The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

NCT ID: NCT04991311

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2023-09-05

Brief Summary

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections.

Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.

Conditions

Short Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

once-weekly glepaglutide

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

Group Type: EXPERIMENTAL

Glepaglutide

Intervention Type: DRUG

Glepaglutide will be delivered in a single-use autoinjector.

Interventions

Glepaglutide

Glepaglutide will be delivered in a single-use autoinjector.

Intervention Type: DRUG

Other Intervention Names

ZP1848

Eligibility Criteria

Inclusion Criteria

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Age greater than or equal to 18 years and less than or equal to 90 years at screening
• Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
• Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
• Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening

Exclusion Criteria

• More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
• Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
• Current bowel obstruction
• Known radiation enteritis or significant villous atrophy, e.g., due to active celiac 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
• 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
• Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zealand Pharma

Role: STUDY_DIRECTOR

Zealand Pharma

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-005194-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1260-2961

Identifier Type: OTHER

Identifier Source: secondary_id

ZP1848-20060

Identifier Type: -

Identifier Source: org_study_id