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Study of NHS7108 for Exocrine Pancreatic Insufficiency

This study is testing a new medication called NHS7108 for adults with Exocrine Pancreatic Insufficiency (EPI), a condition where your pancreas doesn't make enough enzymes to digest food. NHS7108 is a modified enzyme designed to help with digestion. The study aims to see how safe different doses of NHS7108 are and to explore how well it works compared to a standard treatment, Zenpep®. You would take either NHS7108 or Zenpep® capsules daily for 14 days, and then switch to the other medication for another 14 days. We're looking for 66 participants aged 18 to 85 to join this study.

Study design
This study is testing different doses of NHS7108 against Zenpep® in 66 participants. It's an interventional study, meaning participants will receive specific treatments.
What's involved
You would take oral capsules daily for two 14-day periods, interrupting your usual pancreatic enzyme treatment. You will have screening visits and follow-up visits, which may include physical examinations.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured at 14 days after NHS7108 treatment and at an end-of-study/safety follow-up visit.

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NCT07559175

A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.

Not Yet Recruiting
PHASE2Ages 18–85InterventionalTreatment
Aimmune Nestlé Health Science US R&D, LLC
~66 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:NHS7108Zenpep®

At a glance

Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 14 days after NHS7108 Treatment
+24 more outcomes measured

Conditions

Exocrine Pancreatic Insufficiency (EPI)
Cystic Fibrosis (CF)
Pancreatic Enzyme Abnormality
Pancreatic Diseases

Explore related trials

Cystic FibrosisPancreatic DisorderPancreatic Insufficiency

Where it's being run

30 sites across 18 states
Bulgaria4
Hungary3
Italy3
Spain3
California2
Ohio2
United Kingdom2
Arizona1

Study leadership

  • Monique Bunyan · STUDY_DIRECTOR · Aimmune Nestlé Health Science US R&D, LLC (Role: Associate Clinical Project Manager)

Who to contact

Heike Wedekind
[email protected]
+49 160 8821017
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Non-sterilized male participants are eligible to participate if they agree to one of the following starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up: Must agree to stay abstinent (where abstinence is the preferred and usual lifestyle of the participant), OR male participants with a female partner of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method). Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration. These requirements also apply to participants in a same sex relationship.
Male participants must agree not to donate sperm starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up.
Female participants of childbearing potential (as defined in Appendix 4) are eligible to participate if they meet the following criteria: Agree not to become pregnant during the clinical study period and until the end-of-study safety follow-up. Have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1. If heterosexually active, must agree to consistently use a form of highly effective birth control, in combination with a barrier method starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up, OR agree to stay abstinent (where abstinence is the preferred and usual lifestyle of the participant), starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up. These requirements do not apply to participants in a same sex relationship.
Female participants of nonchildbearing potential are eligible to participate if one of the following conditions apply: Must have a confirmed clinical history of sterility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the participant's medical records, medical examination, or medical history interview). Must be postmenopausal as defined as: amenorrhea for at least 1 year prior to screening and a laboratory confirmed serum follicle-stimulating hormone (FSH) level ≥ 40 mIU/mL. Female participants on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the non-estrogen hormonal highly effective contraception methods from screening until at and continuing throughout the clinical study period, and until the end-of-study safety follow-up if they wish to continue their HRT during the study.
Female participants must agree not to donate ova starting at screening and continuing throughout the clinical study period, and until the end-of-study safety follow-up.
For WOCBP only, serum pregnancy test will be performed at screening and urine pregnancy tests will be performed at the timepoints outlined in the SoA.
The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. 8. Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 9. Participants agree not to participate in another interventional study while participating in the study.

Exclusion

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. 14. Positive human immunodeficiency virus (HIV) antibody test. 15. 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. 16. 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. 17. Concurrent drug or alcohol addiction that in the opinion of the Investigator would preclude participation and compliance with the study procedures.

What this trial measures

  • 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.14 days after NHS7108 Treatment

    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.

  • 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.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.

    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.

  • 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.After 14 -day NHS7108 treatment

    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)

  • 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.After 14 -day NHS7108 treatment

    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)

  • 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.After 14 -day NHS7108 treatment

    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).

  • 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.After 14 -day NHS7108 treatment.

    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).

  • 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.After 14 -day NHS7108 treatment

    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)).

  • 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.After 14 -day NHS7108 treatment

    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.

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology tests: 1. Platelet count (x10E3/uL) 2. White Blood Cell count with differential (percent and absolute): Neutrophils (x10E3/uL)

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology: 3\. RBC count (x10E6/uL)

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology: 4\. Hemoglobin (g/dl) 5. Mean cell hemoglobin concentration (g/dl)

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology: 6\. RBC indices: Mean Corpuscular Volume (femtoliters (fL)).

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology: 7\. Mean Corpuscular Hemoglobin (picograms (pg)).

  • 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.14-day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Hematology: 8\. Hematocrit (%), 9. Reticulocytes (%), 10. WBC count with differential (percent and absolute): Lymphocytes (%), Monocytes (%), Eosinophils(%), Basophils (%).

  • 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.14-day after NHS7108 treatment

    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).

  • 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.14 -day after NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Coagulation: 2. Prothrombin time (Sec) , 3. Activated partial thromboplastin time (Sec).

  • 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.After 14 -day NHS7108 treatment

    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).

  • 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.After 14 -day NHS7108 treatment

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Clinical Chemistry: 5. Albumin (g/dL), 6. Total protein (g/dL).

  • 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.After 14 -day NHS7108 treatment

    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).

  • 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.After 14 -day NHS7108 treatment

    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).

  • 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.After 14 -day NHS7108 treatment

    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.

  • 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.Serum Beta-HCG pregnancy test (mIU/mL) (at screening) and urine pregnancy tests (at all other timepoints) as needed for women of childbearing potential.

    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)

  • 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.Will be performed at screening in women with unconfirmed reproductive potential status only (to confirm postmenopausal state).

    Endpoint: Changes from baseline in safety parameters include clinical laboratory tests, which include- Other Screening Tests: 1. Follicle Stimulating Hormone- FSH (IU/L).

  • 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 safety14 days after NHS7108 Treatment

    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)

  • 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 safetyAfter 14 days NHS7108 treatment

    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 (%).