Exocrine Pancreatic Insufficiency (EPI)Phase 2EPICNCT07559175
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
A Phase 2 study testing NHS7108 and Zenpep® in people with Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF), run by Aimmune Nestlé Health Science US R&D, LLC at 39 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality
- What is being tested?
- NHS7108 and Zenpep®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Female participants who are breastfeeding at the time of screening.
- 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.
- Participants on enteral feeding.
- Participants with celiac disease.
- 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.
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- Concurrent clinically significant, at the discretion of the Investigator, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, and seasonal allergies and childhood asthma) or any other disorder that in the opinion of the Investigator may put the participant at greater safety risk, influence response to study intervention, or interfere with study assessments.
- Concurrent conditions having a clinically significant impact on GI motility function, with the exception of pancreatic insufficiency due to pancreatectomy or CP.
- Any significant clinical/laboratory/radiological sign of unstable or unexpectedly deteriorating respiratory disease during the study duration, at the discretion of the Investigator.
- 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.
- Participants starting new medications or changing dose within 1 month before baseline off-treatment screening assessments.
- Acute use of oral or intravenous antibiotics within 2 weeks prior to the first dose of study intervention.
- Treatment with any investigational drug or device/treatment within the 30 days or 5 half-lives of the drug (whichever is longer) prior to first dose of study intervention.
- 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.
- Positive human immunodeficiency virus (HIV) antibody test.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to first dose of study intervention AND positive on reflex to hepatitis C RNA test.
- Concurrent drug or alcohol addiction that in the opinion of the Investigator would preclude participation and compliance with the study procedures.
Trial locations and contacts
39 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 7 countries
United States14 sites, 14 recruiting
- Not yet recruiting
Johns Hopkins Medicine - Pulmonary and Critical Care
Baltimore, Maryland, 21205
Christian Merlo, 4105027044, cmerlo@jhmi.edu
- Not yet recruiting
Billings Clinic Hospital - Public
Billings, Montana, 59101
Jerimiah Lysinger, 406-435-7312, jlysinger@billingsclinic.org
- Not yet recruiting
University Hospitals Cleveland Medical Center/Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Alex Gifford, 2162860709, alex.gifford@uhhospitals.org
- Not yet recruiting
The Ohio State University College of Medicine (OSUCOM)
Columbus, Ohio, 43210
Mitchell Ramsey, 6142938784, Mitchell.Ramsey@osumc.edu
- Not yet recruiting
Omnicure Clinical Research
Doral, Florida, 33172
Anneyd Avalos Penna, aavalospenamd@omnicureresearch.com
- Recruiting
Penn State Health
Hershey, Pennsylvania, 17033
Judie Howrylak, 717531564, jhowrylak@pennstatehealth.psu.edu
- Recruiting
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
Carlos Fierro, 9138254400, cfierro@jcct.com
- Not yet recruiting
University of Arkansas for Medical Sciences Hospital - University
Little Rock, Arkansas, 72205
Larry Johnson, +1(501)686-5527, LGJohnson@uams.edu
- Not yet recruiting
Keck Hospital of USC
Los Angeles, California, 90033
James Buxbaum, +(323) 409 5371, jbuxbaum@usc.edu
- Not yet recruiting
Cedars Sinai Medical Center - Inflammatory Bowel Disease Ctr
Los Angeles, California, 90048
Stephen Pandol, (323) 423-4139, Stephen.Pandol@cshs.org
- Not yet recruiting
Vanderbilt University Medical Center - Pulmonary Hospital - University
Nashville, Tennessee, 37232
James Tolle, 615-322-2386, james.j.tolle@vumc.org
- Not yet recruiting
University of Oklahoma Health Sciences Center - Pediatrics Hospital - University
Oklahoma City, Oklahoma, 73104
Nighat Mehdi, Nighat-Mehdi@ou.edu
- Not yet recruiting
Advent Health Medical Group
Orlando, Florida, 32804
Mustafa Arain, 6122961380, mustafa.arain.md@adventhealth.com
- Not yet recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Amar Thosani, 9732024349, athosani@honorhealth.com
Italy6 sites, 6 recruiting
- Not yet recruiting
AOU Policlinico G. Rodolico - Ospedale San Marco - Broncopneumologia Pediatrica e Fibrosi Cistica Hospital - Public
Catania, Catania, 95121
Giuseppe Parisi, +39 333 3314270, Gf.parisi@policlinico.unict.it
- Not yet recruiting
Azienda Ospedaliero Universitaria Careggi - Gastroenterologia
Florence, 50134
Andrea Galli, +39 055 2758433, andrea.galli@unifi.it
- Not yet recruiting
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino - Gastroenterologia Pediatrica e Fibrosi Cistica Academic / University Clinic
Messina, Messina, 98124
Stefano Costa, +393280652312, Stefan.costa@gmail.com
- Not yet recruiting
IRCCS Ospedale San Raffaele - Endoscopia Biliopancreatica
Milan, 20132
Gabriele Capurso, +39 02 26436548, capurso.gabriele@hsr.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Sant'Andrea
Roma, 00189
Bruno Annibale, +39 0633775695, bruno.annibale@uniroma1.it
- Not yet recruiting
Humanitas Research Hospital
Rozzano, Lombardy, 20089
Alessandro Zerbi, +390282248224, alessandro.zerbi@humanitas.it
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198
Xavier Molero Richard, 34652451010, xmolero@irblleida.cat
- Not yet recruiting
Hospital Clinic De Barcelona - Cirug-ía General y Digestiva
Madrid, Barcelona, 46026
Eva Vaquero, +349322754002675, EVAQUERO@clinic.ub.es
- Not yet recruiting
Hospital Universitario La Paz Hospital - University
Madrid, Madrid, 28046
Concepcion Prados Sánchez, +34 91 727 7587, conchaprados@gmail.com
- Recruiting
H. General de Málaga - Endocrinología
Málaga, 29010
Gabriel Olveira Fuster, 34951290000, gabrielm.olveira.sspa@juntadeandalucia.es
- Not yet recruiting
Universidad de Murcia - Hospital Universitario Virgen de la Arrixaca (HUVA)
Murcia, Murcia, 30120
Pedro Mondéjar, +34 600456562, mondejarp@gmail.com
- Recruiting
Hospital Universitario y Politecnico La Fe - Neumología
Valencia, 46026
Amparo Solé Jover, 3496-386-27-00, sole_amp@gva.es
Bulgaria4 sites, 4 recruiting
- Not yet recruiting
Medical Center Medconsult Pleven, Lovech branch
Lovech, 5500
Plamen Vyrbanov, 359882044271, vyrbanov_mclovech@abv.bg
- Not yet recruiting
Medical Center Medconsult Pleven
Pleven, 5800
Stefan Baydanov, sbaydanov_medconsult@abv.bg
- Not yet recruiting
MC Hipokrat-N - Gastroenterology
Plovdiv, 4000
Nikolay Nikolov, 35932312112, nikolay.nikolov.dr@abv.bg
- Not yet recruiting
Medical Center Excelsior base 3
Sofia, 1463
Mario Markov, 35928840759, dr.mario.markov@gmail.com
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Northern Ireland Clinical Research Facility (NICRF) Solo/Group Practice
Belfast, Northern Ireland, BT9 7AB
Damian Downey
- Not yet recruiting
Greater Glasgow and Clyde
Glasgow, G12 0XH
Macgregor Gordon, +44 01412111021, gordon.macgregor@ggc.scot.nhs.uk
- Not yet recruiting
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
Alan Steel, 442087468321, Alan.Steel@nhs.net
- Not yet recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Sanjay Pandanaboyana, 4400000000, s.pandanaboyana@nhs.net
Hungary3 sites, 3 recruiting
- Not yet recruiting
MH Egészségügyi Központ - Gasztroenterológiai Osztály
Budapest, 1062
Tibor Gyokeres, 3614752597, tiborgyokeres65@gmail.com
- Recruiting
Semmelweis Egyetem. Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika - Gasztroenterologiai Osztaly
Budapest, 1082
Pal Miheller, 3600000000, szucs.akos@gmail.com
- Recruiting
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
Csongrád, 6720
Lázsló Czakó, 36203315645, czako.laszlo@med.u-szeged.hu
Poland2 sites, 2 recruiting
- Not yet recruiting
Bonifraterskie Centrum Medyczne Sp. z o.o. Oddzial w Lodzi, Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi - Dzial Endoskopi
Lodz, Łódź Voivodeship, 93-357
Wojciech Piotrowski, 48501658212, wojtekp4@wp.pl
- Not yet recruiting
WIP Warsaw IBD Point Profesor Kierkus
Pomorskie, Warszawa, 04-501
Jaroslaw Kierkus, 48500111648, j.kierkus@med-net.pl
About this study
Official 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
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 participants 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 72-hour stool collection for approximately 7 days during the screening period and again for approximately 7 days at the end of each treatment period. During these 3 supervised periods, participants will receive a standardized diet with a predefined amount of fat and protein, 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.
Number of Participants:
Read more
The aim is to have 56 participants completing the study. Assuming approximately 14% drop-out rate, approximately 66 participants will be randomized to study intervention.
Study Arms and Duration:
The total study duration for each participant will be about 100 days (approximately 14 weeks), including:
- A screening period of up to approximately 28 days (might be extended up to a total of 56 days) prior to the first dose administration.
- A crossover treatment period (2 treatment periods: approximately 14 days each, with no washout in between). For each treatment period, study intervention will be administered 5 times a day (with 3 main meals and 2 snacks). After completion of Treatment Period 1, the participant will receive and start the new treatment for Treatment Period 2.
- An end of treatment/early discontinuation visit within approximately 7 days of the last study intervention dose.
- An end-of-study safety follow-up visit at 14 (±2) days after the last dose administration.
Very low dose group: 10 mg NHS7108 (approximately 25,000 LU)/main meal and snack; 25,000 LU Zenpep/main meal and snack (50 mg NHS7108 [approximately 125,000 LU] per day; 125,000 LU Zenpep per day)
Low dose group: 20 mg NHS7108 (approximately 50,000 LU)/main meal and 10 mg NHS7108 (approximately 25,000 LU)/snack; 50,000 LU Zenpep/main meal and 25,000 LU Zenpep/snack (80 mg NHS7108 [approximately 200,000 LU] per day; 200,000 LU Zenpep per day)
Medium dose group: 40 mg NHS7108 (approximately 100,000 LU)/main meal and 20 mg (approximately 50,000 LU) NHS7108/snack; 100,000 LU Zenpep/main meal and 50,000 LU Zenpep/snack (160 mg [approximately 400,000 LU] NHS7108 per day; 400,000 LU Zenpep per day)
High dose group: 60 mg NHS7108 (approximately 150,000 LU)/main meal and 30 mg NHS7108 (approximately 75,000 LU)/snack; 150,000 LU Zenpep/main meal and 75,000 LU Zenpep/snack (240 mg NHS7108 [approximately 600,000 LU] per day; 600,000 LU Zenpep per day).
The dose for participants < 60 kg who are assigned to the high dose group will need to be weight-adjusted to ensure that they receive no more than 10,000 LU/kg/day.
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality, Pancreatic Diseases
- Being tested
- NHS7108, Zenpep®
- Keywords
- EPIC
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHS7108Drug
NHS7108 is the experimental drug. It is a recombinant, modified version of a triacylglycerol lipase enzyme derived from the bacteria Bacillus thermoamylovorans and produced by fermentation of recombinant Escherichia coli.
Unit dose strength: 10 mg (approximately 25,000 LU) per capsule.
Zenpep®Drug
Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Dose Group | Other | 10 mg NHS7108 [approximately 25,000 LU]/main meal and snack; 25,000 LU Zenpep/main meal and snack. Receives: Drug: NHS7108; Drug: Zenpep® |
| Low Dose Group | Other | 20 mg NHS7108 [approximately 50,000 LU]/main meal and 10 mg NHS7108 [approximately 25,000 LU]/snack; 50,000 LU Zenpep/main meal and 25,000 LU Zenpep/snack. Receives: Drug: NHS7108; Drug: Zenpep® |
| Medium Dose Group | Other | 40 mg NHS7108 [approximately 100,000 LU]/main meal and 20 mg NHS7108 [approximately 50,000 LU]/snack; 100,000 LU Zenpep/main meal and 50,000 LU Zenpep/snack. Receives: Drug: NHS7108; Drug: Zenpep® |
| High Dose Group | Other | 60 mg NHS7108 [approximately 150,000 LU]/main meal and 30 mg NHS7108 [approximately 75,000 LU]/snack; 150,000 LU Zenpep/main meal and 75,000 LU Zenpep/snack. Receives: Drug: NHS7108; Drug: Zenpep® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objectives: 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.
Endpoint: Number of participants reporting 1 or more adverse events.
Events Meeting the AE Definition:
- Any abnormal laboratory test results or other safety assessments including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
- Exacerbation of a chronic or in or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
- New condition detected or diagnosed after study intervention administration even though it may have been present before the start of the study.
- Signs, symptoms, or the clinical sequelae of a suspected intervention-intervention interaction.
- Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention or a concomitant medication.
Measured: 14 days after NHS7108 Treatment
Primary Objective: 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.
A complete physical examination will be performed and include, at a minimum, assessments of general appearance, head, ears, eyes, nose, throat, neck (including thyroid), skin, cardiovascular system, respiratory system, GI system, musculoskeletal system, lymph nodes, and nervous system.
Measured: At screening and end-of-study/safety follow-up visit. A brief symptom-directed physical examination may be performed at all other visits and at any time throughout the study, as clinically indicated.
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include Blood Pressure.
