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NHS7108 for Exocrine Pancreatic Insufficiency in Adult Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Exocrine Pancreatic Insufficiency, a condition in which the pancreas does not make enough digestive enzymes to break down food properly. The treatment being studied is NHS7108, an oral lipase capsule taken at different doses. Lipase is a substance that helps the body digest fat. The study also uses Zenpep, a delayed-release capsule that contains digestive enzymes and is used as the comparison treatment. The purpose of the study is to assess safety and to explore how well NHS7108 works in adults with this condition.

The study is carried out over short treatment periods. Participants receive NHS7108 or Zenpep by mouth, and the treatments are compared in a crossover design, which means the same person may receive more than one study treatment at different times. During the study, health checks are done to look for side effects and changes in routine medical tests, heart tracing, and physical examination findings. The study also looks at how well food is digested and at changes in stomach and bowel symptoms, including stool frequency and stool consistency.

The main focus is on different doses of NHS7108 taken daily for 14 days. The study compares these doses with Zenpep and follows changes in digestion-related measures such as nitrogen absorption, which shows how well protein from food is being taken up by the body, and fat absorption. It also checks levels of certain fats in the blood after a meal and records digestive symptoms over time.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the study period
When you join the study, you enter a randomized, open-label, active-controlled, crossover trial. Randomized means the study treatment is assigned by chance. Open-label means you know which treatment you are taking. Active-controlled means the study compares two active medicines. Crossover means you receive more than one study treatment during the trial.
The study is for adults with exocrine pancreatic insufficiency (EPI), which means the pancreas does not make enough digestive enzymes to help break down food.
The study medicine is NHS7108 capsules, taken by mouth. The comparison medicine is Zenpep delayed-release capsule, taken by mouth. Zenpep contains the digestive enzymes amylase, lipase, and protease.
Step 2
First 14-day treatment period
You take NHS7108 capsules by mouth daily for 14 days.
The dose of NHS7108 is 240 mg each time it is taken.
During this period, the study checks for adverse events (medical problems or unwanted effects that happen during the study).
Your safety is assessed by laboratory tests, vital signs such as blood pressure and pulse, a 12-lead ECG (a test that records the heart’s electrical activity), and a physical examination after the 14-day treatment.
The study also measures coefficient of nitrogen absorption (CNA), which shows how much nitrogen from food is absorbed by your body.
Step 3
Assessment after the first 14-day treatment
After the first 14-day treatment, the study measures changes from your starting point in safety results, including laboratory tests, vital signs, ECG, and physical examination.
The study measures the change in CNA after the 14-day NHS7108 treatment.
The study also measures coefficient of fat absorption (CFA), which shows how much fat from food is absorbed.
The study checks GI symptoms (gastrointestinal symptoms, meaning stomach and bowel symptoms) using the eDiary (an electronic diary you complete).
The study records stool frequency in the eDiary.
The study records stool consistency using the Bristol Stool Scale, which is a chart that describes how hard or soft stool is.
Step 4
Comparison treatment period with zenpep
At a later point in the crossover study, you take Zenpep delayed-release capsules by mouth.
The dose of Zenpep is 600,000 units each time it is taken.
Zenpep is taken as the comparison treatment for the study’s effectiveness checks.
The study compares results after NHS7108 with results after Zenpep.
Step 5
Assessment after the zenpep comparison period
After the Zenpep treatment period, the study compares your results with those from the NHS7108 period.
The study looks at CFA after 14 days of NHS7108 compared with Zenpep.
The study measures an omega-3 absorption test, which checks how much of two omega-3 fats, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear in your blood over a 24-hour period after a standard breakfast following 14 days of NHS7108 treatment.
The study continues to record GI symptoms, stool frequency, and stool consistency in the eDiary.
Step 6
End of the trial
The trial ends after the study has collected the safety and absorption results from the treatment periods.
The planned study period runs from 29 may 2026 to 19 april 2027.

Who can join the trial?

