DRUG
Glepaglutide
Subcutaneous (SC) injections twice weekly
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Status
Recruiting
Phase
Phase 3
Enrollment
90
Locations
23
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
Interventions
Treatment arms and agents.
OTHER
Placebo
SC injections twice weekly
Timeline
From registration to results.
First posted
Sep 30, 2025
Study start
Feb 11, 2026
Primary completion
Oct 23, 2028
Study completion
Feb 28, 2032
Results posted
Not reported
Registry updated
Apr 20, 2026
Outcomes
What the study measures.
Primary outcomes
Change in weekly Parenteral Support (PS) volume
Time frame · Baseline to Week 24
Secondary outcomes
Proportion of participants achieving clinical response
Time frame · Baseline to Week 52
Defined as achieving a reduction of at least 20% in weekly PS volume
Proportion of participants achieving clinical response
Time frame · Baseline to Week 20 and Week 24
Defined as achieving a reduction of at least 20% in weekly PS volume
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame · Baseline to Week 52
Proportion of participants with a reduction in days on PS ≥1 day/week
Time frame · Baseline to Week 24
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Time frame · Baseline to Week 52
Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)
Time frame · Baseline to Week 24
Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status
Time frame · Week 24
PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'
Change in weekly PS volume
Time frame · Baseline to Week 12
Change in weekly PS volume
Time frame · Baseline to Week 8
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame · Baseline to Week 52
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
23 registered sites.
Austria · Denmark · France · Germany · Hungary · Italy · Netherlands · Norway · Poland · Spain · Sweden · United States. Showing up to 24 locations stored in the fast local snapshot.
Washington University Center for Advanced Medicine
St Louis, Missouri, United States
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Universitätsklinikum AKH Wien
Vienna, State of Vienna, Austria
Rigshospitalet-Blegdamsvej 9
Copenhagen, Denmark
AP-HP - Hôpital Beaujon
Clichy, France
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Eugastro Klinische Studien GmbH
Leipzig, Saxony, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Budapest, Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS
Rome, Lazio, Italy
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands
Oslo Universitetssykehus HF, Ullevål
Oslo, Norway
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz, Lódzkie, Poland
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, Poland
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Sahlgrenska Universitets sjukhuset
Gothenburg, Sweden
Karolinska Universitetssjukhuset Solna
Solna, Sweden
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Glepaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
Zealand Pharma · Short Bowel Syndrome (SBS)
Phase 3
Active, not recruiting
28
2026-07
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Zealand Pharma · Short Bowel Syndrome
Phase 3
Active, not recruiting
129
2026-02
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
Zealand Pharma · Short Bowel Syndrome
Phase 3
Active, not recruiting
145
2026-01
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Zealand Pharma · Short Bowel Syndrome
Phase 3
Completed
106
2025-07
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Zealand Pharma · Short Bowel Syndrome
Phase 3
Completed
12
2024-11
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Zealand Pharma · Healthy
Phase 1
Completed
85
2021-07
Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
Zealand Pharma · Renal Impairment
Phase 1
Completed
16
2020-11
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Zealand Pharma · Healthy Subjects
Phase 1
Completed
75
2017-12
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Put the record in context.
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