NHS7108 are given daily for 14 days in participants with EPI.[1] This means the researchers are looking at short-term treatment effects over two weeks.[1]

Study phase and design

This is an interventional trial, which means participants receive a study treatment and researchers observe the effects.[1] It is a Phase 2 study, so the main focus is safety with early signs of benefit.[1]

Phase 2 studies often help researchers decide whether a treatment should be studied further in larger groups.[1] In this trial, the study is also meant to compare the new treatment with an existing one used for the same condition.[1]

What outcomes are measured

The main safety outcome is the number of participants who report one or more adverse events.[1] An adverse event is any unwanted health problem that happens during the study.[1]

Researchers also track changes from baseline in safety parameters after 14 days of NHS7108 treatment.[1] These safety checks include clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examination.[1]

Another key measure is the change from baseline in coefficient of nitrogen absorption (CNA) after 14 days.[1] CNA is used here as a way to assess how well the body absorbs nitrogen, which helps show protein absorption.[1]

How to read the study results

Because this is a small Phase 2 study, the results will mainly help show whether the treatment is safe enough and whether it may be worth studying more.[1] The study does not yet provide final proof that the treatment works better than the comparison treatment.[1]

For patients, the most important points are the condition studied, the adult population, the short 14-day treatment period, and the safety-focused outcomes.[1] These details show that the trial is an early step in learning more about TRIACYLGLYCEROL LIPASE-related treatment research.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521816-20-00 Phase 2 Exocrine Pancreatic Insufficiency Authorised 44

FAQ

  • What is being studied in TRIACYLGLYCEROL LIPASE trials? The trial is testing a new lipase treatment called NHS7108 and comparing it with pancrelipase. It is designed to see if the study treatment is safe and whether it may help adults with exocrine pancreatic insufficiency.
  • Who can take part in these trials? The study is for adult participants with exocrine pancreatic insufficiency. The trial data do not list more detailed entry rules.
  • What phase is the TRIACYLGLYCEROL LIPASE trial? This is a Phase 2 trial. Phase 2 studies usually look at both safety and early signs that a treatment may work.
  • What condition is being studied? The condition is exocrine pancreatic insufficiency, often shortened to EPI. This means the pancreas does not make enough digestive enzymes to help break down food well.
  • What results are being measured? The trial measures adverse events, safety checks such as blood tests, vital signs, ECG, and physical exam findings. It also measures change in the coefficient of nitrogen absorption, which is a way to see how well the body absorbs protein.

Ongoing Clinical Trials on TRIACYLGLYCEROL LIPASE

  • NHS7108 for Exocrine Pancreatic Insufficiency in Adult Patients

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Bulgaria Hungary Italy Poland Spain

Glossary

  • Exocrine pancreatic insufficiency (EPI): A condition where the pancreas does not make enough digestive enzymes, so the body has trouble breaking down food and absorbing nutrients.
  • Lipase: A digestive enzyme used in the study name and treatment comparison. In this trial context, it refers to the study treatment being evaluated.
  • Pancrelipase: A comparison treatment used in the trial. It is given as Zenpep delayed-release capsules in the study.
  • Interventional study: A type of clinical trial where participants receive a treatment so researchers can study its effects.
  • Phase 2: A mid-stage trial phase that looks at safety and early evidence of benefit in a group of participants.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Safety parameters: Checks used to monitor participant safety, such as lab tests, blood pressure, heart tracing, and physical examination.
  • Vital signs: Basic body measurements such as heart rate, blood pressure, and temperature.
  • Electrocardiogram (ECG): A test that records the electrical activity of the heart.
  • Coefficient of nitrogen absorption (CNA): A measure used to see how well the body absorbs nitrogen from food, which helps show protein absorption.