EASE SBS 6 (Efficacy And Safety Evaluation Of Glepaglutide In Treatment Of SBS)

Overview

About this study

The purpose of this trial is to evaluate the long-term safety and efficacy of treatment with glepaglutide 10 mg TW in adult patients with SBS rolling over from the EASE SBS 2 or EASE SBS 3 trial. As the EASE SBS 2 and EASE SBS 3 trials are being closed prematurely, patients should have the opportunity to continue their glepaglutide treatment to ensure continuity of care. Furthermore, the 10 mg TW dosage is selected based on the findings of the pivotal EASE SBS 1 trial and is intended to be the marketed dose of glepaglutide.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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:

  • The patient must be excluded from this trial if any of the following criteria are met: 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.

  • 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. 21-May-2025 Zealand Pharma A/S Approve.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/05/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Hurt

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Karen Evans

(507) 422-2944

evans.karen@mayo.edu

More information

Publications

Publications are currently not available