Clinical trial NCT04991311: The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Official title: A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Short Bowel Syndrome
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Absorption of Wet Weight/Fluids
timeFrame: from Week 0 (baseline) to Week 24
Secondary outcomes:
measure: Change in Absorption of Energy
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Carbohydrates
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Lipids
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Proteins
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Sodium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Potassium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Calcium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Absorption of Magnesium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly Parenteral Support (PS) Volume
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Volume
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Carbohydrates
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Carbohydrates
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Lipids
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Lipids
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Proteins
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Proteins
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Sodium
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Sodium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Potassium
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Potassium
timeFrame: from Week 0 (baseline) to Week 24
measure: Change in Weekly PS Magnesium
timeFrame: from Week 0 (baseline) to Week 12
measure: Change in Weekly PS Magnesium
timeFrame: from Week 0 (baseline) to Week 24
measure: Anti-glepaglutide Antibodies
timeFrame: Week 56
measure: Reactivity to ZP1848
timeFrame: Week 56
measure: Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)
timeFrame: Week 56
measure: Glepaglutide Neutralizing Antibodies
timeFrame: Week 56
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Zealand Pharma
name: Zealand Pharma
role: STUDY_DIRECTOR
References: