Current partner codePEPTIDESDE
NCT04881825·Phase 3·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 3

Enrollment

129

Locations

19

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Glepaglutide

Glepaglutide will be delivered in a single-use autoinjector.

Timeline

From registration to results.

  1. First posted

    May 11, 2021

  2. Study start

    Jun 16, 2021

  3. Primary completion

    Apr 2026

  4. Study completion

    Apr 2026

  5. Results posted

    Not reported

  6. Registry updated

    Feb 2, 2026

Outcomes

What the study measures.

Primary outcomes

Incidence and type of Adverse Events (AEs)

Time frame · After 108 weeks

For AEs with onset or worsening following Visit 1

Secondary outcomes

Incidence and type of Serious Adverse Events (SAEs)

Time frame · After 108 weeks

For AEs with onset or worsening following Visit 1

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

Time frame · After 108 weeks

For AEs with onset or worsening following Visit 1

Change in body temperature

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

Change in heart rate

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

Change in blood pressure

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

Seated diastolic and systolic blood pressure

Change in body weight

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

Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG)

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

Change in hematology - hemoglobin

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

Change in hematology - hematocrit

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

Change in hematology - white blood cell count

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
90 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127) Exclusion Criteria: * 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

Study locations

19 registered sites.

Belgium · Denmark · France · Germany · Netherlands · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Georgetown University Medical Center

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

Mayo Clinic College of Medicin

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Vanderbilt University Medical Center, Nashville

Nashville, Tennessee, United States

Universitair Ziekenhuis Leuven

Leuven, Belgium

Rigshospitalet

Copenhagen, Denmark

Hôpital Beaujon

Clichy, France

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Universitätsmedizin Rostock

Rostock, Germany

UMC Radboud Nijmegen

Nijmegen, Netherlands

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Poland

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

Skawina, Poland

St Mark's Hospital

Harrow, United Kingdom

UCLH Foundation NHS Trust

London, United Kingdom

Norfolk and Norwich University Hospitals

Norwich, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Glepaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.