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Short Bowel SyndromePhase 3EASE SBS 3NCT04881825

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

A Phase 3 study testing Glepaglutide in people with Short Bowel Syndrome, run by Zealand Pharma at 19 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Short Bowel Syndrome
What is being tested?
Glepaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
19 sitesin 8 countries
Study dates
16 Jun 2021to 30 Apr 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 8 countries.

19 sites in 8 countries

Germany5 sites

  • Charité - Universitätsmedizin Berlin

    Berlin

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Asklepios Kliniken Hamburg GmbH

    Hamburg

  • Universitätsmedizin Rostock

    Rostock

Other trials in Germany

United States4 sites

  • Vanderbilt University Medical Center, Nashville

    Nashville, Tennessee, 68198-3285

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Mayo Clinic College of Medicin

    Rochester, Minnesota, 55905

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom3 sites

  • St Mark's Hospital

    Harrow

  • UCLH Foundation NHS Trust

    London

  • Norfolk and Norwich University Hospitals

    Norwich

Other trials in United Kingdom

France2 sites

  • Hôpital Beaujon

    Clichy

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite

Other trials in France

Poland2 sites

  • Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

    Lodz

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

    Skawina

Other trials in Poland

Belgium1 site

  • Universitair Ziekenhuis Leuven

    Leuven

Other trials in Belgium

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Netherlands1 site

  • UMC Radboud Nijmegen

    Nijmegen

Other trials in Netherlands

About this study

Official title: A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

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.

Being tested
Glepaglutide
Medical subject headings
Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlepaglutideDrug

    Also called ZP1848

    Glepaglutide will be delivered in a single-use autoinjector.

Study groups in NCT04881825
Study groupRoleWhat they receive
once-weekly glepaglutideExperimentalAll participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
Receives: Drug: Glepaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and type of Adverse Events (AEs)

    For AEs with onset or worsening following Visit 1

    Measured: After 108 weeks

Secondary outcomes (50)

  1. Incidence and type of Serious Adverse Events (SAEs)

    For AEs with onset or worsening following Visit 1

    Measured: After 108 weeks

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

    For AEs with onset or worsening following Visit 1

    Measured: After 108 weeks

  3. Change in body temperature

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

  4. Change in heart rate

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

  5. Change in blood pressure

    Seated diastolic and systolic blood pressure

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

  6. Change in body weight

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

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

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

  8. Change in hematology - hemoglobin

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

  9. Change in hematology - hematocrit

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

  10. Change in hematology - white blood cell count

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

  11. Change in hematology - platelet count

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

  12. Change in biochemistry - sodium

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

  13. Change in biochemistry - potassium

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

  14. Change in biochemistry - chloride

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

  15. Change in biochemistry - bicarbonate

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

  16. Change in biochemistry - blood urea nitrogen

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

  17. Change in biochemistry - creatinine

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

  18. Change in biochemistry - creatinine clearance

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

  19. Change in biochemistry - glucose

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

  20. Change in biochemistry - calcium

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

  21. Change in biochemistry - phosphorous

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

  22. Change in biochemistry - alkaline phosphatase

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

  23. Change in biochemistry - alanine aminotransferase (ALT)

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

  24. Change in biochemistry - aspartate aminotransferase (AST)

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

  25. Change in biochemistry - International Normalized Ratio (INR)

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

  26. Change in biochemistry - gamma-glutamyl transferase (GGT)

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

  27. Change in biochemistry - lactic dehydrogenase

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

  28. Change in biochemistry - conjugated bilirubin

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

  29. Change in biochemistry - total bilirubin

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

  30. Change in biochemistry - total protein

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

  31. Change in biochemistry - albumin

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

  32. Change in biochemistry - amylase

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

  33. Change in biochemistry - uric acid

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

  34. Change in biochemistry - C-reactive protein

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

  35. Change in urinalysis - blood

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

  36. Change in urinalysis - glucose

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

  37. Change in urinalysis - leukocytes

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

  38. Change in urinalysis - pH

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

  39. Change in urinalysis - osmolality

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

  40. Change in urinalysis - protein

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

  41. Change in urinalysis - sodium

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

  42. Change in urinalysis - potassium

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

  43. Anti-glepaglutide antibodies

    Measured: Week 0, Week 108

  44. Antibody reactivity to ZP1848

    Measured: Week 0, Week 108

  45. Cross-reactivity to glucagon-like peptide-2 (GLP-2)

    Measured: Week 0, Week 108

  46. Glepaglutide neutralizing antibodies

    Measured: Week 0, Week 108

  47. Reduction in weekly Parenteral Support (PS) volume

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

  48. Reduction of at least 20 percent in weekly PS volume

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

  49. Reduction in days on PS greater than or equal to 1 day per week

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

  50. Reduction in weekly PS volume of 100 percent (weaned off)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start16 Jun 2021
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881825
Sponsor's protocol ID
ZP1848-20110
Other IDs
2020-005502-25, U1111-1261-3358
Acronym
EASE SBS 3
Status last verified
Jan 2026
First submitted
22 Apr 2021
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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