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Clinical Trials in the USA / NCT07197944
Recruiting Phase 3

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944 · tracked via the Priya Life Science USA tracker
Sponsor
Zealand Pharma
Phase
Phase 3
Started
2026-02-11
Last updated
2026-08-12

Condition(s) studied

Short Bowel Syndrome

Investigational drug(s) / intervention(s)

GlepaglutidePlacebo

Glepaglutide: Subcutaneous (SC) injections twice weekly

Placebo: SC injections twice weekly

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
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.

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
The University of Chicago Medicine Chicago Illinois Recruiting
Washington University Center for Advanced Medicine St Louis Missouri Recruiting
Lied Transplant Center at Nebraska Medical Center Omaha Nebraska Recruiting
New York Presbyterian Hospital-Columbia University Medical Center New York New York Not Yet Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Universitätsklinikum AKH Wien Vienna State of Vienna Recruiting
Universitair Ziekenhuis (UZ) Leuven Leuven Belgium Recruiting
Rigshospitalet-Blegdamsvej 9 Copenhagen Denmark Recruiting
Helsingin Yliopistollinen Keskussairaala Helsinki Finland Recruiting
AP-HP - Hôpital Beaujon Clichy France Recruiting
Universitätsmedizin Rostock Rostock Mecklenburg-Vorpommern Recruiting
Eugastro Klinische Studien GmbH Leipzig Saxony Recruiting
Universitätsklinikum Aachen Aachen Germany Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Recruiting
Universitätsklinikum Bonn Bonn Germany Recruiting
Asklepios Klinik St. Georg Hamburg Germany Recruiting
Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely Budapest Hungary Recruiting
Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika Budapest Hungary Recruiting
Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház Budapest Hungary Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS Rome Lazio Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Italy Recruiting
Azienda Ospedale - Università Padova Padova Italy Recruiting
Radboud Universitair Medisch Centrum Nijmegen Gelderland Recruiting
Oslo Universitetssykehus HF, Ullevål Oslo Norway Recruiting
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi Lodz Lódzkie Recruiting
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego Warsaw Poland Recruiting
Hospital General Universitario Gregorio Marañon Madrid Madrid Recruiting
Hospital Universitario 12 de Octubre Madrid Madrid Recruiting
Hospital Universitario Virgen del Rocio - PPDS Seville Sevilla Recruiting
Sahlgrenska Universitets sjukhuset Gothenburg Sweden Recruiting
Karolinska Universitetssjukhuset Solna Solna Sweden Recruiting

More Zealand Pharma trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07197944 on ClinicalTrials.gov ↗ ← All trials in the USA