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NCT Number: NCT04881825

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Glepaglutide

Drug

Glepaglutide will be delivered in a single-use autoinjector.

Other names: ZP1848

Primary outcomes

  1. Incidence and type of Adverse Events (AEs)

    Time frame: After 108 weeks

    For AEs with onset or worsening following Visit 1

Secondary outcomes

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

    Time frame: After 108 weeks

    For AEs with onset or worsening following Visit 1

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

    Time frame: After 108 weeks

    For AEs with onset or worsening following Visit 1

  3. Change in body temperature

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

  4. Change in heart rate

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

  5. Change in blood pressure

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

    Seated diastolic and systolic blood pressure

  6. Change in body weight

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

  7. 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

  8. Change in hematology - hemoglobin

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

  9. Change in hematology - hematocrit

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

  10. Change in hematology - white blood cell count

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

  11. Change in hematology - platelet count

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

  12. Change in biochemistry - sodium

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

  13. Change in biochemistry - potassium

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

  14. Change in biochemistry - chloride

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

  15. Change in biochemistry - bicarbonate

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

  16. Change in biochemistry - blood urea nitrogen

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

  17. Change in biochemistry - creatinine

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

  18. Change in biochemistry - creatinine clearance

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

  19. Change in biochemistry - glucose

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

  20. Change in biochemistry - calcium

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

  21. Change in biochemistry - phosphorous

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

  22. Change in biochemistry - alkaline phosphatase

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

  23. Change in biochemistry - alanine aminotransferase (ALT)

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

  24. Change in biochemistry - aspartate aminotransferase (AST)

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

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

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

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

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

  27. Change in biochemistry - lactic dehydrogenase

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

  28. Change in biochemistry - conjugated bilirubin

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

  29. Change in biochemistry - total bilirubin

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

  30. Change in biochemistry - total protein

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

  31. Change in biochemistry - albumin

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

  32. Change in biochemistry - amylase

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

  33. Change in biochemistry - uric acid

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

  34. Change in biochemistry - C-reactive protein

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

  35. Change in urinalysis - blood

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

  36. Change in urinalysis - glucose

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

  37. Change in urinalysis - leukocytes

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

  38. Change in urinalysis - pH

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

  39. Change in urinalysis - osmolality

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

  40. Change in urinalysis - protein

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

  41. Change in urinalysis - sodium

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

  42. Change in urinalysis - potassium

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

  43. Anti-glepaglutide antibodies

    Time frame: Week 0, Week 108

  44. Antibody reactivity to ZP1848

    Time frame: Week 0, Week 108

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

    Time frame: Week 0, Week 108

  46. Glepaglutide neutralizing antibodies

    Time frame: Week 0, Week 108

  47. Reduction in weekly Parenteral Support (PS) volume

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

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

    Time frame: 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

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

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

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

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study 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

Acronym: EASE SBS 3

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 11, 2021
Registry last updated
Feb 2, 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.

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