7 criteria

Be a male or female adult aged 18 to 85 years at the time of signing the consent form.
Have chronic, established exocrine pancreatic insufficiency (EPI), meaning the condition is confirmed and not only a short-term problem such as acute pancreatitis (a sudden inflammation of the pancreas).
Have a medical need for PERT, which means pancreatic enzyme replacement therapy used to help digest food.
Have a fecal elastase level of less than 200 µg/g, or have this test done at screening if it is not already available. Fecal elastase is a stool test that helps measure how well the pancreas is working.
Have EPI caused by one of the allowed conditions, such as removal of all or part of the pancreas, chronic pancreatitis confirmed by imaging tests, or cystic fibrosis.
Have CFA off PERT of less than 80% at screening. CFA means coefficient of fat absorption, a measure of how well the body absorbs fat without enzyme treatment.
Have a body mass index (BMI) between 17.0 and 35.0 kg/m², with the investigator judging that the EPI is adequately controlled. BMI is a measure of body weight compared with height.

Who cannot join the trial?

12 criteria

Starting a new medication or changing the dose of an existing medication within 1 month before the first study tests.
Any important abnormal result in blood tests, clotting tests, blood chemistry, or urine tests at screening, if the study doctor thinks it matters.
A kidney test showing estimated glomerular filtration rate (a measure of how well the kidneys filter blood) of less than 60 mL/min.
Bilirubin (a substance measured in blood that can rise with liver or bile duct problems) higher than 1.5 times the normal upper limit.
ALT or AST (liver enzymes, which are proteins that can rise when the liver is irritated or damaged) higher than 2 times the normal upper limit.
Any previous gastrointestinal surgery (surgery on the stomach or intestines), except some early-life procedures or certain surgeries that were done at least 2 years before randomization and do not affect digestion or absorption.
Using enteral feeding (nutrition given through a tube into the stomach or intestine).
Having celiac disease.
A known allergy or bad reaction to any part of NHS7108, Zenpep, omega-3 oil, any other study product, or the blue dye used in the study.
Any other condition that significantly affects GI motility (how food moves through the stomach and intestines), except pancreatic insufficiency caused by pancreatectomy (surgical removal of the pancreas) or CP (chronic pancreatitis, a long-term inflammation of the pancreas).
Any important sign that a respiratory disease is unstable or getting worse during the study, based on the study doctor’s judgment.
Use of omega-3 supplements during the study, or not stopping them at least 7 days before the baseline fat absorption tests.

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Verified sites

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Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

NHS7108 capsules
are the study treatment being tested in this trial. They are taken by mouth and are meant to help replace the lipase enzyme that the body needs to break down fats from food. The trial is looking at whether NHS7108 is safe and whether it may help people with exocrine pancreatic insufficiency digest food better.
Zenpep delayed-release capsule
is the active comparison treatment in the study. It is also taken by mouth and contains digestive enzymes, including lipase, amylase, and protease. It is used as the standard treatment for people who do not make enough pancreatic enzymes, so the study can compare NHS7108 against an established therapy.

What is already known about the treatment

Zenpep delayed-release capsule
Zenpep is an oral capsule taken by mouth, usually swallowed with meals or snacks so the digestive enzymes can mix with food in the gut. It is a well-known medicine used to treat exocrine pancreatic insufficiency, a condition in which the pancreas does not make enough digestive enzymes; it is widely described in medical practice and literature as pancreatic enzyme replacement therapy. Its active substances are amylase, lipase, and protease, which help break down starches, fats, and proteins, and it is classified as a digestive enzyme replacement medicine.
NHS7108 capsules
NHS7108 is an oral capsule taken by mouth, designed to be used with food to help digestion in people with poor pancreatic enzyme function. It is an investigational medicine, meaning it is still being studied in clinical trials and is not yet an established treatment in routine medical use. Its active substance is triacylglycerol lipase, an enzyme that breaks down fats into smaller parts the body can absorb, and it is classified as a lipase-based digestive enzyme medicine.

Investigated diseases

Exocrine Pancreatic Insufficiency - Exocrine pancreatic insufficiency is a condition in which the pancreas does not make enough digestive enzymes. As a result, food is not broken down well, especially fats, proteins, and some nutrients. It often develops gradually and may begin with mild digestive problems that become more noticeable over time. Common changes include frequent loose stools, greasy stools, bloating, and weight loss due to poor absorption of nutrients.