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NCT07197944PHASE3Recruiting

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Zealand Pharma

Start Date

2/11/2026

Completion Date

2/28/2032

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.

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).

Eligibility Criteria

Age Range: 18 years to 90 years

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.

Interventions

DRUG

Glepaglutide

OTHER

Placebo

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Conditions

Short Bowel Syndrome

Locations

Washington University Center for Advanced Medicine

St Louis, Missouri 63110

United States

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska 68105

United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York 10032

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Universitätsklinikum AKH Wien

Vienna, State of Vienna 1090

Austria

Rigshospitalet-Blegdamsvej 9

Copenhagen, 2100

Denmark

AP-HP - Hôpital Beaujon

Clichy, 92118

France

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern 18057

Germany

Eugastro Klinische Studien GmbH

Leipzig, Saxony 4103

Germany

Charité - Universitätsmedizin Berlin

Berlin, 10117

Germany

Universitätsklinikum Bonn

Bonn, 53127

Germany

Asklepios Klinik St. Georg

Hamburg,

Germany

Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika

Budapest, 1082

Hungary

Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

Rome, Lazio 00136

Italy

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland 6525 GA

Netherlands

Oslo Universitetssykehus HF, Ullevål

Oslo, 0450

Norway

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Lódzkie 90-531

Poland

Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego

Warsaw, 00-416

Poland

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013

Spain

Sahlgrenska Universitets sjukhuset

Gothenburg, 413 46

Sweden

Karolinska Universitetssjukhuset Solna

Solna, 171 64

Sweden