A Phase 3 interventional study of Glepaglutide and Placebo in Short Bowel Syndrome, sponsored by Zealand Pharma. Recruiting at 33 sites in 14 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Zealand Pharma · Phase 3, Interventional, and Treatment
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.
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).
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's planned enrollment of 90 is above the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Glepaglutide
Placebo for glepaglutide
Other: Placebo
Subcutaneous (SC) injections twice weekly
Also known as: ZP1848
SC injections twice weekly
Change in weekly Parenteral Support (PS) volume
Time frame: Baseline to Week 24
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
Time frame: Baseline to Week 52
Proportion of participants achieving clinical response
Defined as achieving a reduction of at least 20% in weekly PS volume
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
PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'
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
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Glepaglutide