A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide in patients with short bowel syndrome (SBS)

Phase 3

Completed

• Conditions: Short Bowel Syndrome; 10025477

• Registration Number: NL-OMON52468
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* Age * 18 years and * 90 years at Screening.
* Diagnosis of SBS defined as remaining small bowel in continuity of estimated
less than 200 cm [equal to 79 inches] and with the latest intestinal resection
being at least 6 months prior to Screening and considered stable with regard to
PS need.
* No restorative surgery planned in the trial period.
* Willing to adhere to an individual pre-defined drinking menu during 48-hours
measuring intervals.
* Requiring PS at least 3 days per week and maintains a stable PS volume for at
least 2 weeks. PS volume is considered stable if all of the criteria below are
fulfilled:
- Actual PS usage (volume and content) matches prescribed PS (± 10% deviation
in volume is acceptable) and
- 48-hour urine volumes at 2 consecutive visits within a 2-week interval (± 4
days, i.e., visits should be 10 to 18 days apart) are similar (a maximum of ±
25% deviation is acceptable), while the oral fluid intake is constant (the two
48-hour oral intakes differ less than 10%) and maximum 3.5 L per day, and
- Urine volume is on average * 1 L per day and * 2.5 L per day

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.
* 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.
* 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
* Use of GLP-1, GLP-2, human growth hormone (HGH), somatostatin, or analogs
thereof, within 3 months prior to Screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction in weekly PS volume from baseline to Week 24</p><br>