Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Overview

About this study

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). 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:

  • Signed informed consent.
  • Either of the following:
    • Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence; OR
    • Completed the Phase 2 trial (ZP1848-15073).

Exclusion Criteria:

  • Withdrew consent from lead-in or Phase 2 trial.
  • 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 confounds planned assessments of the trial.
  • Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3 months.
    • Note: Prior 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. 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.

Additional Exclusion Criteria Applicable for Patients from the Phase 2:

Trial Patients from the ZP1848-15073 trial (Phase 2 trial) must be excluded from this trial if any of the following criteria are met:

  • Not having a diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm [equal to 79 inches] with the latest intestinal resection being at least 6 months prior to Screening;
  • Restorative surgery planned in the trial period;
  • SBS-related hospitalizations within 30 days prior to screening;
  • Not maintaining a stable PS volume for at least 2 weeks.
    • Note: PS volume is considered stable if both of the criteria below are fulfilled:
    • Actual PS usage (volume and content) matches prescribed PS (± 10% deviation in volume is acceptable); and
    • Urine volume is on average ≥ 1 L per day and ≤ 2.5 L per day.
  • Not willing to adhere to an individual pre-defined drinking menu during 48-hours measurement periods;
  • Not having a colonoscopy performed during Screening (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 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) will suffice at the discretion of the Investigator.
  • Not being able to separate stool and urine during the 48-hours measurement periods;
  • Any history of colon cancer;
  • History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years;
  • Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or having a fistula interfering with the trial assessments;
  • Bowel obstruction or recent history of sub-ileal events;
  • Human immunodeficiency virus (HIV) positive, acute liver disease, or unstable chronic liver disease;
  • 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 screening ECG as judged by the Investigator;
  • Repeated (2 or more consecutive measurements) systolic blood pressure measurements >180 mm Hg;
  • Systemic immunosuppressive therapy that has been introduced or has been unstable within 3 months prior to Screening;
  • Unstable biological therapy (e.g., TNF-α (anti-tumor necrosis factor), natalizumab, etc.), including significant changes in doses or switch of drug within 6 months prior to Screening;
  • Unstable doses within 2 weeks prior to screening:
    • Antimotility drugs; e.g., loperamide, diphenoxylate, codeine or other opiates;
    • H2 antagonists;
    • Anti-diarrheal agents;
    • Bile acid sequestering agents;
    • Oral glutamine;
    • Proton pump inhibitors;
    • Diuretics;
    • Systemic antibiotics or antibiotics affecting the gastrointestinal tract;
    • Oral rehydration fluids.
  • 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.

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

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John DiBaise, M.D.

Contact us for the latest status

Contact information:

Pooja Keshav

(480) 301-4226

Bhakta.Pooja@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20490426

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