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

NCT07559175 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2307CLI
• Study Type: interventional
• Target: 66
• Locations: 7 countries
• Sites: 30

Brief 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 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: 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

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

Keywords

EPIC

Outcome Measures

Primary Outcomes (25)

• 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.

  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.

  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)

  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)

  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).

  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).

  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)).

  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.

  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: 1. Platelet count (x10E3/uL) 2. White Blood Cell count with differential (percent and absolute): Neutrophils (x10E3/uL)

  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: 3\. RBC count (x10E6/uL)

  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: 4\. Hemoglobin (g/dl) 5. Mean cell hemoglobin concentration (g/dl)

  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: 6\. RBC indices: Mean Corpuscular Volume (femtoliters (fL)).

  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: 7\. Mean Corpuscular Hemoglobin (picograms (pg)).

  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: 8\. Hematocrit (%), 9. Reticulocytes (%), 10. WBC count with differential (percent and absolute): Lymphocytes (%), Monocytes (%), Eosinophils(%), Basophils (%).

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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)

  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).

  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)

  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 (%).

  After 14 days NHS7108 treatment

Other Outcomes (5)

• Exploratory Objective: A) The effect of different doses of NHS7108 administered for 14 days in participants with EPI on fat absorption

  After 14 day NHS7108 treatment

• Exploratory Objective: A) The effect of different doses of NHS7108 administered for 14 days in participants with EPI on fat absorption

  14 days after NHS7108 treatment

• Exploratory objective: B) Effects of NHS7108 on gastrointestinal (GI) symptoms

  after 14-day NHS7108 treatment

Study Arms (4)

Very Low Dose Group

OTHER

10 mg NHS7108 \[approximately 25,000 LU\]/main meal and snack; 25,000 LU Zenpep/main meal and snack.

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.

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.

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.

Drug: NHS7108; Drug: Zenpep®

Interventions

NHS7108 DRUG

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.

High Dose Group; Low Dose Group; Medium Dose Group; Very Low Dose Group

Zenpep® DRUG

Zenpep® is the active comparator. It is a combination of lipases, proteases, and amylases. Unit dose strength: 25,000 LU per capsule.

High Dose Group; Low Dose Group; Medium Dose Group; Very Low Dose Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is a male or female between 18 to 85 years of age, inclusive, at the time of signing the informed consent.
• 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.
• CFA off PERT of \<80% at screening
• 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)
• Standard-of-care medications are allowed (antibiotics, mucolytic agents, aerosols, antacids), if on stable doses for at least 1 month prior to baseline CFA and CNA assessments and must not be altered in dose or stopped during the study.
• Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators are allowed if on stable doses for at least 3 months prior to randomization. Participants should not start taking CFTR modulators during the duration of the study.
• Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male Participants:
• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aimmune Nestlé Health Science US R&D, LLC: lead
• Parexel: collaborator

Study Sites (30)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

University of Southern California University Hospital (USCUH) - Internal Medicine

Los Angeles, California, 90033, United States

Location

Advent Health Medical Group

Orlando, Florida, 32804, United States

Location

Johnson County Clin-Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Maine Medical Center - Division of Pulmonary and Critical Care Medicine

Portland, Maine, 04102, United States

Location

Johns Hopkins Medicine - Pulmonary and Critical Care

Baltimore, Maryland, 21205, United States

Location

University Hospitals Cleveland Medical Center/Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

The Ohio State University College of Medicine (OSUCOM)

Columbus, Ohio, 43210, United States

Location

Medical Center Medconsult Pleven, Lovech branch

Lovech, 5500, Bulgaria

Location

Medical Center Medconsult Pleven

Pleven, 5800, Bulgaria

Location

MC Hipokrat-N - Gastroenterology

Plovdiv, 4000, Bulgaria

Location

Medical Center Excelsior base 3

Sofia, 1463, Bulgaria

Location

MH Egészségügyi Központ - Gasztroenterológiai Osztály

Budapest, 1062, Hungary

Location

Semmelweis Egyetem. Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika - Gasztroenterologiai Osztaly

Budapest, 1082, Hungary

Location

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika

Csongrád, 6720, Hungary

Location

Humanitas Research Hospital

Rozzano, Lombardy, 20089, Italy

Location

Azienda Ospedaliero Universitaria Careggi - Gastroenterologia

Florence, 50134, Italy

Location

IRCCS Ospedale San Raffaele - Endoscopia Biliopancreatica

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Sant'Andrea

Roma, 00189, Italy

Location

WIP Warsaw IBD Point Profesor Kierkus

Pomorskie, Warszawa, 04-501, Poland

Location

H-T. Centrum Medyczne-Endoterapia

Śląskie, 43-100, Poland

Location

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, Poland

Location

Hospital Clinic De Barcelona - Cirug-ía General y Digestiva

Madrid, Barcelona, 46026, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

H. General de Málaga - Endocrinología

Málaga, 29010, Spain

Location

Hospital Universitario y Politecnico La Fe - Neumología

Valencia, 46026, Spain

Location

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Greater Glasgow and Clyde

Glasgow, G12 0XH, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Cystic Fibrosis; Pancreatic Diseases

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• Monique Bunyan

  Aimmune Nestlé Health Science US R&D, LLC (Role: Associate Clinical Project Manager)

  STUDY DIRECTOR

Central Study Contacts

Heike Wedekind

CONTACT

+49 160 8821017; heike.wedekind@parexel.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); IT (4); ES (4); GB (3); US (9); BU (4); PL (3)