Units of measurement for Blood Pressure: Millimeters of mercury (mm Hg)
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include Heart Rate.
Units of measurement for Heart Rate: Beats Per Minute (BPM)
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include respiratory rate measurement.
Units of measurement for respiratory rate measurement: breaths per minute (bpm).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include vital sign measurement, which will include body temperature.
Units of measurement for body temperature: degrees Celsius (°C).
Measured: After 14 -day NHS7108 treatment.
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include 12-Lead electrocardiogram (ECG) recording. 12-lead ECG will be recorded as single bedside measurements using an ECG machine that automatically calculates the heart rate and measures: 1. PR interval (millisecond (ms)).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include 12-Lead electrocardiogram (ECG) recording. 12-lead ECG will be recorded as single bedside measurements using an ECG machine that automatically calculates the heart rate and measures: 2. QRS, and QT (QT interval corrected for heart rate using Fridericia's correction [QTcF]) intervals.
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology tests:
- Platelet count (x10E3/uL)
- White Blood Cell count with differential (percent and absolute): Neutrophils (x10E3/uL)
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:
- RBC count (x10E6/uL)
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:
- Hemoglobin (g/dl) 5. Mean cell hemoglobin concentration (g/dl)
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:
- RBC indices: Mean Corpuscular Volume (femtoliters (fL)).
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:
- Mean Corpuscular Hemoglobin (picograms (pg)).
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology:
- Hematocrit (%), 9. Reticulocytes (%), 10. WBC count with differential (percent and absolute): Lymphocytes (%), Monocytes (%), Eosinophils(%), Basophils (%).
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Coagulation: 1. Fibrinogen (mg/dL), Prothrombin time (Sec) , Activated partial thromboplastin time (Sec).
Measured: 14-day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Coagulation: 2. Prothrombin time (Sec) , 3. Activated partial thromboplastin time (Sec).
Measured: 14 -day after NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 1. Bicarbonate (mmol/L), 2. Sodium(mmol/L), 3. Potassium (mmol/L), 4. Chloride (mmol/L).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 5. Albumin (g/dL), 6. Total protein (g/dL).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 7. Blood glucose (fasting at screening only) (mg/dL), 8. Phosphate (mg/dL), 9. Calcium (mg/dL), 10. Urea (mg/dL), 11. Creatinine (mg/dL), 12. Uric acid/urate (mg/dL), 13. Total and direct bilirubin (mg/dL), 14. Triglycerides (mg/dL), 15. Total Cholesterol (mg/dL).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 16. Creatine kinase (U/L), 17. AST/SGOT (U/L), 18. ALT/SGPT (U/L), 19. Alkaline phosphatase 2 (U/L), 20. GGT (U/L), 21. Lactate dehydrogenase (U/L).
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Routine Urinalysis: Leukocyte esterase, Protein, Urobilinogen, Ketones, Bilirubin, Microscopic examination (if blood, leukocytes, or protein is abnormal), Blood, pH, Nitrite, Specific gravity, Glucose.
All the above urinalysis are reported in absolute units. They are semi-quantitative. Hence no units of measurement.
Measured: After 14 -day NHS7108 treatment
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Pregnancy Testing. Highly sensitive serum Beta-HCG pregnancy test (mIU/mL) and urine pregnancy tests (no units)
Measured: Serum Beta-HCG pregnancy test (mIU/mL) (at screening) and urine pregnancy tests (at all other timepoints) as needed for women of childbearing potential.
Primary Objective: 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.
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Other Screening Tests: 1. Follicle Stimulating Hormone- FSH (IU/L).
Measured: Will be performed at screening in women with unconfirmed reproductive potential status only (to confirm postmenopausal state).
Primary Objective: 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
Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Other Screening Tests: 2. Serology: HIV antibody, hepatitis B surface antigen, and hepatitis C virus antibody, hepatitis B surface antibody and hepatitis B core antibody total. (No units)
Measured: 14 days after NHS7108 Treatment
Primary Objective: 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
Endpoint: Change from baseline in the Coefficient of Nitrogen Absorption (CNA).CNA expresses the ratio between the amount of nitrogen absorbed and the amount of nitrogen provided with the diet. It will also be analyzed from the stool collection period. CNA is calculated as follows: nitrogen intake (g) - excreted nitrogen (g)/nitrogen intake (g), expressed as percentage (%).
Measured: After 14 days NHS7108 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic Insufficiency (EPI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimmune Nestlé Health Science US R&D, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Monique Bunyan, Study director, Aimmune Nestlé Health Science US R&D, LLC (Role: Associate Clinical Project Manager)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559175
- Sponsor's protocol ID
- 2307CLI
- Acronym
- EPIC
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No