EPIC
Research type
Research Study
Full title
A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency (EPIC)
IRAS ID
1012859
Contact name
Monique Bunyan
Contact email
Sponsor organisation
Aimmune Nestle Health Science
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI. In this study, all participants will take NHS7108 daily for 14 days and a matching dose of standard-of-care, pancrelipase (Zenpep®) for 14 days according to Treatment Sequence assignment. Both NHS7108 and Zenpep® are oral capsules that will be taken with each of the daily 3 meals and 2 snacks. Participants will interrupt all of their usual pancrelipase/pancreatin treatment for up to 8 days during screening and for the entire 2 treatment periods, where they will take either the new lipase NHS7108 or a matching dose of the standard of care pancrelipase (Zenpep®).
Participants will be asked to stay in a setting that allows controlled diet and faecal collection for approximately 6 days during the screening period and again for 7 days at the end of each treatment period. During these 3 supervised periods, they will receive a standardised diet with a predefined amount of fat and protein, all stools will be collected in special containers and during the last day of the treatment period, blood samples will be obtained to measure fat absorption. These are essential to ensure valid assessment of participants’ fat and protein absorption. Outside the 3 supervised periods, participants will be provided with guidelines and recommendations to create their own home-controlled meals and snacks according to their preferences for the remainder of the study duration.
This study is being sponsored by Aimmune Nestlé Health Science US R&D, LLC
REC name
London - West London & GTAC Research Ethics Committee
REC reference
26/LO/0181
Date of REC Opinion
8 Apr 2026
REC opinion
Further Information Favourable Opinion