Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glepaglutide, Placebo.
- Who it may be relevant to
- Registry conditions: Short Bowel Syndrome. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Denmark, France, Germany +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
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
- Drug Glepaglutide
Subcutaneous (SC) injections twice weekly - Other Placebo
SC injections twice weekly
Primary outcome measures
- Change in weekly Parenteral Support (PS) volume [Time frame: Baseline to Week 24]
Secondary outcome measures (10)
- Proportion of participants achieving clinical response [Time frame: Baseline to Week 52]
- Proportion of participants achieving clinical response [Time frame: Baseline to Week 20 and Week 24]
- 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]
- 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 criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 5 centers
- Universitätsmedizin Rostock — Rostock
- Eugastro Klinische Studien GmbH — Leipzig
- Charité - Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Bonn — Bonn
- Asklepios Klinik St. Georg — Hamburg
United States · 4 centers
- Washington University Center for Advanced Medicine — St Louis
- Lied Transplant Center at Nebraska Medical Center — Omaha
- New York Presbyterian Hospital-Columbia University Medical Center — New York
- Vanderbilt University Medical Center — Nashville
Spain · 3 centers
- Hospital General Universitario Gregorio Marañon — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario Virgen del Rocio - PPDS — Seville
Poland · 2 centers
- Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi — Lodz
- Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego — Warsaw
Sweden · 2 centers
- Sahlgrenska Universitets sjukhuset — Gothenburg
- Karolinska Universitetssjukhuset Solna — Solna
Austria · 1 center
- Universitätsklinikum AKH Wien — Vienna
Denmark · 1 center
- Rigshospitalet-Blegdamsvej 9 — Copenhagen
France · 1 center
- AP-HP - Hôpital Beaujon — Clichy
Hungary · 1 center
- Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika — Budapest
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS — Rome
Netherlands · 1 center
- Radboud Universitair Medisch Centrum — Nijmegen
Norway · 1 center
- Oslo Universitetssykehus HF, Ullevål — Oslo
Identifiers
NCT: NCT07197944 · ZP1848-23029 · 2024-512486-14-00 · U1111-1302-6092