Recruiting
Phase 3

Glepaglutide

Sponsor:

Zealand Pharma

Code:

NCT07197944

Conditions

Short Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Glepaglutide

Placebo

Study Details

Brief summary:

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.

Conditions

Short Bowel Syndrome

Study ID

NCT07197944

Start date

Feb 11, 2026

Status verified date

Jul, 2026

Completion date

Feb 28, 2032

Anticipated

Primary completion date

Oct 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glepaglutide Group

placebo comparator: Placebo Group

Placebo for glepaglutide

Interventions

Glepaglutide

Subcutaneous (SC) injections twice weekly

Placebo

SC injections twice weekly

Primary outcome measure

  • Change in weekly Parenteral Support (PS) volume [ Time Frame: Baseline to Week 24 ]

Central Contacts and Locations

Locations

The University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637-1443

Contacts

Carol Semrad

773-702-6921csemrad@medicine.bsd.uchicago.edu

Washington University Center for Advanced Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Matthew Ciorba, MD

314-273-4543mciorba@wustl.edu

Lied Transplant Center at Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

David Mercer

402-559-2556dmercer@unmc.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Dawn Adams

(615) 322-0128dawn.w.adams@vanderbilt.edu

More Information

Sponsor

Zealand Pharma

Last update posted

Aug 12, 2026

Last verified

Jul, 2026

Keywords

  • Intestinal Failure
  • Pathologic Processes
  • Malabsorption Syndromes
  • Intestinal Diseases
  • Gastrointestinal Diseases
  • Digestive System Diseases
  • Postoperative Complications
  • Short Bowel Syndrome
  • Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Zealand Pharma on 2026-08-12.