A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
This research study is looking into a new medication called NHS7108, which aims to help adults with Exocrine Pancreatic Insufficiency (EPI) digest their food better. The study will compare NHS7108 to Zenpep®, a common treatment for EPI, to understand its safety and how effectively it works. Participants will take both medicines at different times during the study, always as capsules with meals and snacks. Researchers will closely monitor how well fats and proteins are absorbed from food. The goal is to see if NHS7108 could be a helpful new option for managing EPI, including for those with Cystic Fibrosis or other pancreatic conditions.
At a glance
What is this study about?
This study is designed to explore a new medication, NHS7108, for adults who have a condition called Exocrine Pancreatic Insufficiency (EPI). EPI means your body doesn't make enough special juices (enzymes) in the pancreas to properly digest food, especially fats. This can lead to symptoms like stomach upset, bloating, and difficulty absorbing important nutrients. EPI can be caused by various issues, including Cystic Fibrosis (CF) or other pancreatic diseases.
The main goal of this study is twofold: first, to check how safe the new NHS7108 medicine is, and second, to see how well it helps people digest their food compared to a treatment already in use, called Zenpep®. Both NHS7108 and Zenpep® are capsules that participants will take with their daily meals and snacks. By carefully comparing these two treatments, researchers hope to understand if NHS7108 could be a valuable new option for managing EPI, potentially improving digestion and overall well-being for patients.
Participants will take different doses of NHS7108 and Zenpep® over specific periods, allowing the researchers to understand the effects across various strengths. During parts of the study, participants will follow a controlled diet, and special tests will be done to measure how much fat and protein their bodies are absorbing. This detailed approach will provide important information about how effective the new medicine is and help ensure that any potential new treatment is thoroughly evaluated for the benefit of future patients.
Key takeaways
- Tests a new EPI medicine, NHS7108, against a standard treatment, Zenpep®.
- Aims to check safety and how well it helps digest food.
- Participants take both medicines at different times, as capsules with meals.
- Involves controlled diet periods and stool collections to measure digestion.
- Study lasts about 14 weeks for each participant.
- Presents a potential new option for managing EPI.
Who may be eligible?
To join this study, you need to be an adult between 18 and 85 years old. You must have a confirmed diagnosis of Exocrine Pancreatic Insufficiency (EPI) that is long-standing and not just a temporary issue. Your doctor must also agree that you need treatment for your EPI.
There are also some health checks. Your body mass index (BMI) should be between 17.0 and 35.0 kg/m² to ensure your digestion is reasonably stable. If you take other regular medications for conditions like infections or mucus problems, or for Cystic Fibrosis (like CFTR modulators), you can usually still participate, but you'll need to have been on a stable dose for a certain amount of time before the study starts and not change them during the study.
For contraception, if you are a man, you must agree to either avoid sex or use reliable birth control if your partner could become pregnant. If your partner is pregnant or breastfeeding, you must use a condom during sex. These rules are in place to ensure safety during the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 85 years old?
- Do you have a confirmed, ongoing diagnosis of Exocrine Pancreatic Insufficiency (EPI)?
- Is your doctor treating you for EPI?
- Are you able to maintain a stable dose of other regular medications (if any) during the study?
- If male, are you willing to follow specific contraception rules?
What does participation involve?
If you decide to take part, the study will last about 100 days (roughly 14 weeks). It starts with a screening period of up to 28 days (or possibly up to 56 days) to make sure you're a good fit. During this time, and at the end of each treatment period, you'll stay in a special setting for about 7 days. Here, you'll eat a carefully controlled diet with set amounts of fat and protein, and your stool will be collected. On the last day of these stays, a blood sample will be taken to measure fat absorption. This helps the researchers accurately check how well your body is digesting food.
During the main part of the study, you'll take study medication as capsules five times a day (with three main meals and two snacks). This will involve two treatment periods, each lasting about 14 days. You'll take NHS7108 during one period and Zenpep® during the other. Your usual pancreatic enzyme treatments will be paused for up to 8 days during screening and throughout both treatment periods. Outside of your supervised stays, you'll receive guidance to help you plan your meals and snacks at home according to your preferences.
After completing the treatment periods, there will be a final visit within 7 days of your last dose, and a safety check-up about 14 days later.
Potential risks and benefits
Locations (30)
- HonorHealth Research InstituteVerified postcodeScottsdale, United States
- Keck Hospital of USCVerified postcodeLos Angeles, United States
- University of Southern California University Hospital (USCUH) - Internal MedicineVerified postcodeLos Angeles, United States
- Advent Health Medical GroupVerified postcodeOrlando, United States
- Johnson County Clin-Trials (JCCT)Verified postcodeLenexa, United States
- Maine Medical Center - Division of Pulmonary and Critical Care MedicineVerified postcodePortland, United States
- Johns Hopkins Medicine - Pulmonary and Critical CareVerified postcodeBaltimore, United States
- University Hospitals Cleveland Medical Center/Rainbow Babies & Children's HospitalVerified postcodeCleveland, United States
- The Ohio State University College of Medicine (OSUCOM)Verified postcodeColumbus, United States
- Medical Center Medconsult Pleven, Lovech branchVerified postcodeLovech, Bulgaria
- Medical Center Medconsult PlevenVerified postcodePleven, Bulgaria
- MC Hipokrat-N - GastroenterologyVerified postcodePlovdiv, Bulgaria
Common questions
What is Exocrine Pancreatic Insufficiency (EPI)?
EPI means your pancreas doesn't make enough enzymes to properly digest food, especially fats, which can lead to digestion problems.
What is the new medicine being tested?
The new medicine is called NHS7108. It's a capsule designed to help your body digest food, similar to your natural pancreatic enzymes.
Will I stop my current EPI medication?
Yes, you will need to pause your usual pancreatic enzyme treatment during parts of the study, specifically during screening and both treatment periods.
How long will I be in the study?
The total study will last for about 100 days, or roughly 14 weeks, including screening and follow-up.
What kind of tests will be done?
You'll have supervised stays where your diet is controlled, and stool samples will be collected. Blood tests will also measure how well you're digesting fats.
How to find out more
Heike Wedekind
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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