A trial to assess the long-term safety and effectiveness of glepaglutide in patients with short bowel syndrome who have been previously treated with the medicine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zealand Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

23 Dec 2025 → ongoing

Decision date (initial)

2025-12-15

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Zealand Pharma A/S

External identifiers

EU CT number

2025-520775-81-00

WHO UTN

U1111-1317-8307

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety and tolerability of glepaglutide 10 mg TW in patients with SBS

Secondary objectives 1

1. To evaluate the efficacy of glepaglutide treatement in patients with SBS

Conditions and MedDRA coding

Short Bowel Syndrome

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 1. Has provided signed informed consent and agrees to comply with protocol requirements.
2. 2. Is being a. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or b. Actively treated in the EASE SBS 3 trial.

Exclusion criteria 8

1. 1. Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.
2. 2. Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
3. 3. Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial.
4. 4. Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)
5. 5. If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.
6. 6. Has a known or suspected hypersensitivity to glepaglutide or related products.
7. 7. Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
8. 8. Is an employee of the sponsor or investigator or otherwise dependent on them.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. TEAEs from baseline (Visit 1) to the safety follow-up visit

Secondary endpoints 1

1. Change in prescribed weekly PS volume from baseline to Month 24/EOT

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zealand Pharma A/S

Sponsor organisation

Zealand Pharma A/S

Address

Sydmarken 11

City

Soeborg

Postcode

2860

Country

Denmark

Scientific contact point

Organisation

Zealand Pharma A/S

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Zealand Pharma A/S

Contact name

Clinical Trial Information Desk

Third parties 11

Locations

4 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 34 files

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

Application history

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