A Study to Evaluate the Effectiveness and Safety of Glepaglutide in the Treatment of Short Bowel Syndrome

Overview

About this study

The primary purpose of this trial is to confirm the effectiveness of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

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:

  • Informed consent obtained before any trial-related activity.
  • Age ≥ 18 years and ≤ 90 years at Screening.
  • Diagnosis of SBS and with the latest intestinal resection being at least 6 months prior to Screening and considered stable with regard to PS need. No restorative surgery planned in the trial period.
  • Requiring PS at least 3 days per week.
  • Willing to adhere to an individual pre-defined drinking menu during 48-hours measuring intervals.
  • Willing to maintain a stable weight (± 5%) for the duration of the trial (24 weeks).
  • Having:
    • A stoma; or
    • Colon-in-Continuity (CiC) with documented colonoscopy performed during Screening and which does not give rise to any safety concerns; and
    • Able to separate stool and urine during the 48 hours measuring intervals.
      • Note: A colonoscopy performed within 6 months prior to Screening 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) (if standard of care at site) will suffice at the discretion of the investigator.

Exclusion Criteria:

  • More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization. 
  • Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
  • Bowel obstruction. 
  • Known radiation enteritis or significant villous atrophy.
  • Cardiac disease defined as:
    • decompensated heart failure (New York Heart Association [NYHA] Class III-IV);
    • unstable angina pectoris; and/or
    • myocardial infarction within the last 6 months prior to Screening. 
  • Clinically significant abnormal ECG.
  • Repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure measurements > 180 mm Hg.
  • Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease. 
  • Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
  • Estimated creatinine clearance (CLcr; by the Cockcroft-Gault formula) < 30 mL/min.
  • Hepatic impairment defined as:
    • Total bilirubin ≥ 2 × the upper limit of normal (ULN); or
    • Aspartate aminotransferase (AST) ≥ 5 × ULN; or
    • Alanine aminotransferase (ALT) ≥ 5 × ULN.
  • Use of GLP-1, GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to Screening.
  • Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
  • Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening.
  • Unstable biological therapy (e.g., anti-TNF-α, natalizumab, etc.) within 6 months prior to Screening, including significant changes in doses or switch of drug.
  • Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods. 
  • Known or suspected hypersensitivity to glepaglutide or related products.
  • Previous exposure to glepaglutide.
  • Previous participation (randomization) in this trial.
  • Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
  • Mental incapacity or language barriers which preclude adequate understanding or cooperation, or unwillingness to comply with trial requirements.
  • Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
  • Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • An employee of the sponsor or Investigator or otherwise dependent on them.

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John DiBaise, M.D.

Open for enrollment

Contact information:

Pompa Bhattacharjee M.S.

(480) 301-4226

Bhattacharjee.Pompa@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Hurt, M.D., Ph.D.

Open for enrollment

Contact information:

Department of Medicine – Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20456808

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