Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

NCT04881825 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: ZP1848-201102020-005502-25U1111-1261-3358
• Study Type: interventional
• Target: 129
• Locations: 8 countries
• Sites: 19

Brief Summary

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence and type of Adverse Events (AEs)

  For AEs with onset or worsening following Visit 1

  After 108 weeks

Secondary Outcomes (50)

• Incidence and type of Serious Adverse Events (SAEs)

  After 108 weeks

• Incidence and type of Adverse Events of Special Interest (AESIs)

  After 108 weeks

• Change in body temperature

  Week 0 in lead-in trial (EASE SBS 1), Week 108

• Change in heart rate

  Week 0 in lead-in trial (EASE SBS 1), Week 108

• Change in blood pressure

  Week 0 in lead-in trial (EASE SBS 1), Week 108

Study Arms (1)

once-weekly glepaglutide

EXPERIMENTAL

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Drug: Glepaglutide

Interventions

Glepaglutide DRUG

Glepaglutide will be delivered in a single-use autoinjector.

Also known as: ZP1848

once-weekly glepaglutide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activity
• Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

You may not qualify if:

• Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial
• Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator
• Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed
• Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (19)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Mayo Clinic College of Medicin

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Vanderbilt University Medical Center, Nashville

Nashville, Tennessee, 68198-3285, United States

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Beaujon

Clichy, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

UMC Radboud Nijmegen

Nijmegen, Netherlands

Location

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Poland

Location

Szpital Skawina sp. z o.o. im. Stanley Dudricka

Skawina, Poland

Location

St Mark's Hospital

Harrow, United Kingdom

Location

UCLH Foundation NHS Trust

London, United Kingdom

Location

Norfolk and Norwich University Hospitals

Norwich, United Kingdom

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zealand Pharma

  Zealand Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 11, 2021
• Study Start: June 16, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DK (1); GB (3); PL (2); NL (1); DE (5); FR (2); US (4)