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RecruitingPhase 3

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Zealand Pharma · NCT07197944

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
90
US sites recruiting
5
Study start
February 11, 2026
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.

Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.

Being studied: Glepaglutide; Placebo

Conditions: Short Bowel Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • Signed informed consent;
  • Age of 18 to 90 years;
  • A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
  • Stable PS need of ≥3 days per week;
  • No restorative surgery planned during the trial period;
  • Having a stoma or colon in continuity.

Key Exclusion Criteria

  • More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
  • Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
  • History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
  • BMI \<18.5 kg/m\^2.

Recruiting US locations

  • The University of Chicago Medicine

    Chicago, IL 60637-1443

    Site contact: Carol Semrad · 773-702-6921 · csemrad@medicine.bsd.uchicago.edu

  • Washington University Center for Advanced Medicine

    St Louis, MO 63110

    Site contact: Matthew Ciorba, MD · 314-273-4543 · mciorba@wustl.edu

  • Lied Transplant Center at Nebraska Medical Center

    Omaha, NE 68105

    Site contact: David Mercer · 402-559-2556 · dmercer@unmc.edu

  • UPMC Starzl Transplantation Institute

    Pittsburgh, PA 15213

    Site contact: Ruy Cruz, MD · 412-647-0320 · cruzrj2@upmc.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Dawn Adams · (615) 322-0128 · dawn.w.adams@vanderbilt.edu

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS (NCT07197944) | Bored Studies