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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521816-20-00

Enrollment

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine Pancreatic Insufficiency

Brief summary

1. Number of participants reporting 1 or more adverse events (AE), 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. Change from baseline in the CNA after 14-day NHS7108 treatment

Detailed description

1. Change from baseline in the coefficient of fat absorption (CFA) after 14-day NHS7108 treatment as compared to Zenpep®, 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. Change from baseline in the GI symptoms score (included in the eDiary) after 14-day NHS7108 treatment, 4. Stool frequency as assessed by the eDiary, 5. Stool consistency as assessed by the Bristol Stool Scale (included in the eDiary)

Interventions

DRUGZenpep delayed-release capsule

DRUGNHS7108 capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Number of participants reporting 1 or more adverse events (AE), 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. Change from baseline in the CNA after 14-day NHS7108 treatment	—

Secondary

Measure	Time frame
1. Change from baseline in the coefficient of fat absorption (CFA) after 14-day NHS7108 treatment as compared to Zenpep®, 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. Change from baseline in the GI symptoms score (included in the eDiary) after 14-day NHS7108 treatment, 4. Stool frequency as assessed by the eDiary, 5. Stool consistency as assessed by the Bristol Stool Scale (included in the eDiary)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: May 20, 2026