Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Short Bowel Syndrome (SBS) Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Leuven - PPDS, Leuven, Belgium

About this study

This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Has provided signed informed consent and agrees to comply with protocol requirements.
Is being

Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or
Actively treated in the EASE SBS 3 trial.

Exclusion criteria

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.
Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
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.
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.)
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.
Has a known or suspected hypersensitivity to glepaglutide or related products.
Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
Is an employee of the sponsor or investigator or otherwise dependent on them.

Treatment and study plan

Glepaglutide 10 mg

Drug

Administered twice weekly by subcutaneous injection for a maximum of 24 months

Other names: ZP1848

Primary outcomes

Number of treatment emergent adverse events (TEAEs)

Time frame: From baseline to the safety follow-up visit (A maximum of 25 months)

Secondary outcomes

Change in prescribed weekly parenteral support (PS) volume

Time frame: From baseline to Month 24 (End of Trial)

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials

Acronym: EASE SBS 6

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Nov 14, 2025
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed