​A study to evaluate safety and explore efficacy of new lipase NHS7108 compared with pancrelipase in adult participants with exocrine pancreatic insufficiency

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aimmune Nestle Health Science US R&D LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-05-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Aimmune-Nestle health science US R&D LLC

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

​​Safety of different doses of NHS7108 administered daily for 14 days in participants with exocrine pancreatic insufficiency (EPI).
​Coefficient of nitrogen absorption (CNA) will be measured as part of safety​

Secondary objectives 2

1. ​​1. The effect of different doses of NHS7108 administered for 14 days in participants with EPI on fat absorption​
2. 2. Effects of NHS7108 on gastrointestinal (GI) symptoms

Conditions and MedDRA coding

​​Exocrine Pancreatic Insufficiency​

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
2. 2. Participants with clinically confirmed* chronic established (not due to a transient clinical diagnosis, i.e., acute pancreatitis) EPI and with a clinical indication for PERT. *Fecal Elastase < 200 µg/g due to, but not limited to, the following causes: total or partial pancreatectomy, CP supported by diagnostic imaging, or CF. If not available at time of screening, a baseline fecal elastase assessment will be performed for the purpose of this study.
3. 3. CFA off PERT of <80% at screening.
4. please refer to the protocol for the full list of inclusion criteria
5. 4. Normal body mass index (BMI) by age and sex to ensure participant’s EPI is adequately controlled in the opinion of the investigator (BMI of at least 17.0 and no greater than 35.0 kg/m²)

Exclusion criteria 10

1. 10. Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
2. 13. Participant has any clinically significant abnormalities in hematology, coagulation, clinical chemistry, or urinalysis at screening as judged by the Investigator OR as detailed below: • Estimated glomerular filtration rate < 60 mL/min at screening visit. • Total bilirubin > 1.5 × upper limit of normal (ULN) at screening visit. • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × ULN at screening visit.
3. 2. Previous GI surgery, except for non-invasive neonatal or early childhood procedures such as correction of hypertrophic pyloric stenosis, surgical correction of Meckel's diverticulum, volvulus, or intestinal intussusception. Hernia repair, appendectomy, cesarean section, tubal ligation, hysterectomy, polypectomy, hemorrhoidectomy, or cholecystectomy are allowed if performed at least 2 years before randomization and have no impact on intestinal transit or absorption.
4. 3. Participants on enteral feeding.
5. 4. Participants with celiac disease.
6. 5. Known allergy or adverse reaction history to any component of NHS7108, Zenpep, Omega-3 oil, and/or to any other product administered during the study, including the blue dye.
7. 7. Concurrent conditions having a clinically significant impact on GI motility function, with the exception of pancreatic insufficiency due to pancreatectomy or CP.
8. 8. Any significant clinical/laboratory/radiological sign of unstable or unexpectedly deteriorating respiratory disease during the study duration, at the discretion of the Investigator.
9. 9. Omega-3 supplements are prohibited during all the study periods and should be stopped at least 7 days prior to the baseline off-treatment fat absorption assessments.
10. please refer to the protocol for the full list of exclusion criteria

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1. Number of participants reporting 1 or more adverse events (AE)
2. ​2. Changes from baseline in safety parameters including clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examination after 14-day NHS7108 treatment
3. 3. ​Change from baseline in the CNA after 14-day NHS7108 treatment

Secondary endpoints 5

1. ​1. Change from baseline in the coefficient of fat absorption (CFA) after 14-day NHS7108 treatment as compared to Zenpep®​
2. 2. ​Omega-3 absorption test: change from baseline in post-prandial eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) content of plasma over a 24-hour period following a standard breakfast after 14 day NHS7108 treatment
3. 3. Change from baseline in the GI symptoms score (included in the eDiary) after 14-day NHS7108 treatment
4. 4. ​Stool frequency as assessed by the eDiary
5. 5. Stool consistency as assessed by the Bristol Stool Scale (included in the eDiary)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aimmune Nestle Health Science US R&D LLC

Sponsor organisation

Aimmune Nestle Health Science US R&D LLC

Address

8000 Marina Boulevard Suite 300

City

Brisbane

Postcode

94005-1884

Country

United States

Scientific contact point

Organisation

Aimmune Nestle Health Science US R&D LLC

Contact name

Nestle Global Services Uk Limited

Public contact point

Organisation

Aimmune Nestle Health Science US R&D LLC

Contact name

Nestle Global Services Uk Limited

Third parties 7

Locations

5 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications