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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

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)

NCT07197944•Zealand Pharma

View on ClinicalTrials.gov

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

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (17)

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

Universitätsklinikum AKH Wien

Vienna, 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

Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

Rome, Lazio, Italy

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Key Dates

Start Date

February 11, 2026

Primary Completion Date

October 23, 2028

Completion Date

February 28, 2032

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Short Bowel Syndrome

Interventions

Glepaglutide

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Inclusion Criteria

Exclusion Criteria

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF