Actively Recruiting
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Led by Zealand Pharma · Updated on 2026-04-20
90
Participants Needed
23
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 to 90 years
- Diagnosis of short bowel syndrome with small bowel length less than 200 cm in continuity
- Stable need for parenteral support at least 3 days per week
- No planned restorative surgery during the trial period
- Presence of a stoma or colon in continuity
You will not qualify if you...
- More than 2 hospitalizations related to short bowel syndrome or parenteral support within 6 months before screening
- Poorly controlled inflammatory bowel disease that is moderately or severely active or presence of fistula interfering with trial measurements
- History of colorectal cancer or other cancers unless disease-free for at least 5 years, except certain treated skin or cervical cancers
- Ongoing bowel obstruction
- Body mass index (BMI) below 18.5 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Washington University Center for Advanced Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Actively Recruiting
3
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
Universitätsklinikum AKH Wien
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
6
Rigshospitalet-Blegdamsvej 9
Copenhagen, Denmark, 2100
Actively Recruiting
7
AP-HP - Hôpital Beaujon
Clichy, France, 92118
Actively Recruiting
8
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Actively Recruiting
9
Eugastro Klinische Studien GmbH
Leipzig, Saxony, Germany, 4103
Actively Recruiting
10
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
11
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
12
Asklepios Klinik St. Georg
Hamburg, Germany
Actively Recruiting
13
Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Budapest, Hungary, 1082
Actively Recruiting
14
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS
Rome, Lazio, Italy, 00136
Actively Recruiting
15
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
16
Oslo Universitetssykehus HF, Ullevål
Oslo, Norway, 0450
Actively Recruiting
17
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz, Lódzkie, Poland, 90-531
Actively Recruiting
18
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, Poland, 00-416
Actively Recruiting
19
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
20
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
21
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain, 41013
Actively Recruiting
22
Sahlgrenska Universitets sjukhuset
Gothenburg, Sweden, 413 46
Actively Recruiting
23
Karolinska Universitetssjukhuset Solna
Solna, Sweden, 171 64
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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